Clinical trial · Interventional
Influence of Lengthening the Interval Between Radiochemotherapy and Surgery on Complete Pathological Response in Rectal Cancer
Randomized Control Trial Comparing the Impact of a Lengthening of the Interval Between the Radiochemotherapy and Surgery (7 Weeks vs. 11 Weeks) on Complete Pathological Response in Rectal Cancer
NCT01648894CI-TRIAL-00059860GRECCAR6completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to planify the surgery. During this visit, the study will be explained them and their consent obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in this study does not change treatment, investigations and consultations usually necessary for management of rectal cancer. The objective is to improve the pathological complete response rate of the rectal cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery after 11 weeks of delay after chemoradiotherapy. | Procedure | — | UNRESOLVED |
| Surgery after 7 weeks of delay after chemoradiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 11 weeks
- description
- The cancer surgery is practice 11 weeks after neoadjuvant radio-chemotherapy
- interventionNames
- Procedure: Surgery after 11 weeks of delay after chemoradiotherapy.
- type
- OTHER
- label
- 7 weeks
- description
- The cancer surgery is practice 7 weeks after neoadjuvant radio-chemotherapy
- interventionNames
- Procedure: Surgery after 7 weeks of delay after chemoradiotherapy
Primary outcomes (1)
- measure
- Percentage of pathological complete response after pathological examination of surgical specimen defined by the absence of persistent tumor cell invasion and lymph node (ypT0N0) in group 7 weeks versus 11 weeks in the group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age over 18 years, no age limit higher * Performance status evaluated by the Eastern CooperativeOncology Group (ECOG) score: 0-1, * Patients with cancer of the middle or lower rectum (lesion located within 10 cm from the dentate line or 12 cm from the anal margin) proved by pathology, * T3-T4N0, TxN+ on ultrasound-endoscopy and MRI, without secondary localization (M0) on the thoracoabdominal (or chest radiography and abdominal ultrasound) * Patient who received a protocol between 45-51 Gy of radiotherapy and chemotherapy based on 5-fluorouracil for an average duration of 5 weeks for the management of rectal cancer, * Curative surgical treatment planned following radiochemotherapy with total mesorectal excision, * Free and informed consent signed by the patient, * Patient affiliated to a social security scheme or beneficiary of such plan(except AME) * Patient able, according to the investigator, to comply with the requirements of the study. The cessation of chemotherapy during radiotherapy does not exclude the patient from the study. Exclusion Criteria: * Patient with metastasis, * T1 or T2N0 tumor classified by echo-endoscopy and MRI, * rectal tumor with lower pole is more than 12 cm from the anal margin or 10 cm from the dentate line, * Patient did not complete the full protocol of radiotherapy, * History of tumors (other than basal cell carcinoma and / or carcinoma in situ of the cervix) old less than 10 years * A patient with impaired or incompetent investigator by not allowing him a good understanding of the requirements of the study, * Person under guardianship, persons under guardianship, persons deprived of their liberty by judicial or administrative body, adult subject to legal protection or unable to consent, * Patient did not complete the full protocole of chemotherapy, * Pregnant or lactating women.
References
Publications (2)
- DERIVEDLefevre JH, Mineur L, Kotti S, Rullier E, Rouanet P, de Chaisemartin C, Meunier B, Mehrdad J, Cotte E, Desrame J, Karoui M, Benoist S, Kirzin S, Berger A, Panis Y, Piessen G, Saudemont A, Prudhomme M, Peschaud F, Dubois A, Loriau J, Tuech JJ, Meurette G, Lupinacci R, Goasgen N, Parc Y, Simon T, Tiret E. Effect of Interval (7 or 11 weeks) Between Neoadjuvant Radiochemotherapy and Surgery on Complete Pathologic Response in Rectal Cancer: A Multicenter, Randomized, Controlled Trial (GRECCAR-6). J Clin Oncol. 2016 Nov 1;34(31):3773-3780. doi: 10.1200/JCO.2016.67.6049. PMID 27432930
- DERIVEDLefevre JH, Rousseau A, Svrcek M, Parc Y, Simon T, Tiret E; French Research Group of Rectal Cancer Surgery (GRECCAR). A multicentric randomized controlled trial on the impact of lengthening the interval between neoadjuvant radiochemotherapy and surgery on complete pathological response in rectal cancer (GRECCAR-6 trial): rationale and design. BMC Cancer. 2013 Sep 12;13:417. doi: 10.1186/1471-2407-13-417. PMID 24028546