Study of CAPOX or FOLFOX chemotherapy before surgery in patients with obstructive colon cancer treated with colostomy

3 1 1 1

What is this study about?

This clinical trial focuses on treating patients with obstructive colon cancer who have undergone initial treatment with a temporary opening in the abdomen (stoma) to relieve the blockage. The study aims to determine if giving chemotherapy before surgery can improve treatment outcomes compared to giving chemotherapy after surgery.

The treatment involves different combinations of chemotherapy medications including oxaliplatin, fluorouracil, capecitabine, and levoleucovorin. These medications are given either as tablets taken by mouth or as solutions administered through a vein. The chemotherapy combinations used in this study are known as CAPOX and FOLFOX.

The treatment period lasts up to 6 months, during which patients receive regular doses of chemotherapy medications. Throughout the study, patients will need to undergo various medical examinations and tests to monitor their health and response to treatment. The success of the treatment will be measured by how many patients can complete the entire planned treatment sequence.

1 Initial assessment

After confirmation of colon cancer that blocks the intestine, a temporary opening (stoma) will be created to relieve the blockage

Medical tests will be performed to confirm eligibility, including blood tests and CT scan of chest, abdomen, and pelvis

Laboratory tests must show adequate blood cell counts, liver function, and kidney function

2 Treatment assignment

You will be assigned to receive one of two chemotherapy combinations:

Option 1 (CAPOX): Oxaliplatin by injection plus Capecitabine tablets

Option 2 (FOLFOX): Oxaliplatin, Fluorouracil, and Levoleucovorin by injection

3 Pre-surgery chemotherapy

Chemotherapy will be given before the main surgery to remove the cancer

Regular monitoring of your health status will be performed during treatment

Monthly pregnancy tests are required for women of childbearing potential

4 Surgery

Surgery will be performed to remove the affected part of the colon

The temporary stoma may be closed during this procedure if appropriate

5 Follow-up period

Regular check-ups will continue after surgery

Women must use birth control during treatment and for 15 months after completion

Men must use birth control during treatment and for 12 months after completion

Who Can Join the Study?

  • Must be at least 18 years old
  • Must have good physical performance status (ECOG 0 or 1 – able to carry out normal activities with minimal symptoms)
  • Must have been treated with a defunctioning stoma (temporary opening in the abdomen to relieve bowel obstruction) for obstructive colon cancer
  • Must have confirmed adenocarcinoma (type of cancer) located at least 10 cm from the anal opening
  • Must need surgery to remove part of the colon
  • Must meet specific blood test requirements, including:
    • Adequate white blood cell and platelet counts
    • Acceptable hemoglobin levels
    • Normal liver and kidney function tests
  • Must have cancer that has not spread to other parts of the body (non-metastatic)
  • Must not have a second colon cancer
  • Must not have had previous chemotherapy or radiation to the abdomen or pelvis
  • Must not have had previous colorectal cancer
  • Must not have serious medical conditions that could interfere with treatment
  • Women who can become pregnant must use effective contraception during treatment and for 15 months after
  • Men must use contraception during treatment and for 12 months after
  • Must be able to follow study requirements
  • Must have health insurance
  • Must provide informed consent

Who Cannot Join the Study?

  • Age under 18 or over 75 years old
  • Presence of distant metastases (cancer spread to other parts of the body)
  • Previous chemotherapy or radiation therapy for colon cancer
  • Presence of other active cancers (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
  • Severe heart conditions including:
    • Uncontrolled high blood pressure
    • Unstable heart disease
    • Heart attack within past 6 months
  • Severe kidney dysfunction
  • Severe liver dysfunction
  • Active, uncontrolled infection
  • Known allergy to any of the study medications
  • Pregnancy or breastfeeding
  • Inability to follow study procedures
  • Participation in another clinical trial within the past 30 days
  • Mental conditions that could interfere with study participation or consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Colmar Colmar France
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Centre Hospitalier Universitaire De La Reunion St Denis France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Hopital Ambroise Pare Boulogne-Billancourt France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Hopital Huriez Lille France
Centre Hospitalier De Pau Pau France
Centre Hospitalier De Saint-Denis St Denis France
Ctkjnh Hkajxtezhfv Ukdzlvzntykfb Rcosw Reims France
Cdtofo Hrngefcgflg Ez Uxsjjnxrzhsou Dp Lfphllc Limoges France
Cdugdn Hldhujbxnjn Ugcnzrznqwoed Dl Dyqgk Dijon France
Axnseukule Punmxwsk Hskxqcbr Dv Pujyp Paris France
Amtpxdxowk Pzxinsmg Hndtlask Dd Mlicnrxrr Marseille France
Bnnnxtre Udxakrihfm Hmjcpcmq Czhucd Besançon France
Cycmtz Hbbyljechhn Rczlaxvh Uqnjpsrqycqiy Dh Tsawz Tours France
Cyba Dk Njkam Vandoeuvre Les Nancy France
Hfdmblkk Umydbzlwxzrpkb Sqdnpvspex &bdxytz Hamrhvv df Hrenfwleymm STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
07.05.2024

Trial locations

CAPOX
A combination chemotherapy treatment that includes capecitabine and oxaliplatin. This medication is used to treat colon cancer before surgery (neoadjuvant therapy). It is taken partly as tablets and partly through an intravenous infusion.

FOLFOX
A combination chemotherapy treatment that includes fluorouracil, leucovorin, and oxaliplatin. This medication is used to treat colon cancer before surgery (neoadjuvant therapy). It is given through an intravenous infusion over several hours.

Both these treatments are standard chemotherapy combinations used in colorectal cancer treatment, with the main difference being how they are administered to patients. They work by stopping or slowing down the growth of cancer cells.

Investigated diseases:

Colorectal Cancer (Obstructive) – A form of cancer that develops in the large intestine (colon), specifically characterized by a tumor that blocks the normal passage of contents through the colon. The blockage typically develops gradually as the tumor grows inward from the colon wall. This condition can cause the colon to become distended above the blockage. The disease begins when healthy cells in the colon develop changes in their DNA and grow uncontrollably, forming a mass. As the tumor increases in size, it can eventually narrow the intestinal passage to the point of obstruction.

Trial ID:
2024-516456-17-00
Protocol code:
2019/0407/HP
NCT ID:
NCT06107920
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study of inavolisib, letrozole and ribociclib in untreated early-stage breast cancer patients with PIK3CA mutation

    Recruiting

    2 1 1 1
    Investigated diseases:
    Germany Spain
  • Study of Dostarlimab for Patients with Untreated Stage III Resectable Colon Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium