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26 Trial(s) displayed. Page 1 2 3   Next
A phase II multicenter randomized trial evaluating 3-year disease-free survival in patients with locally advanced rectal cancer treated with chemoradiation plus induction or consolidation chemotherapy, and total mesorectal excision or non-operative management: OPRA
Category:

This study is for people with cancer of the rectum that has extended through the rectal wall (Stage II), or involves the lymph nodes outside the rectum (Stage III) who have not yet had treatment.

Patients with rectal cancer are given chemotherapy with radiation therapy (chemoradiation), and then they have surgery to remove the rectum. Sometimes after surgery, patients will have standard chemotherapy. The extra chemotherapy is given to help make sure the tumor does not come back and to try and cure patients of their cancer.

The purpose of this study is to increase the number of patients cured from their rectal cancer by giving the chemotherapy before surgery instead of after surgery. Researchers also want to find out what are the effects, good and/or bad, of having chemotherapy before surgery has on you and your rectal cancer.

You will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can select which study group you will be in. You have an equal chance of being in either group.

There are two treatment groups: You will be randomly assigned to either Group 1 or Group 2. In these treatment groups, both chemotherapy and chemoradiation will be given before surgery. When treatment is given before surgery it is called neoadjuvant treatment.

Group 1: Induction Neoadjuvant Chemotherapy (INCT) - Chemotherapy before chemoradiation

  • Chemotherapy: You will start by having 8 cycles of FOLFOX or 6 cycles of CapeOX. This part of the treatment will take approximately 16-18 weeks. Chemotherapy is given by an infusion into your vein.
  • Exams after Chemotherapy Approximately 2-6 weeks after completing chemotherapy, you will have a digital rectal exam, an endoscopic exam (looking into your rectum) called a proctoscopy or flexible sigmoidoscopy, and an MRI to monitor your tumor is recommended but not required.
  • If your surgeon discovers that your tumor has increased in size then you will be treated according to standard practice.
  • If your tumor has remained stable (same size) or decreased in size, then you will continue with study treatment.
  • Chemoradiation: If you continue with treatment, following the break you will have chemoradiation therapy for approximately 6 weeks. Along with the radiation you will receive either 5-FU or capecitabine. Your study doctor will see you periodically during the treatment to check your health status.
  • Exam after chemoradiation: Approximately 4-12 weeks after completing chemoradiation therapy, you will have a digital rectal exam and an endoscopic exam. You will also have a CT of the chest, abdomen and pelvis to make sure that the tumor will not have spread to other organs such as the liver or lungs. You will also have a rectal MRI to monitor your tumor. At this time, your surgeon will decide if you need surgery right away of if you can continue observation:
  • If your surgeon discovers that your tumor has not responded significantly to the chemotherapy and chemoradiation you will go straight to surgery. This is a standard surgical procedure that will not be modified for the purpose of the study.
  • If your surgeon discovers that your tumor has responded significantly or disappeared completely, then she/he will continue to follow you and watch your tumor to make sure that it continues shrinking until it disappears, or that it continues to stay away if it has disappeared. This is called non-operative management. During the endoscopic exam your surgeon may be uncertain whether the tumor has disappeared or not. He/she may decide to take a biopsy to see if there are cancer cells left.

Group 2: Consolidation Neoadjuvant Chemotherapy (CNCT) - Chemoradiation before chemotherapy

  • Chemoradiation: You will start by having approximately 6 weeks of chemoradiation therapy. Along with the radiation you will receive either 5-FU or capecitabine. Chemotherapy is given by an infusion into your vein.
  • Exam after chemoradiation: Approximately 2-6 weeks after completing chemoradiation therapy, you will have a digital rectal exam, an endoscopic exam (looking into your rectum) called a proctoscopy or flexible sigmoidoscopy, and an MRI to monitor your tumor is recommended but not required.
  • If your surgeon discovers that your tumor has increased in size then you will be treated according to standard practice.
  • If your tumor has remained stable (same size) or decreased in size, then you will continue with study treatment.
  • Chemotherapy: If you continue with trea
A Phase Ill Randomized, Double-Blind Placebo Controlled Study of Armodafinil {Nuvigil") To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma
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: The purpose of this study is to:

  • See if taking the study agent, Nuvigil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
  • See the effects {good and bad) of taking Nuvigil compared to placebo {an inactive agent) on cancer related fatigue.

