A Phase 3 interventional study of Surgery after 11 weeks of delay after chemoradiotherapy. and Surgery after 7 weeks of delay after chemoradiotherapy in Rectal Cancer, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-25.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
D0: Visit of inclusion and randomization After the end of chemoradiotherapy, the patient is seen in consultation by her / him a surgeon who propose him to participate in the study. At the end of the visit if the patient agrees to participate in it, the investigator at each center will conduct the collection of written consent to the inclusion of the patient. Inclusion will be recorded in the electronic Case Report Form (e-CRF) by the investigator at each center. Randomization (7 or 11 weeks of delay) is performed by the surgeon via the software module CleanWeb randomization.
M1- 1.5 or M2.5 depending of the group randomisation A consultation with the surgeon is held within 15 days (+/- 5 days) of intervention to check the clinical response (tumor regression in rectal tumor distance from the dentate line) and planify surgery. During this visit, the surgeon noted in the e-CRF, clinical findings of the lesion and the results of further investigations.
Not specific exam is requested in the study.
M2 or M3
Surgical procedure:
The anesthesia consultation is planned before the surgery according to the habits of service. Participation in the study does not alter the anesthetic procedures.The patient is admitted the day before surgery in the surgical ward.
During surgery, the operating data are provided on the e-CRF (digital rectal examination under general anesthesia, type of surgery (anterior resection or abdominal-perineal resection), operative time, intraoperative bleeding, macroscopic appearance of the mesorectum, distance from the distal limit of resection). The postoperative complications are noted by the surgeon in the e-CRF during hospitalization (about 10-15 days), and data reporting pathological (Annex 2).
Pathological examination of the specimen of proctectomy is performed according to recommendations for clinical practice using the standard form (Annex 2). The tumor response is evaluated by inclusion of all residual tumor and the response to chemoradiotherapy is graded with the scale of Rödel (Annex 5). A double reading of slides will be made for each patient by two independent pathologists blinded to the randomization group of the patient.
M2 - M5 or M3 - M6 :
Postoperative follow-up :
Following the intervention, no specific consultation is necessary. At follow-up consultations (1 month, 3 months) the surgeon evaluate the postoperative course, planify the stoma closure, noted the potential adverse events and results of morphological examinations (computed tomography, ultrasound, endoscopy) and biological (markers) eventually prescribed.
M6 - M60 :
Cancer surveillance :
Regular follow-up every 3-4 months fo the first two years and every 6 months for the last remaining 3 years (clinical examination, CT-scan and biological marker (CEA))
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 265 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The cessation of chemotherapy during radiotherapy does not exclude the patient from the study.
Exclusion Criteria:
The cancer surgery is practice 11 weeks after neoadjuvant radio-chemotherapy
Procedure: Surgery after 11 weeks of delay after chemoradiotherapy.
The cancer surgery is practice 7 weeks after neoadjuvant radio-chemotherapy
Procedure: Surgery after 7 weeks of delay after chemoradiotherapy
Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 11 weeks of delay after the end of chemoradiotherapy.
Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 7 weeks of delay after the end of chemoradiotherapy
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
Time frame: 6 month
Rates of clinical response to radio-chemotherapy before surgery, comparison between the two groups (7 versus 11 weeks)
Time frame: 6 month
Rate of tumor regression, comparison between the two groups (7 versus 11 weeks)
Time frame: 6 month
Rates of operative mortality and morbidity at 90 days, comparison between the two groups (7 versus 11 weeks)
Time frame: 6 month
Quality of mesorectum resection, comparison between the two groups (7 versus 11 weeks)
Time frame: 6 month
Rate of sphincter preservation, comparison between the two groups (7 versus 11 weeks)
Time frame: 6 month
Local and distant recurrence rates, comparison between the two groups (7 versus 11 weeks)
Time frame: 5 years
Overall survival and disease-free survival rates, comparison between the two groups (7 versus 11 weeks)
Time frame: 5 years
Functional results (LARS score)
LARS questionnaire (Low Anterior Resection Syndrome questionnaire) completed at 24 months and 36 months
Time frame: 24 months and 36 months
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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