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

Not Applicable

Completed

• Conditions: Advanced Rectal Cancers
• Interventions: Radiation: Preoperative chemo-radiation with IG-IMRT dose escalation

• Registration Number: NCT03200249
• Lead Sponsor: Centre Georges Francois Leclerc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-22
• Primary Completion: 2016-12-22
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-26
• Study First Posted: 2017-06-27
• Status Verified: 2020-01
• Study Completion: 2020-01-07
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Preoperative chemo-radiation with IG-IMRT dose escalation	1. - Treatment : concomitant preoperative radio-chemotherapy (during 5 weeks) Chimiotherapy: Capecitabine 1600 mg/m2/j ; 5/7 days during the 5 weeks of radiotherapy Radiotherapy 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. 2. - TME surgery (8 weeks after the end of treatment)

Primary Outcome Measures

Name	Time	Method
Complete histological response rate	at 8 weeks after inclusion	Absence of residual cancer cells on the final analysis of the tumor and lymph node

Secondary Outcome Measures

Name	Time	Method
Tolerance	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	Toxicity is assessed according to the NCI-CTCAE toxicity scale version 4.0

Trial Locations

Locations (2)

Centre Gf Leclerc; 🇫🇷 Dijon, France

CHRU de Besançon; 🇫🇷 Besançon, France