Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers

Last updated: June 23, 2020
Sponsor: Centre Georges Francois Leclerc
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Rectal Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT03200249
2016-A01083-48
  • Ages 18-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis

Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommendspreoperative radiochemotherapy

  2. Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI

  3. Tumor potentially resectable from the outset, or considered to be resectable afterradiochemotherapy

  4. Operable Patient

  5. Age between 18 and 75

  6. OMS performance status 0-2

  7. No co-morbidity likely to prevent the delivery of treatment

  8. Adequate contraception for men, and for non-menopausal women

  9. Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL

  10. Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS,Alkaline phosphatase ≤ 1.5 LNS

  11. Creatinine clearance> 50 mL / min

  12. Patient must have been informed and must have signed the specific informed consentform.

  13. Patient must be affiliated to a Social Health Insurance.

Exclusion

Exclusion Criteria:

  1. Remote metastasis

  2. Cancer not resectable

  3. Contraindication to capecitabine and its excipients

  4. Previous history of pelvic radiotherapy or previous chemotherapy

  5. History of inflammatory bowel or rectum disease

  6. History of angina pectoris monitored or myocardial infarction or heart failure

  7. Active active infection or other serious underlying condition that may prevent thepatient from receiving treatment

  8. Other concomitant cancer, or history of cancer other than in situ cancer of thetreated cervix or basal cell carcinoma or squamous cell carcinoma

  9. Patient already included in another therapeutic trial with an experimental molecule

  10. Pregnant woman, likely to be pregnant or nursing

  11. Persons deprived of their liberty or under guardianship

  12. Patient unable to comply with the required medical follow-up for geographic, social orpsychological reasons

Study Design

Total Participants: 15
Study Start date:
December 22, 2016
Estimated Completion Date:
January 07, 2020

Connect with a study center

  • CHRU de Besançon

    Besançon, 25030
    France

    Site Not Available

  • Centre Gf Leclerc

    Dijon, 21000
    France

    Site Not Available

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