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RecruitingPHASE3INTERVENTIONAL

Randomised Study Evaluating Adjuvant Chemotherapy After Resection of Stage III Colonic Adenocarcinoma in Patients of 70 and Over

This research focuses on people aged 70 and older who have had surgery for Stage III colon cancer. Doctors often use chemotherapy after surgery to help stop the cancer from coming back, but it's not always clear which treatments are best for older patients, or if they benefit from chemotherapy at all. This study aims to find out if chemotherapy helps older patients live longer without their cancer returning, and which chemotherapy options are most effective and safest for them. Researchers want to understand if a simpler chemotherapy is enough, or if a stronger combination treatment is better for those who are fit enough, especially since bowel cancer is more common in older people.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Federation Francophone de Cancerologie Digestive
Enrolment target
774
Start
01 Jan 2015
Estimated completion
01 Aug 2025

What is this study about?

Bowel cancer, also known as colorectal cancer, is very common in older people. More than half of all cases happen in those aged 70 and over. When someone has Stage III colon cancer, it means the cancer has spread to nearby lymph nodes but not to distant parts of the body. After surgery to remove the cancer, doctors often suggest extra treatment called chemotherapy. This 'adjuvant' chemotherapy aims to kill any remaining cancer cells and reduce the chance of the cancer coming back.

However, it's not always straightforward for older patients. Sometimes, the chemotherapy that works well for younger people can have noticeable side effects in older adults. Previous studies haven't included many very elderly patients, so doctors aren't sure if the standard treatments are always the best choice for this age group, or if a gentler approach, or even no chemotherapy, might be better for some. There's also a question about whether a stronger chemotherapy, which combines different drugs, offers real benefits for older patients compared to a single drug treatment.

This study is trying to answer these important questions. It will compare different chemotherapy options, and in some cases, no chemotherapy, to see what helps older patients live longer without their cancer returning. The study carefully divides patients based on their overall health and how well they can cope with treatment, after a thorough check-up, including one with a specialist in older people's health (a geriatrician). By doing this, the researchers hope to find clearer guidance on the most effective and safest treatments for older people with Stage III colon cancer.

Key takeaways

  • This study explores the best chemotherapy for older people (70+) with Stage III colon cancer after surgery.
  • It aims to find out if chemotherapy helps them live longer without cancer returning, and which treatment is most effective.
  • Patients will be carefully assessed by a team of doctors, including specialists in older people's health.
  • Different chemotherapy drugs or combinations are being compared, and some may receive observation without chemotherapy.
  • The study addresses important questions about cancer treatment for an increasing number of older patients.

Who may be eligible?

To join this study, you must be 70 years old or older and have been diagnosed with Stage III colon cancer. You must have had surgery to remove your main tumour completely. Your doctors must also believe you are well enough to receive chemotherapy. You will need to start any potential chemotherapy within 12 weeks of your surgery.

There are also some reasons why you might not be able to join. For example, if you have another ongoing cancer that isn't under control, you won't be eligible. The study is specifically for colon cancer, so if your cancer is in your rectum (the very last part of your bowel), you can't take part. Also, if you have certain blood conditions, severe liver problems, or existing nerve damage (neuropathy) from previous treatments, you might be excluded, depending on which treatment group you are assigned to.

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 70 years old or older?
  2. Have you been diagnosed with Stage III colon cancer?
  3. Have you had surgery to completely remove your colon cancer?
  4. Are you able to start potential chemotherapy within 12 weeks of your surgery?
  5. Do you have a different progressive cancer that’s not under control?
  6. Is your cancer in your rectum (not your colon)?
Answer every question to see your result.

What does participation involve?

Taking part in this study would involve having a careful health check by a team of doctors, including a specialist in older people's health. Depending on your overall health, you would then be randomly assigned to one of several treatment groups. These groups might involve different types of chemotherapy (drugs like LV5FU2 or capecitabine, or a combination like FOLFOX4 or XELOX) or, in some cases, careful observation without chemotherapy. You would receive these treatments according to a set schedule, with regular check-ups to monitor your health and treatment effects. The total duration of your participation, including follow-up after treatment, would be over several years to track whether the cancer returns.

Potential risks and benefits

Participating in this study might offer the potential benefit of receiving the most effective treatment for your specific situation, based on careful assessment. However, like all medical treatments, chemotherapy can have side effects, which would be explained to you in detail. There's also the chance you might be assigned to a group that gets a treatment that doesn't work as well for you, or that you might experience side effects from taking part. You are always free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (140)

  • CHU de Fort de France
    Approximate
    Fort de France, France· Recruiting
  • CH d'Abbeville
    Verified postcode
    Abbeville, France· Recruiting
  • CROMG
    Verified postcode
    Agen, France· Recruiting
  • Centre hospitalier du Pays d'Aix
    Verified postcode
    Aix-en-Provence, France· Recruiting
  • Centre hospitalier d'Albi
    Verified postcode
    Albi, France· Recruiting
  • Clinique Claude Bernard
    Verified postcode
    Albi, France· Recruiting
  • Clinique Claude Bernard
    Verified postcode
    Albi, France· Recruiting
  • Centre Oncogard
    Verified postcode
    Alès, France· Recruiting
  • Hôpital Sud
    Verified postcode
    Amiens, France· Recruiting
  • ICO Site Paul Papin
    Verified postcode
    Angers, France· Recruiting
  • CHU d'Angers
    Verified postcode
    Angers, France· Recruiting
  • HOP Privé
    Verified postcode
    Annemasse, France· Recruiting

Common questions

What is Stage III colon cancer?

This means your bowel cancer has spread to nearby lymph nodes, which are small glands that are part of your body's immune system, but not to other distant organs.

What is 'adjuvant chemotherapy'?

It's extra chemotherapy given after surgery. The aim is to kill off any remaining cancer cells that might be left behind and reduce the risk of the cancer coming back.

Why is this study only for people aged 70 and over?

Bowel cancer is more common in older people, but it's not always clear which chemotherapy treatments are best and safest for this age group. This study aims to find clearer answers.

What are the different treatments being tested?

The study compares different chemotherapy drugs like LV5FU2 or capecitabine, and combinations like FOLFOX4 or XELOX. Some participants might also be in a group that receives close monitoring without chemotherapy.

Will my health be checked carefully before I join?

Yes, you'll have a thorough health assessment, including a review by a specialist in older people's health (a geriatrician), to make sure the study and any treatments are suitable for you.

How to find out more

Martina Schneider

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

Interested in taking part?

Register your interest

Share your details and the research team for "Randomised Study Evaluating Adjuvant Chemotherapy After Rese…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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