Comparing Sequence of Radiation therapy and chemotherapy before surgery in Advanced Rectal cancer [SPADE STUDY]
- Conditions
- Health Condition 1: C20- Malignant neoplasm of rectum
- Registration Number
- CTRI/2022/03/041068
- Lead Sponsor
- Institutional Intramural Funds
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pathological complete response (ypT0N0) rateTimepoint: After Surgery
- Secondary Outcome Measures
Name Time Method -R0 resection rate, <br/ ><br>-Sphincter preservation rates <br/ ><br>-Acute and late toxicity assessment with CTCAE v5.0 (Common Terminology Criteria for <br/ ><br>Adverse Events). <br/ ><br>-3yr-DFS (Disease free survival) and 3yr-OS (Overall survival) <br/ ><br>-Disease progression during neoadjuvant therapyTimepoint: 3 years