Armodafinil (Nuvigil") is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue. In this study, Nuvigil/ or placebo will be given after you complete radiation and surgery for your cancer. We will use a computer to randomly assign you to one of the three study groups. Random assignment means that you are put into a group by chance like drawing numbers out of a hat. Your study group assignment will determine the treatment you will receive. Neither you nor the study investigator can choose the group you will be in. You will have a one in three chance of being placed in any group.

  • group 1, you will take a dose of the Nuvigil {150 mg) by mouth, every day in the morning. You will take this every day for 8 weeks.
  • group 2, you will take a dose of the placebo pill {inactive ingredient) by mouth, every day in the morning. You will take this every day for 8 weeks.
  • group 3, you will take a dose of the Nuvigil {250 mg) by mouth, every day in the morning. You will take this every day for 8 weeks

You will be asked to take the study agent or placebo for 8 weeks and complete patient diary and quality of life surveys.

A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NALA) ER/PR positive or negative/HER2 positive Puma Nala
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PUMA-NER-1301: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting (NALA)

The purpose of this study is to test the safety and benefit of an experimental drug called neratinib, when given with an approved breast cancer drug called capecitabine. Although capecitabine is an approved drug for use alone or in combination with other cancer drugs, the combination of neratinib and capecitabine is investigational. Researchers will measure if this combination is the same or better at preventing further progression of the breast cancer when compared to another treatment combination of lapatinib and capecitabine. We will also measure if neratinib and capecitabine have any benefit in overall survival compared to the combination of lapatinib and capecitabine. This study is for women/men with HER2+ metastatic breast cancer (MBC) who have received at least 2 previous HER2-directed treatments for MBC. A computer will randomly put you in one of the study groups. You have a 50/50 chance of being placed into either group. Neither you nor your doctor can choose or know which group you will be in. This research study has two study treatment groups. Oral tablets are given in both groups in 21 day cycles.

  • Group 1: will get neratinib + capecitabine
  • Group 2: will get lapatinib + capecitabine

This is an open-label study, which means you will know which treatment arm you are on. After you are finished with the study treatment, your physician will follow you for 18 months. It is anticipated that you will be in the study for approximately 28 months total.

A Treatment of Unresectable Hepatocellular Carcinoma with TheraSphere
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The purpose of this HDE treatment protocol is to provide access to TheraSphere· treatment to patients with liver cancer who cannot be treated by surgical removal of the tumor.

This study uses a Humanitarian Device Exemption (HDE). A HDE is a medical device used to treat conditions that occur infrequently. TheraSphere is a medical device containing yttrium-90 (Y-90), which has been used to treat liver tumors with radiation. Y-90 is a radioactive material that emits beta particles that travel less than Y, inch in tissue. The Y-90 has been incorporated into very tiny glass beads (TheraSphere) that can be injected into the liver through the blood vessels that supply the liver. This allows a large local dose of radiation to be delivered to the tumor with less risk of side effects from radiation to other parts of the body or to healthy liver tissue.

All patients will be in one group and will be treated with TheraSphere.

After the final visit (30 days after last treatment), your doctor will direct further clinical care related to your liver cancer. Your study investigator will continue to communicate with your oncologist at least once a year for up to two years to review how you are doing.

Adenoma and Second Primary Prevention Trial SWOG 0820 (PACES)
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This study is for people with a history of Stage 0, I, II, or III colon cancer that has been treated with surgery alone (at least one year ago) or in combination with chemotherapy and who no longer have cancer.

