Study on Managing Locally-Advanced Rectal Cancer with Oxaliplatin, Fluorouracil, and Irinotecan Hydrochloride for Patients Responding Well to Initial Chemotherapy

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What is this study about?

This clinical trial is focused on studying the treatment of rectal cancer, a type of cancer that affects the last part of the large intestine. The study aims to evaluate a personalized approach to managing this disease after a positive response to initial chemotherapy. The treatment involves several medications, including Oxaliplatin, Fluorouracil, Irinotecan Hydrochloride, Capecitabine, and Calcium Folinate. These medications are commonly used in chemotherapy, which is a treatment method that uses drugs to kill cancer cells.

The purpose of the study is to assess whether a less intensive treatment strategy can be effective for patients who respond well to initial chemotherapy. The study will be conducted in two phases. In the first phase, the focus is on ensuring that the cancer can be surgically removed with a high success rate. In the second phase, the study will look at maintaining the current rate of patients remaining free from cancer for three years. Participants will receive treatment over a period of up to 12 months, with some medications given as infusions, which means they are delivered directly into the bloodstream, and others taken orally as tablets.

Throughout the study, various aspects will be monitored, such as the rate of successful surgeries, the ability to preserve the anal sphincter, and the overall response to treatment. The study will also evaluate the quality of life of participants, including digestive, urinary, and sexual functions, using questionnaires. The safety of the chemotherapy treatments will be assessed using a standard scale to ensure that any side effects are carefully managed. The study is expected to continue until November 2030, with the aim of providing valuable insights into the management of rectal cancer.

1 induction chemotherapy

Receive a combination of medications to treat rectal cancer. These medications include oxaliplatin, fluorouracil, irinotecan hydrochloride, capecitabine, and calcium folinate.

Medications are administered through infusion or taken orally as prescribed by the healthcare provider.

2 evaluation of response

Undergo assessments to determine the response to the induction chemotherapy.

The evaluation includes imaging tests to check for tumor regression and ensure no evidence of metastatic disease.

3 de-escalation treatment strategy

If a favorable response is observed, a tailored treatment strategy is implemented.

This strategy aims to maintain a satisfactory surgical outcome while minimizing treatment intensity.

4 surgery

Undergo surgery to remove the tumor, ensuring a clear margin around the tumor site.

The goal is to achieve an R0 resection, which means no cancer cells are found at the outer edge of the tissue removed.

5 post-surgery follow-up

Participate in regular follow-up appointments to monitor recovery and check for any signs of cancer recurrence.

Follow-up includes assessments of quality of life, urinary and sexual function, and digestive health.

6 long-term monitoring

Continue to be monitored for up to three years to evaluate disease-free survival and overall survival rates.

Regular check-ups and tests are conducted to ensure no recurrence of cancer.

Who Can Join the Study?

  • The patient must have rectum cancer.
  • The patient should show a tumor shrinkage of 60% or more, and the CRM (a margin around the tumor) should be at least 1mm.
  • There should be no clear signs of cancer spread to other parts of the body on a CT-Scan (a type of detailed imaging test).
  • The patient should be in a general health condition that allows for major surgery in the pelvic area and treatment with a medication called Capecitabine.
  • The patient must have normal blood, liver, kidney, and electrolyte (ionogram) functions, checked within 7 days before starting the study treatment.
  • The study is open to both male and female participants.
  • The study is not specifically for vulnerable populations, meaning it is not designed for groups like children or those unable to consent.

Who Cannot Join the Study?

  • Patients who have not responded well to the initial treatment called neoadjuvant chemotherapy (NACT). This is a type of cancer treatment given before the main treatment to shrink a tumor.
  • Patients who cannot achieve a satisfactory R0 resection rate. This means the surgery cannot remove all visible cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centr Georges Francois Leclerc Dijon France
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Hopital Saint Antoine Paris France
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Europeen Marseille Marseille France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Hopital Beaujon Clichy France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Hospitalier De Pau Pau France
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Amupxsxuuh Pejghcze Hpmouylx Da Mlazrqsat Marseille France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
26.11.2021

Trial locations

Induction Chemotherapy is a treatment given to shrink a tumor before the main treatment, which is usually surgery. In this trial, it is used for patients with locally-advanced rectal carcinoma to see if they respond well to the chemotherapy before considering other treatment options.

Rectal Cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:
2024-511609-44-00
Protocol code:
PROICM 2021-01 GRE
NCT ID:
NCT04749108
Trial Phase:
Therapeutic use (Phase IV)

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