Study comparing preoperative drug combination with irinotecan, fluorouracil, calcium folinate and oxaliplatin for patients with locally advanced resectable rectal cancer

3 1 1 1

What is this study about?

This study focuses on patients with locally advanced resectable rectal cancer located in the middle or lower part of the rectum. The research aims to compare two different treatment approaches: using chemotherapy alone versus using chemotherapy followed by combined chemotherapy and radiation therapy before surgery.

The treatment involves several medications given through intravenous infusion, including irinotecan hydrochloride, calcium folinate, fluorouracil, and oxaliplatin. These medications are commonly used to treat various types of cancer and work together to stop or slow down the growth of cancer cells.

During the study, patients will receive treatment over multiple cycles. The effectiveness of the treatment will be monitored for three years after the start of treatment to determine how well it prevents the cancer from returning or spreading. The study will help determine if chemotherapy alone can be as effective as the combination of chemotherapy and radiation therapy in treating this type of rectal cancer.

1 Initial treatment phase

You will receive preoperative chemotherapy through intravenous infusion. The medications used include:

Irinotecan hydrochloride

Calcium folinate

Fluorouracil

Oxaliplatin

2 Treatment continuation

Based on your assigned treatment group, you may receive either:

– Continued chemotherapy alone, or

– Chemotherapy combined with chemoradiotherapy (radiation therapy with chemotherapy)

3 Surgical procedure

After completing the preoperative treatment, a surgical procedure will be performed to remove the rectal tumor

4 Follow-up period

Your progress will be monitored for 3 years after starting the treatment

Regular medical examinations will be conducted to assess your health status

The study will continue until December 2030

5 Health monitoring requirements

If you are of reproductive age, you must use effective birth control during treatment and for 6 months after the last treatment

Your overall health status should remain stable, with a performance status of 0 or 1 on the WHO/ECOG scale

Who Can Join the Study?

  • Confirmed rectal cancer located in the middle or lower part of the rectum, within 12 cm from the anal opening (confirmed by MRI scan)
  • Cancer staging must be either:
    T3N0 (tumor has grown through the bowel wall but hasn’t spread to lymph nodes) or
    T1-T3N+ (tumor of varying size that has spread to nearby lymph nodes)
  • The tumor margin must be more than 2mm from surrounding tissues on MRI scan
  • Age 18 or older
  • Performance status of 0 or 1 (meaning you must be either fully active or restricted only in strenuous activities)
  • Must sign an informed consent form
  • If able to have children, you must agree to use effective birth control during treatment and for 6 months after the last treatment

Who Cannot Join the Study?

  • Previous treatment with chemotherapy or radiation therapy for rectal cancer
  • Presence of distant metastases (cancer that has spread to other parts of the body)
  • Pregnancy or breastfeeding women
  • Severe heart, kidney, or liver disease that could interfere with treatment
  • Active infections requiring treatment
  • Known allergies to study medications
  • Other active cancers within the past 5 years (except for adequately treated non-melanoma skin cancer)
  • Mental conditions that could affect ability to provide informed consent
  • Inability to undergo MRI examination
  • Participation in other clinical trials within 30 days before starting this study
  • History of inflammatory bowel disease
  • Major surgery within 4 weeks before starting the study
  • Immunodeficiency (weakened immune system) or ongoing immunosuppressive therapy
  • Uncontrolled comorbidities (other medical conditions) that could affect study participation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif 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
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Antoine Lacassagne Nice France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Nimes Nimes France
Clinique Tivoli Ducos Bordeaux France
Groupement De Cooperation Sanitaire Risssa Recherche & Innovation Sante Sarcelles Sarcelles France
IHFB Cognacq Jay Levallois-Perret France
Hopital Prive Jean Mermoz Lyon France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Simone Veil De Beauvais Beauvais France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Institut Sainte Catherine Avignon France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Centre Francois Baclesse Caen France
Igployev Rflhtjth Dw Cacuci Dl Meozynbasja Montpellier France
Clcxfu Lekr Bbcaal Lyon France
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Ipgkotrf Mtmuwfxtwi Mnviidwgne Paris France
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Cyscng Hxrwwmxgrab Ujowmjwgzuudo Dq Dqjql Dijon France
Afgiaubrvz Pdeuoyst Hwwokgsp Dx Munayppnk Marseille France
Bwedxbtu Uclqcwhlvy Haytturr Cicjtd Besançon France
Cgiznw Hwdyvnlyowc Rrtrxwwf Ugwosmibvxvnd Dd Tnjki Tours France
Cfuu Do Nunoj Vandoeuvre Les Nancy France
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Irwijnts Pgonlzmhftplscy Cwrums Cuwxyc Marseille France
Hyeobkbn Ucakvdemdaerzq Stxcivlama &loaxrn Hnserrs dr Hwkgoohplrv 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
05.06.2019

Trial locations

Chemotherapy
This is a treatment that uses powerful medications to kill cancer cells throughout the body. In this trial, it’s used before surgery to treat locally advanced rectal cancer. The chemotherapy works by targeting and destroying rapidly dividing cells, including cancer cells.

Chemoradiotherapy
This is a combined treatment that uses both chemotherapy and radiation therapy together. The chemotherapy medications are given along with radiation treatment to make cancer cells more sensitive to radiation. This combination therapy is commonly used in treating rectal cancer before surgery.

Investigated diseases:

Rectal Carcinoma – A cancer that develops in the tissues of the rectum, which is the last part of the large intestine. The disease typically begins as small growths called polyps that can become cancerous over time. As the cancer progresses, it can grow through the layers of the rectal wall and potentially spread to nearby tissues. In middle and low locally advanced cases, the tumor has grown into the deeper layers of the rectal wall but remains in a potentially operable area. The condition may involve nearby lymph nodes but has not spread to distant parts of the body.

Trial ID:
2024-510580-28-00
NCT ID:
NCT03875781
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

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  • Study of XELOX chemotherapy with or without dostarlimab after chemoradiation in patients with locally advanced rectal cancer

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