Comparison between 5 days of radiotherapy followed by chemotherapy with 25 days of radiotherapy with daily oral chemotherapy in locally advance rectal cancer

Comparison of Overall Response to Neoadjuvant Short Course Radiotherapy Followed by Consolidation Chemotherapy with Long Course Chemoradiotherapy in Locally Advanced Rectal Cancer - Nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058369

Enrollment

Registered

2023-10-05

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C20- Malignant neoplasm of rectum

Interventions

Intervention1: Short course radiotherapy followed by consolidation chemotherapy: Radiation-Total 25 Gy is delivered in 5 fractions of 5Gy each over 1 week. Neoadjuvant chemotherapy -chemotherapy will

Eligibility

Inclusion criteria

Inclusion criteria: Ecog ps > 1, previously untreated biopsy proven rectal adenocarcinoma, locally advanced tumor fulfilling at least one of the following criteria on pelvic mri/cect_ct3-t4, node positive, mesorectal fascia involvement, metastatic lateral lymph node, extra mural vascular invasion, adequate blood counts, adequate renal function, adequate hepatic functions.

Exclusion criteria

Exclusion criteria: a.Evidence of recurrence /distant metastasis(M1). b. Patient who received prior treatment for rectal cancer. c. Concurrent uncontrolled medical condition. d. Pregnant/breast feeding. e. Active Crohn’s disease or ulcerative colitis. f. Synchronous malignancies.

Design outcomes

Primary

Measure	Time frame
To compare the clinical, radiological and metabolic response rates between of patients receiving Short Course Radiotherapy (SCRT) followed by chemotherapy and conventional long course CRT.Timepoint: Week 12-13 of treatment.	—

Secondary

Measure	Time frame
To compare the rates of pathological complete response between groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. To assess the Disease-Free Survival between groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. To compare the rates of radiation toxicities in groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. To compare the rates of post-operative complications in groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. Timepoint: 1.5YEARS	—

Measure

Time frame

To compare the rates of pathological complete response between groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. To assess the Disease-Free Survival between groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. To compare the rates of radiation toxicities in groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. To compare the rates of post-operative complications in groups of patients receiving SCRT followed by chemotherapy and conventional long course CRT. Timepoint: 1.5YEARS

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Countries

India

Contacts

Public ContactDr Sushmita Pathy

All India institute of medical sciences,New Delhi

drspathy@gmail.com9811898793

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026