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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Rectal Cancers
• Intervention / Treatment: Radiation: Preoperative chemo-radiation with IG-IMRT dose escalation

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHRU De Besancon
  • Dijon, France, 21000
    • Centre GF Leclerc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative 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 after radiochemotherapy
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 consent form.
13. Patient must be affiliated to a Social Health Insurance.

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 the patient from receiving treatment
8. Other concomitant cancer, or history of cancer other than in situ cancer of the treated 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 or psychological reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Treatment; - Treatment : concomitant preoperative radio-chemotherapy (during 5 weeks)Chimiotherapy: Capecitabine 1600 mg/m2/j ; 5/7 days during the 5 weeks of radiotherapyRadiotherapy RT + SIB-IMRT (5 weeks ; 5 sessions/week ; 25 sessions): Pelvic prophylactic dose of 45 Gy (1,8 Gy/session); "boost" with a dose of 60 Gy on the tumor PTV (2,4 Gy/session) - Total dose: 60 Gy in 25 sessions during 5 weeks.; - TME surgery (8 weeks after the end of treatment)

Radiation: Preoperative chemo-radiation with IG-IMRT dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete histological response rate	Absence of residual cancer cells on the final analysis of the tumor and lymph node	at 8 weeks after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tolerance	Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0	at 1, 2, 3, 4, 5 and 13 weeks after inclusion and at 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after surgery

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2016
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: dose escalation, chemo-radiation, rectum cancer, phase 2
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 2016-A01083-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No