The purpose of this study is to determine if eflornithine and sulindac, taken alone or in combination, can decrease the risk of high-risk adenomas (colorectal adenomas are tiny growths in the colon that may eventually lead to cancer) or second primary colorectal cancers in patients who have been previously treated for Stage 0, I, II, or III colon cancer. ("Second primary colorectal cancer" means a new colorectal cancer developing within the colorectum.)

The study drugs eflornithine and sulindac are tablets which are taken orally. Sulindac is commercially available but is not approved for this indication. Oral eflornithine is an investigational agent and not approved by the FDA.

You will be randomized into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can select which study group you will be in. You have an equal chance of being in either group. This is a double-blind study, which means neither you nor the study team will know to which of these study drug groups you are assigned.

There are four treatment groups: You will be randomly assigned to either Group 1, Group 2, Group 3 or Group 4:

Group 1:placebo eflorinthine & placebo sulindac

  • You will take two (light tan) eflornithine placebo tablets once a day and one (golden-yellow) sulindac placebo tablet once a day. Placebo tablets look identical to the eflornithine and sulindac tablets, but they do not contain any medication.

Group 2: eflorinthine & placebo sulindac

  • You will take two (light tan) eflornithine tablets once a day and one (golden-yellow) sulindac placebo tablet once a day. The placebo tablet looks identical to the sulindac tablet, but it does not contain any medication.

Group 3: placebo eflorinthine & sulindac

  • You will take two (light tan) eflornithine placebo tablets once a day and one (golden-yellow) sulindac tablet once a day. The placebo tablet looks identical to the eflornithine tablets, but they do not contain any medication.

Group 4: eflorinthine & sulindac

  • You will take two (light tan) eflornithine tablets once a day and one (golden-yellow) sulindac tablet once a day.

Aall study participants will be given a 3-month supply of study drugs along with an intake calendar where you will record the number of pills you take each day and any side effects.

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) Crizotinib in treating patients with stage IB-IIIA non-small cellllung cancer that has been removed by surgery and ALK fusion mutations (ALCHEMIST Treatment Trial) Erlotinib Hydrochloride in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery (ALCHEMIST Treatment Trial)
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This study is for people with Stage IB-IIIA, non-squamous, non-small cell lung cancer (NSCLC) that has or will be removed by surgery.

The purpose of this research study is to examine surgically removed tumors from lung cancer patient for certain genetic changes, and to possbily refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes.

A genetic test will be done to learn if your tumor has any of these genetic changes:

  • Genetic changes in ALK (this will be referred to as ALK)
  • Genetic changes in EGFR (this will be referred to as EGFR)

If your tumor is not found to have the genetic changes in ALK or EGFR, your doctor will provide you with other options for your care and you wil be followed for 5 years.

If your tumor has a genetic change in ALK, you may be eligible to participate in a treatment clinical trial called ALCHEMIST-ALK study (E4512), that will randomize you to receive either:

  • Group 1: standard treatment plus crizotinib (pill)
  • Group 2: standard treatment plus placebo (pill)

The purpose of the ALCHEMIST-ALK research study is to compare any good and bad effects of using the study drug, crizotinib (also known as XALKORI), after completion of surgery and, in some cases, after chemotherapy and/or radiation therapy for ALK-positive non-small cell lung cancer. The addition of crizotinib may help prevent your cancer from returning, but it could also cause side effects.

If your tumor has a genetic change in EGFR, you may be eligible to participate in a treatment clinical trial called ALCHEMIST-EGFR study (A081105), that will randomize you to receive either:

  • Group 1: standard treatment plus erlotinib (pill)
  • Group 2: standard treatment plus placebo (pill)

The purpose of the ALCHEMIST-EGFR study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug).

A placebo is a pill that looks like the study drug, but is inactive and does not contain the study drug. You will be randomized into one of the study groups described above. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups (ALK study if you have the ALK mutation or the EGFR study if you have the EGFR mutation). Neither you nor your study doctor can select which study group you will be in. You have an equal chance of being in either group. This is a double-blind study, which means neither you nor the study team will know to which study drug group you were assigned (active drug or the placebo).

