Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: NIL: NIL
Sponsors
MNJ institute of oncology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed rectal adenocarcinoma on endoscopic biopsy 2. Clinical stage cT3 or cT4 any N, OR cT2 with node positive disease, confirmed by high resolution pelvic MRI, with M0 confirmed on CT chest abdomen and pelvis 3. Lower tumour border within 15 cm of anal verge 4. Planned for and receiving sequential induction oxaliplatin based chemotherapy NACT followed by concurrent chemoradiotherapy NACT-RT followed by total mesorectal excision TME 5. ECOG Performance Status 0 to 2 6. Adequate organ function: Haemoglobin 9 g per dL or above; ANC 1500 per microlitre or above; Platelets 100000 per microlitre or above; Creatinine clearance 50 mL per min or above; Bilirubin 1.5 times ULN or below; AST and ALT 3 times ULN or below 7. Baseline CEA and CA19-9 blood tests available within 7 days of NACT Cycle 1 Day 1 8. Written informed consent obtained in the patient preferred language 9. Able to attend all 9 study visits and provide all 6 study blood draws
Exclusion criteria
Exclusion criteria: 1. Synchronous distant metastasis (M1 disease) 2. Mucinous adenocarcinoma with more than 50 percent mucinous component, or signet ring cell carcinoma with more than 50 percent signet ring cell component (CEA secretion unreliable in these histological subtypes) 3. Prior pelvic radiotherapy 4. Prior active malignancy within 5 years, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ 5. Known DPD (dihydropyrimidine dehydrogenase) deficiency 6. Active inflammatory bowel disease 7. Pregnancy or lactation 8. Anticipated inability to complete 4 or more of the 6 required study blood draws 9. Participation in another interventional clinical trial testing a treatment modification
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop and internally validate a nomogram using serial NCR values at 6 timepoints across the NACT followed by NACT-RT course to predict pathological complete response (pCR: ypT0N0) in the TME resection specimenTimepoint: T0 Baseline T1 NACT early T2 NACT mid T3 NACT completion / CRT baseline T4 CRT Week 3 T5 CRT completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlate NCR parameters with Modified Ryan Scheme for Tumor Regression Score (TRG 0 3Timepoint: post surgery;Correlate NCR parameters with ypT/ypN downstagingTimepoint: post surgery TME specimen;Compare nomogram C-index of NCR vs CEA alone, CA19-9 alone, TMI, and STBC scoreTimepoint: post surgery;Determine whether NACT-phase NCR change (T0 to T3) contributes independently to pCR prediction beyond CRT-phase change (T3 to T5)Timepoint: post surgery;Determine optimal NCR cutoffs at each timepointTimepoint: post surgery;CRM positivity rate and R0 resection rate by NCR trajectory classTimepoint: post surgery TME specimen | — |
Countries
India
Contacts
Public ContactDr Ravitej Athota
mnj institute of oncology
Outcome results
None listed