CTRI/2022/03/041068RecruitingPhase 2
SEQUENCING NEOADJUVANT CHEMOTHERAPY WITH SHORT COURSE RADIATION THERAPY IN LOCALLY ADVANCED RECTAL CANCER: A PHASE II RANDOMIZED STUDY [SPADE STUDY] - SPADE STUDY
Institutional Intramural Funds0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility 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
- •1) Patients with lower third rectum with sphincter involvement planned for sphincter preserving
- •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
Investigators
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