Phase II Clinical Trial of KORTUC (KRC-01) Combined with Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach (K-BOOST)
This research is looking into a new treatment approach for people with locally advanced rectal cancer, specifically a type called stage III rectal adenocarcinoma. The study is called K-BOOST and focuses on combining a new drug, KRC-01, with standard radiotherapy. The main aim is to find out if this combination can lead to a *complete tumour response*, meaning the cancer shrinks away completely, potentially allowing patients to avoid surgery and preserve the affected organ. This is a Phase II trial, meaning it's still in the early stages of testing for effectiveness and safety. Researchers are also looking at long-term survival, how long people stay cancer-free, and any side effects, along with quality of life during treatment.
At a glance
What is this study about?
This clinical trial, called K-BOOST, is investigating a new way to treat locally advanced rectal cancer. Rectal cancer is a type of cancer that starts in the rectum, which is the final part of the large intestine. 'Locally advanced' means the cancer has grown into nearby tissues but hasn't spread to distant parts of the body. The specific type of cancer this study is looking at is called 'stage III rectal adenocarcinoma,' which is considered high-risk.
Currently, some patients with rectal cancer might have surgery to remove the affected part of the bowel. This study is exploring if combining a new experimental drug, KRC-01, with radiotherapy can effectively shrink the cancer to the point where surgery might not be needed. This is known as an 'organ preservation approach,' which aims to save the rectum and potentially improve a patient's quality of life by avoiding the need for a stoma (an opening created in the abdomen to divert waste).
The main goal of this study is to see how many patients achieve a 'clinical complete response' after 24 weeks. This means that doctors cannot find any remaining signs of the cancer after treatment. Researchers will also be looking at other important factors, such as overall survival (how long people live), progression-free survival (how long people live without their cancer growing or coming back), and the impact on a patient's quality of life. They will also be closely monitoring for any side effects of the treatment and trying to understand how the drug works in the body.
Key takeaways
- This study is testing a new drug (KRC-01) with radiotherapy for rectal cancer.
- The main goal is to see if this combination can make cancer disappear, potentially avoiding surgery.
- It's for specific types of locally advanced, high-risk rectal cancer.
- Researchers will monitor safety, effectiveness, and quality of life.
- This is an early-stage (Phase II) trial.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 or over. This study is open to both men and women.
Importantly, this trial is specifically for people who have been diagnosed with 'locally advanced high-risk stage III rectal adenocarcinoma.' This means your rectal cancer has grown into nearby tissues but has not spread to other parts of your body. Your doctor will be able to confirm if your specific type of cancer fits this description.
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.
- Are you 18 years old or older?
- Do you have locally advanced, high-risk stage III rectal adenocarcinoma?
- Has your cancer not spread to distant parts of your body?
- Are you able to commit to regular hospital visits and assessments?
What does participation involve?
If you join this study, you would receive the new drug KRC-01 alongside standard radiotherapy. You would have regular visits to the hospital for treatment, check-ups, and to complete questionnaires about your health and how you're feeling. These visits would include blood tests, scans (like PET scans and other imaging), and potentially biopsies to help the researchers understand how the treatment is working and monitor for any side effects. You would also be asked to answer questions about your quality of life. The study involves a detailed follow-up plan to monitor your health and any long-term effects of the treatment. The total duration for active treatment and follow-up can vary, but generally involves assessments at specific time points like week 6 and week 24, with continued monitoring over a longer period.
Potential risks and benefits
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Common questions
What is KRC-01?
KRC-01 is a new, experimental drug being tested in this study. Researchers want to see how it works when given alongside standard radiotherapy for rectal cancer.
What does 'locally advanced' mean?
'Locally advanced' means the cancer has grown into nearby tissues but has not spread to other parts of your body.
What is 'organ preservation'?
Organ preservation means trying to treat the cancer effectively so that you might not need surgery to remove the affected part of your bowel, helping to maintain its normal function.
Will I still need radiotherapy?
Yes, in this study, the new drug KRC-01 is given *with* radiotherapy, not instead of it.
What does a 'complete response' mean?
A complete response means that doctors cannot find any signs of the cancer remaining after treatment, based on their tests and examinations.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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