Health Condition 1: C20- Malignant neoplasm of rectum
Conditions
Interventions
Intervention1: Arm 1 [Experimental Arm]: Neoadjuvant chemotherapy with either 6 cycles of CAPOX or 9 cycles
of mFOLFOX7 followed by Short Course RT followed by surgery.
Control Intervention1: Arm 2 [C
Sponsors
Institutional Intramural Funds
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed cancer of rectum 2) Patients with Age more than 18 years or less than 80 years. 3) With Adenocarcinoma, Adeno-squamous, or Signet ring cell histology. 4) Patients with disease arising upto 15cm from anal verge, and staged according to AJCC 8th edition TNM staging established on clinical and radiological imaging with: Tumor with invasion through muscularis propria into pericolorectal tissues with regional LN metastasis (TNM cT3 cN0-2 M0) Tumor with invasion in the visceral peritoneum or invasion/adherence to adjacent organ or structure, with or without regional LN metastasis (TNM cT4a/cT4b cN0-2 M0) 5) With ECOG performance status 0-2 6) Amenable for Curative Intent treatment. 6) Eligible for surgery 7) With Informed patient consent
Exclusion criteria
Exclusion criteria: 1) Patients with lower third rectum with sphincter involvement planned for sphincter preserving surgery. 2) Patients with upfront distant metastasis 3) Patients with recurrent disease 4) Patients who are unable to undergo MRI 5) Previous history of Abdominal or Pelvic radiotherapy 6) Severe medical condition impairing complete treatment delivery 7) Patients with immunocompromised states and psychological illness 8) Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (ypT0N0) rateTimepoint: After Surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| -R0 resection rate, -Sphincter preservation rates -Acute and late toxicity assessment with CTCAE v5.0 (Common Terminology Criteria for Adverse Events). -3yr-DFS (Disease free survival) and 3yr-OS (Overall survival) -Disease progression during neoadjuvant therapyTimepoint: 3 years | — |
Countries
India
Contacts
Public ContactAbhishek Shinghal
Tata Memorial Centre Varanasi
Outcome results
None listed