All patients will be followed for 5 years.

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
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The purpose of this study is to examine lung cancer patients’ surgically removed tumors for certain genetic changes, and to possibly refer these patients to a treatment study with drugs that may specifically target tumors that have these genetic changes

This study is for patients whose lung cancer tumor has either been removed or will be removed by a surgeon. As part of your normal treatment, you may receive chemotherapy or radiation therapy to reduce the chance of the cancer coming back.

Today, therapy is not based on tumor genetic testing, but this trial is trying to see if tumor genetic testing would be helpful at guiding treatment in patients such as you. A genetic test will be done to learn if your tumor genetic changes in ALK or EGFR. ALK and EGFR are both proteins found on the surface of cells. If your tumor is found to have one of these genetic changes you may be invited participate on a trial that will look at drugs which may target tumors that have these specific genetic changes.

If your tumor is not found to have genetic changes in either ALK or EGFR in the initial screening, you will be followed for five years. If your tumor is positive for ALK or EGFR, you will be invited to participate in a treatment trial specific to this genetic change.

Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Category:

The purpose of this study is to compare any good and bad effects patients may have when treated with the standard treatment against patients who are treated with the standard treatment against patients who are treated with the standard treatment plus erlotinib (an investigational drug). For this specific type of lung cancer, after patients finish their chemotherapy (although some of them may receive radiation therapy) they are followed without additional therapy. A computer will by chance assign you to one of the treatment groups in the research study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. You will have an equal chance of being placed in either group. You and your doctor will not know which group you are assigned until you have completed treatment, unless needed for a medical emergency.

This research study has two study groups:

  • Group 1 will get the study drug, erlotinib. It will be taken once a day by mouth.
  • Group 2 will receive a placebo, a capsule that looks like the study drug but contains no medication. It will be taken once a day.

You will have treatment with erlotinib or placebo for up to 2 years, or until the tumor grows or you have bad side-effects. You will then see your study doctor every 6 months for the first 4 years after starting treatment, and then yearly for the following 6 years, for a total of 10 years.

Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery (NCCTG 1048)
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This study is for people with cancer of the rectum who have not yet had treatment.

The standard treatment for locally advanced rectal cancer involves chemotherapy and radiation, known as 5FUCMT, (the chemotherapy drugs 5-fluorouracil/capecitabine and radiation therapy) prior to surgery. Although radiation therapy to the pelvis has been a standard and important part of treatment for rectal cancer and has been shown to decrease the risk of the cancer coming back in the same area in the pelvis, some patients experience undesirable side effects from the radiation.

The purpose of this study is to compare the effects, both good and bad, of the standard treatment of chemotherapy and radiation to chemotherapy using a combination regimen known as FOLFOX, (the drugs 5-fluorouracil (5-FU), oxaliplatin and leucovorin) and selective use of radiation treatment, depending on response to the FOLFOX. The drugs in the FOLFOX regimen are all FDA (Food and Drug Administration) approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer.

You will be randomized into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can select which study group you will be in. You have an equal chance of being in either group. All of the study drugs used in both groups have been FDA-approved for the treatment of colorectal cancer.

There are two treatment groups: You will be randomly assigned to either Group 1 or Group 2.

Group 1: chemotherapy & selective use of combination of chemotherapy and radiation therapy before or after surgery.

  • You will receive FOLFOX chemotherapy once every two weeks. On the first day of the cycles (Day 1), you will be given leucovorin and oxaliplatin through a catheter placed in a vein in your arm (intravenously or IV) for 2 hours and also 5- fluorouracil IV via continuous infusion. This is one cycle; you will receive 6 cycles total over a period of 12 weeks.
  • After completing FOLFOX chemotherapy, you will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor and how it has changed. If the tumor has decreased in size by at least 20% from before you started chemotherapy, you will proceed directly to surgery. If the tumor has not shrunk in size by 20%, you will receive radiation with chemotherapy. This is exactly the same treatment that will be given to the patients in Group 2.
  • A pathologist will study the tumor removed during surgery using a microscope. If all borders of the tumor are normal and do not contain any tumor, this means that all the tumor could be removed during surgery and it is recommended that you receive six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal and contain some small amount of tumor, this means that the entire tumor could not be removed during surgery, and it is recommended that you receive chemotherapy and radiation therapy for 5.5 weeks after your surgery. The chemotherapy and radiation therapy that you will receive if all of the tumor could not be removed is exactly the same treatment that will be given to the patients in Group 2. After 5.5 weeks of chemoradiation (5FUCMT), additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks.

