Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)

Centre Georges Francois Leclerc2 sites in 1 country15 target enrollmentDecember 22, 2016

ConditionsAdvanced Rectal Cancers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Rectal Cancers
Sponsor: Centre Georges Francois Leclerc
Enrollment: 15
Locations: 2
Primary Endpoint: Complete histological response rate
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 22, 2016

End Date

January 7, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Georges Francois Leclerc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy
•Tumor \<15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI
•Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy
•Operable Patient
•Age between 18 and 75
•OMS performance status 0-2
•No co-morbidity likely to prevent the delivery of treatment
•Adequate contraception for men, and for non-menopausal women
•Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL
•Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS, Alkaline phosphatase ≤ 1.5 LNS

Exclusion Criteria

•Remote metastasis
•Cancer not resectable
•Contraindication to capecitabine and its excipients
•Previous history of pelvic radiotherapy or previous chemotherapy
•History of inflammatory bowel or rectum disease
•History of angina pectoris monitored or myocardial infarction or heart failure
•Active active infection or other serious underlying condition that may prevent the patient from receiving treatment
•Other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma
•Patient already included in another therapeutic trial with an experimental molecule
•Pregnant woman, likely to be pregnant or nursing