Clinical trial · Interventional
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are: * Is total neoadjuvant treatment in this design safe \& tolerable? * Impact of this design on treatment related outcomes in terms of pathological and clinical responses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Carcinoma | Rectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| short course radiation therapy followed by 6 cycles of CAPOX then surgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Short course RT followed by full course of chemotherapy then surgery
- description
- Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery.
- interventionNames
- Radiation: short course radiation therapy followed by 6 cycles of CAPOX then surgery
Primary outcomes (3)
- measure
- pathological complete response (pCR)
- timeFrame
- within 30 days
- description
- No residual disease in surgical specimen
- measure
- clinical complete response(cCR)
- timeFrame
- within 30 days
- description
- No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathological proof of rectal adenocarcinoma. * Tumors located within 15 cm and not less than 4 cm from anal verge. * Age: ≥ 18 years. * Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve). * ECOG Performance Status: 0-2. Exclusion Criteria: * Non-epithelial rectal malignancy such as sarcoma or lymphoma. * Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen. * Recurrent rectal cancer. * Previous history of malignancy within the last 5 years. * Previous pelvic irradiation. * Psychiatric or addictive disorder that would preclude study therapy. * Concurrent uncontrolled medical conditions. * Pregnancy or breast feeding. * Any contraindication to surgery. * Extensive peripheral neuropathy.
References
Publications (0)
Data not yet available