AuthorisedPhase II and Phase III (Integrated)Interventional

TOTAL NEOADJUVANT TREATMENT WITHOUT SURGERY FOR LOCALLY ADVANCED RECTAL CANCER: PROSPECTIVE CLINICAL TRIAL TO ASSESS TUMOR COMPLETE RESPONSE, CIRCULATING TUMOR GENETIC AND EPIGENETIC BIOMARKERS, AND STROMAL TRANSCRIPTOME TO INTERPRET CLINICAL OUTCOME (NO-CUT TRIAL)

This study, called NO-CUT, is for adults with locally advanced rectal cancer. It's investigating a treatment approach that uses specific chemotherapy medications (Oxaliplatin and Capecitabine) without immediate surgery. The main aim is to see how well this treatment works at keeping the cancer from coming back in other parts of the body for at least two and a half years. Researchers will also be studying tiny bits of genetic material and other markers from the tumour to understand why some treatments work better for certain people. This helps us learn more about tailoring treatments in the future and could potentially reduce the need for surgery for some patients.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

ASST Grande Ospedale Metropolitano Niguarda

Enrolment target

180

Start

05 Aug 2024

Adenocarcinoma of the medium/lower rectum in Stage II (cT3-4 N0) or Stage III (cT1-4

What is this study about?

This clinical trial, known as NO-CUT, is for people in the UK who have locally advanced rectal cancer. This means the cancer has grown into the wall of the rectum or possibly spread to nearby lymph nodes, but hasn't spread to distant parts of the body. The study is exploring a new way of treating this type of cancer, focusing on a combination of chemotherapy drugs given before any potential surgery, and in some cases, aiming to avoid surgery altogether.

The main idea behind this study is to see if a strong course of chemotherapy can completely get rid of the cancer in some patients. If this happens, it could mean that surgery, which often has significant side effects, might not be needed for everyone. Researchers are particularly interested in how long patients remain free from the cancer spreading to other parts of their body after this treatment.

Beyond simply looking at how well the treatment works, the study will also analyse very small genetic and biological markers from the cancer. These markers can give doctors clues about how individual tumours respond to treatment. By understanding these markers better, we hope to develop more personalized and effective treatments for rectal cancer in the future, potentially helping doctors decide who might benefit most from this non-surgical approach.

Key takeaways

This study explores chemotherapy before surgery for locally advanced rectal cancer.
It aims to see if some patients can avoid surgery altogether.
Researchers will study genetic markers to understand treatment responses.
The main goal is to prevent cancer from returning elsewhere for at least 2.5 years.
Participants will receive specific chemotherapy drugs and regular monitoring.
It's open to adults aged 18 and over with specific types of rectal cancer.

Who may be eligible?

To be considered for this study, you would typically need to be an adult, aged 18 or older, with no upper age limit. The study is open to both men and women.

The type of cancer being studied is a specific kind called adenocarcinoma, located in the middle or lower part of the rectum. Your cancer would be classified as either 'Stage II' (meaning it has grown into the wall of the rectum but not spread to lymph nodes) or 'Stage III' (meaning it has grown into the wall and/or spread to nearby lymph nodes).

If you have other serious health conditions or your cancer has already spread to distant parts of your body, you would likely not be able to join this particular trial. A doctor on the study team would carefully review your medical history to see if it's 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.

Are you 18 years old or older?
Do you have adenocarcinoma in the middle or lower part of your rectum?
Has your doctor told you your cancer is 'Stage II' (cT3-4 N0) or 'Stage III' (cT1-4, N1-2)?
Has your cancer NOT spread to distant parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would primarily receive treatment with two chemotherapy drugs: Oxaliplatin and Capecitabine. These would be given according to a specific schedule outlined by the study doctors. You would have regular visits to the hospital or clinic to receive your treatments, undergo physical examinations, and have blood tests and scans.

Over time, your doctors would closely monitor how your cancer is responding to treatment using various tests. The study plans to follow participants for a period, with a key check-up at two and a half years, to see if the cancer has stayed away. You would also be asked to complete questionnaires about your quality of life, which helps understand how the treatment affects your daily living. The total duration of your participation would involve the treatment period and follow-up appointments.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available, and close monitoring by medical experts. This trial aims to see if certain patients can avoid surgery, which could improve quality of life. However, like all medical treatments, there are potential risks, mainly side effects from the chemotherapy drugs. These can vary from person to person and will be fully explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is 'locally advanced rectal cancer'?

This means your cancer is in the rectum and has grown into its wall or nearby lymph nodes, but hasn't spread to other distant parts of your body.

What are Oxaliplatin and Capecitabine?

These are common chemotherapy drugs used to treat certain cancers like rectal cancer. They work by killing cancer cells.

Will I definitely avoid surgery if I join this trial?

The study aims to see if some patients can avoid surgery, but it's not guaranteed. Doctors will monitor how your cancer responds to treatment to make that decision.

What are 'biological markers'?

These are tiny bits of genetic material or other substances in your body that can give clues about your cancer and how well it might respond to treatment.

What does a 'Phase II and Phase III' trial mean?

An 'integrated' Phase II and III trial means it combines two stages of testing. Phase II checks if a treatment works and is safe, while Phase III compares it to existing treatments to confirm its effectiveness.