All studies
Active not recruitingPHASE2INTERVENTIONAL

Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

This study is for people in the UK with stage 2 or 3 rectal (bowel) cancer. It explores different treatment approaches using radiation and chemotherapy before surgery. The aim is to find out if these pre-surgery treatments can shrink the tumour, potentially making the surgery more effective and reducing the amount of healthy tissue that needs to be removed. Researchers are also looking at how long a break between chemotherapy/radiation and surgery affects recovery and results. They will compare various combinations and timings of commonly used cancer drugs like fluorouracil, leucovorin, and oxaliplatin with radiation therapy. This is a Phase 2 study, which means it's testing if these approaches are effective and safe.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
Memorial Sloan Kettering Cancer Center
Enrolment target
248
Start
01 Aug 2008
Estimated completion
01 Dec 2026

What is this study about?

This research study is looking at the best ways to treat stage 2 or 3 rectal cancer before surgery. Rectal cancer is a type of bowel cancer. The main idea behind this study is to use a combination of treatments – radiation therapy and chemotherapy – before an operation. Radiation therapy uses high-energy X-rays to target and kill cancer cells. Chemotherapy uses special medicines that either kill cancer cells or stop them from growing and dividing. You might hear these medicines called drugs like fluorouracil, oxaliplatin, and leucovorin.

The hope is that by giving these treatments before surgery, the cancer tumour will shrink. If the tumour is smaller, it might make the surgery easier for doctors, leading to a more successful operation. It could also mean that less healthy tissue needs to be removed during surgery. The study is also trying to understand if giving chemotherapy and radiation with different breaks before surgery affects how well the treatment works and how easy the surgery is.

This is a 'Phase 2' study. This means that researchers are trying to see if these treatment approaches are effective and identify any immediate benefits or side effects. They are carefully checking how well the body responds to the treatment and how safe it is for patients. The ultimate goal is to improve the way we treat rectal cancer, aiming for better results for patients in the future.

Key takeaways

  • This study is for adults with stage 2 or 3 rectal (bowel) cancer.
  • It combines radiation and chemotherapy before surgery to potentially shrink tumours.
  • Researchers are testing different timings and combinations of medicines.
  • The goal is to improve surgical outcomes and patient recovery.
  • You will receive close medical monitoring throughout the study.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with stage 2 or stage 3 rectal cancer. Your cancer must be within 12 cm of the opening of your bottom (anus) and doctors need to confirm the exact stage using special scans like an Endorectal Ultrasound (ERUS) or MRI.

There are certain health conditions that mean you wouldn't be able to join. For example, if your cancer has spread to other parts of your body, or if you've had similar cancer in the same area before. You also couldn't join if you have certain heart conditions, uncontrolled seizures, or other serious brain or nerve problems. You also cannot be allergic to any of the chemotherapy drugs used in the study.

If you have a history of inflammatory bowel disease, a specific inherited condition called Familial Adenomatous Polyposis, or if you've had radiation treatment to your pelvis before, you wouldn't be able to participate. Your doctor will carefully review all your health information to understand if this study might be a good fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with Stage 2 or Stage 3 rectal adenocarcinoma?
  3. Is your tumour located within 12 cm of your anal opening?
  4. Have you *not* had previous radiation treatment to your pelvis?
  5. Do you have a general good level of health for your age?
  6. Do you *not* have cancer that has spread to other parts of your body?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a combination of radiation therapy and chemotherapy. You'd receive radiation therapy once a day, five days a week, for five weeks. Alongside this, you'd have the chemotherapy drug fluorouracil given into a vein continuously for about six weeks. After finishing these initial treatments, there would be a pause of at least four weeks.

Depending on which study group you are assigned to, you might then receive additional chemotherapy (called modified FOLFOX-6) before your surgery. This would involve a combination of different drugs given into a vein over a couple of days, repeated every two weeks for either two or four cycles. After these treatments, you would then have your standard surgery to remove the cancer. Throughout the study, you'll have regular hospital visits for assessments, blood tests, and scans to monitor your health and how the treatment is working. The total time you'd be involved in the active treatment and surgery part of the study would vary depending on your assigned group, but it typically involves several weeks of treatment before surgery.

Potential risks and benefits

Taking part in this study could potentially offer benefits like a smaller tumour before surgery, which might lead to a more successful operation. You would also receive close medical attention and monitoring. However, there are potential risks, as radiation and chemotherapy drugs can have side effects, such as sickness, tiredness, and hair loss. There could also be side effects from new drug combinations or timings. You have the right to withdraw from the study at any time without giving a reason, and this would not affect your standard medical care.

Locations (15)

  • Cancer Care Center at John Muir Health - Concord Campus
    Verified postcode
    Concord, United States
  • City of Hope Medical Center
    Verified postcode
    Duarte, United States
  • St. Joseph Hospital Regional Cancer Center - Orange
    Verified postcode
    Orange, United States
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
    Verified postcode
    Orange, United States
  • UCSF Helen Diller Family Comprehensive Cancer Center
    Verified postcode
    San Francisco, United States
  • Washington Cancer Institute at Washington Hospital Center
    Verified postcode
    Washington D.C., United States
  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    Verified postcode
    Tampa, United States
  • University of Chicago Cancer Research Center
    Verified postcode
    Chicago, United States
  • Masonic Cancer Center at University of Minnesota
    Verified postcode
    Minneapolis, United States
  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    Verified postcode
    St Louis, United States
  • Colon and Rectal Surgery, Incorporated
    Verified postcode
    Omaha, United States
  • Cleveland Clinic Taussig Cancer Center
    Verified postcode
    Cleveland, United States

Common questions

What does a 'Phase 2' study mean?

A Phase 2 study means researchers are testing if a new treatment or approach is working well and if it's safe for patients, often after earlier smaller studies have shown promise.

What is rectal cancer?

Rectal cancer is a type of cancer that starts in the rectum, which is the last part of your large bowel.

Will I know which treatment group I'm in?

Yes, in this type of study, you and your doctors will know exactly which treatment plan you are receiving.

What are chemotherapy and radiation therapy?

Chemotherapy uses medicines to kill cancer cells, and radiation therapy uses high-energy X-rays to destroy cancer cells.

Can I stop participating in the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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