Health Condition 1: D- Radiation Therapy
Conditions
Interventions
Intervention1: Long course chemoradiation followed by consolidation chemotherapy: Patient will receive 54 Gy external beam radiation along with Capecitabine (oral 825 mg/m2 twice daily) over a period
Sponsors
Cancer Institute WIA
Eligibility
Inclusion criteria
Inclusion criteria: Patients must fulfil all of the following criteria to be considered eligible: 1. Histologically confirmed adenocarcinoma of the rectum 0-8 cm from anal verge 2. Age 18-70 years 3. ECOG performance status 0-2 4. MRI staged LARC deemed to require neoadjuvant radiation- Stage II (T3, N0) or Stage III (T1-3, N1-3) 5. Potentially resectable (amenable to total mesorectal excision) 6. No prior treatment for rectal cancer (chemotherapy or surgery or radiation) 7. Absolute neutrophil count > 1.5 cell/mm3, Hemoglobin >8.0 gm/ dL, Platelets > 150,000/mm3, total bilirubin 9. Must have signed an informed consent form to participate in the study
Exclusion criteria
Exclusion criteria: Patients will not be eligible if they fulfil any of the following: 1. Presence of distant metastasis 2. Recurrent rectal cancer 3. Symptomatic bowel obstruction due to the tumor 4. Mucinous tumors or signet ring cell carcinoma 5. Familial adenomatous polyposis or hereditary non polyposis colorectal cancer 6. Have a contraindication for MRI e.g. non-MR compatible hip prosthesis, cardiac pacemaker 7. Patients who have received prior pelvic radiotherapy or have a contraindication to radiation 8. Patients who have any contraindication or hypersensitivity to the systemic chemo agents used in this study including but not limited to neuropathy, known DPD deficiency. 9. History of thrombotic arterial events eg. stroke, myocardial infarction in the last 12 months or clinically significant cardiac disease or left ventricular ejection fraction 10. Patients with any other concurrent uncontrolled medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study according to the investigatorâ??s judgement. 11. Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. 12. Patients receiving other anticancer or experimental therapy. 13. Patients who are pregnant, breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the proportion of complete or near complete responses- (near) cCR- in the two treatment armsTimepoint: 24 weeks from completion of (chemo) radiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference between the Organ preservation rates in the two armsTimepoint: 2 years from date of response assessment;Proportion of local regrowths in patients on NOM pathwayTimepoint: 2 years from date of response assessment;Disease-free survival of patients in the NOM pathwayTimepoint: 2 years from date of response assessment;Difference between the two arms in the frequency of Grade 3 or more adverse eventsTimepoint: During treatment- After completion of radiation & after each cycle of chemotherapy In patients on NOM pathway- at 12 & 24 months from response assessment.;Difference in the compliance to consolidation chemotherapy between the two armsTimepoint: From beginning of neoadjuvant treatment upto completion of (chemo) radiation.;Diagnostic performance of the pre-defined criteria for cCR and near cCR.Timepoint: From response assessment to 12 months from decision for NOM].;Difference between the two arms in the proportion of Grade 3 or more 30-day surgical complication measured by the Clavien-Dindo scoreTimepoint: From day of surgery till 30 days post-operative;Difference in the Health related quality of life- assessed by EORTC CR29 & CR30 between patients in the NOM pathway & those undergoing TMETimepoint: Time frame from randomisation till 2 years from response assessment;Difference between patients in the NOM pathway & those undergoing TME in bowel function [Timepoint: From randomisation till 2 years from response assessment | — |
Countries
India
Contacts
Public ContactRamakrishnan Ayloor Seshadri
Cancer Institute (WIA)
Outcome results
None listed