Increasing dose of radiation in rectal cancer patientcan lead to better sustained tumour response and avoid surgery

Not Applicable

Conditions: Health Condition 1: C20- Malignant neoplasm of rectum

Registration Number: CTRI/2020/03/024184

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Clinical Stage T2-T3

-Histologically confirmed diagnosis of adenocarcinoma of the rectum

-The distance from anal verge of tumor upto 10 cm(Mid and low rectal tumors)

-Palpable upper limit

-Involving less than 2/3rd of the circumference

-ECOG Performance status 0-1

Exclusion Criteria

-Recurrent rectal cancer

-Having pathology of signet ring cell carcinoma

-Evidence of distant metastases

-Prior pelvic radiotherapy, chemotherapy or surgery for rectal cancer

-Creatinine level greater than 1.5 times the upper limit of normal.

-Patients who are unable to undergo an MRI.

-Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer.

-Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA.

-Other Anticancer or Experimental Therapy.

-Women who are pregnant or breast-feeding.

-Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.

-Not willing to consent for the study

-Unreliable for close follow up

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of complete or near complete clinical response rate of the primary rectal tumors at 12 weeks.Timepoint: 24 months

Secondary Outcome Measures

Name	Time	Method
-Organ Preservation Rate <br/ ><br>-Rate of local regrowth <br/ ><br>-Rate of disease-free and overall survival <br/ ><br>-Rate of patients without stoma at 2 years <br/ ><br>-Morbidity after chemoradiotherapy and brachytherapy related toxicity (assessed by CTCAE scoring V 5- acute within 3 months after treatment, late at 6 months, then 3 monthly Surgical morbidity <br/ ><br>-Quality of life assessment <br/ ><br>Timepoint: 24 months