Group 2: preoperative chemotherapy and radiation therapy with additional chemotherapy after surgery

  • You will receive chemotherapy and radiation therapy for 5.5 weeks. You will be given either 5-fluorouracil IV via continuous infusion or Capecitabine doses taken orally twice daily, 5 days per week, on days of planned radiation therapy.
  • After the chemotherapy and radiation therapy is completed, you will proceed directly to surgery.
  • After surgery, it is recommended that you receive FOLFOX chemotherapy once every two weeks. On the first day of the cycles (Day 1), you will be given leucovorin and oxaliplatin IV for 2 hours and also 5-fluorouracil IV by continuous infusion. This is one cycle; you will receive 8 cycles total over a period of 16 weeks. The FOLFOX chemotherapy is the same as for Group 1. What is different is the timing and when it is given – before or after surgery.
Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer (GOG 0274)
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This study is for women with stage IB1 with positive nodes, IB2, II, IIIB or IVA squamous cell, adencocarcinoma or adenosquamous cell carcinoma of the cervix.

The purpose of this study is to compare standard treatment, radiation therapy combined with the chemotherapy drug cisplatin (chemo-radiation), to standard chemo-radiation therapy plus additional experimental chemotherapy with FDA approved agents carboplatin and paclitaxel to see if it reduces the risk of tumor recurrence in the pelvis and other places and if it improves overall survival.

Radiation Therapy is a treatment consisting of powerful x-rays that kill cancer cells. The chemotherapy in this study are drugs given into your vein to stop the growth of cancer cells by killing them or by stopping them from multiplying.

One group will receive standard chemo-radiation alone, whereas the other group will receive standard chemo-radiation and then additional chemotherapy.

You will be randomized into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. You have an equal chance of being in either group. Neither you nor your study doctor can select which study group you will be in.

There are two treatment groups: You will be randomly assigned to either Group 1 or Group 2.

Group A: Control Arm
You will receive chemo-radiation (standard radiation therapy plus cisplatin chemotherapy) only. This means you will receive standard external radiation therapy daily for five weeks. Following external radiation, intracavitary radiation (radiation delivered directly to the cervix through the vagina) will be administered. Depending on the type of intracavitary treatment administered, you may receive 1-5 intracavitary placements. The administration of cisplatin will take approximately 30-60 minutes each time. The radiation therapy will be given over eight weeks. The cisplatin chemotherapy will be given in five treatments, weekly during the course of the radiation therapy.

Group B: Intervention Arm
You will be given treatment that involves more than the standard treatment for this type of cancer. Side effects and quality of life information will be compared with the standard arm. This group will receive chemo-radiation (standard radiation therapy plus cisplatin chemotherapy), followed by carboplatin and paclitaxel chemotherapy. This means you will receive standard external radiation therapy daily for five weeks. Following external radiation, intracavitary radiation (radiation delivered directly to the cervix through the vagina) will be administered. Depending on the type of intracavitary treatment administered, you may receive 1-5 intracavitary placements. The administration of cisplatin will take approximately 30-60 minutes each time. The radiation therapy will be given over eight weeks. The cisplatin chemotherapy will be given in five treatments, weekly during the course of the radiation therapy. Within 4 weeks of finishing your radiation treatment, you will start to receive additional chemotherapy called carboplatin and paclitaxel. These two drugs will be given on one day, repeated every 3 weeks for 4 total cycles. Chemotherapy with carboplatin and paclitaxel takes about 6 hours to infuse each time.

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