Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Rectal Neoplasms
About this trial
This is an interventional treatment trial for Rectal Neoplasms focused on measuring rectal, cancer, neoadjuvant, radiotherapy, chemotherapy, mesorectal, excision
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed rectal adenocarcinoma
- cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1
- Multidisciplinary tumor board decision for neoadjuvant treatment
- Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging
- Patient 18 to 80 years old
- General health condition status WHO 0-1
- Absence of co-morbidities that may affect treatment
- Neutrophils >1,500 / mm3, platelets >100,000 / mm3, hemoglobin> 10 g / dL, normal creatinine, and creatinine clearance> 50 mL / min
- Signed informed consent of the patient
Exclusion Criteria:
- Distant metastases
- Non-resectable cancer
- Contraindications for the administration of chemotherapy
- Previous pelvic radiotherapy or chemotherapy
- History of inflammatory bowel disorders
- History of angina, acute myocardial infarction or heart failure
- Active sepsis or systemic infection
- Untreated physical and mental disability
- Synchronous malignancy
- Pregnancy or breast-feeding
- Lack of compliance with the protocol process
- Non-granting of signed informed consent
Sites / Locations
- Department of Surgery, University Hospital of LarissaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy
The experimental group will receive the standard 5-week neoadjuvant chemoradiotherapy (CRT). Thereafter, all patients will commence consolidation chemotherapy. At the 6th week after the end of CRT, patients will undergo MRI re-staging: In case of non-response (mrTRG 5) they will be submitted immediately to surgery, and, subsequently, excluded from the trial. In case of response (mrTRG 2-4) they will receive consolidation chemotherapy for the whole waiting period between the end of CRT and surgery - 12 weeks.
The control group will receive the standard 5-week neoadjuvant chemoradiotherapy regimen. Six weeks after completion the patient will be re-staged with rectal MRI and depending on the response will be operated (TME): immediately in case of non-response (mrTRG 5) or after an additional 6-week delay (overall 12 weeks after the end of chemoradiotherapy) in case of partial response (mrTRG 2-4). Adjuvant chemotherapy will be, also, administered.