Rectal Neoplasms Clinical Trial
Official title:
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
NCT number | NCT05496491 |
Other study ID # | NCCCRC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 30, 2022 |
Est. completion date | August 30, 2025 |
The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | August 30, 2025 |
Est. primary completion date | August 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Surgery, University Hospital of Larissa | Larissa |
Lead Sponsor | Collaborator |
---|---|
Larissa University Hospital |
Greece,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Free Survival | Occurence of Disease Free Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 3 years postoperatively | |
Secondary | Complete Pathological Response | Occurence of Complete Pathological Response. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Postoperative Complication | Occurence of postoperative complications based on the Clavien Dindo Classification. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Length of Hospital Stay | Postoperative time that the patient can be safely discharged. Measurement unit: days. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria | Maximum time frame 39 days postoperatively | |
Secondary | Readmission | Occurence of postoperative readmission. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Negative Resection Margin | Occurence of Negative Resection Margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 1 month postoperatively | |
Secondary | Overall Survival | Occurence of Overall Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 3 years postoperatively | |
Secondary | Chemotherapy Toxicity | Occurence of Chemotherapy Toxicity. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 3 years postoperatively | |
Secondary | Local Recurrence | Occurence of Local Recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 3 years postoperatively | |
Secondary | Treatment Compliance | Occurence of Treatment Compliance. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO' | 3 years postoperatively |
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