Clinical trial · Interventional
IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer
Phase III Randomised Control Trial of Intensity-Modulated Radiotherapy Using Photon Versus Proton With Concurrent Chemotherapy for Locally Advanced Anal Canal 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 standard practice in management of carcinoma of anal canal is to treat patients with radiotherapy using the IMRT technique along with chemotherapy. It is known that while IMRT has reduced treatment related side effects as compared to the older radiation techniques, reducing these side effects further still remains a major challenge. These side-effects include gastrointestinal (diarrhea, altered bowel habits, weight loss, bleeding, obstruction), genitourinary (difficulties in passing urine, passing blood in urine, difficulty in holding urine) and hematologic toxicities (anemia, low platelet count and increased predisposition to infections). Proton therapy (IMPT) is a form of radiation treatment in which high doses can be delivered within the tumor while the surrounding normal tissues receive a lesser radiation dose. It is believed that these physical properties of proton therapy may help reduce the side effects of treatment. Patients will be randomly assigned to either receive IMRT or IMPT based treatment so as to see whether it is possible to reduce the acute treatment related toxicities. In this study, there is a 66.7% chance that the patient will get IMPT based treatment, which may be able to reduce the toxicities.
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 |
|---|---|---|---|
| Malignant Neoplasm of Anal Canal | Malignant Anal Canal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMPT (Intensity Modulated Proton Therapy) | Radiation | — | UNRESOLVED |
| IMRT (Intensity Modulated Radiation Therapy) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radical CTRT with IMPT (Intensity Modulated Proton Therapy)
- description
- Patients randomized to proton therapy arm will receive radiotherapy with IMPT technique along with concurrent chemotherapy for a duration 6-8 weeks.
- interventionNames
- Radiation: IMPT (Intensity Modulated Proton Therapy)
- type
- ACTIVE_COMPARATOR
- label
- Radical CTRT with IMRT (Intensity Modulated Radiation Therapy)
- description
- Patients randomized to photon arm will receive radiotherapy with IMRT technique along with concurrent chemotherapy for a duration 6-8 weeks.
- interventionNames
- Radiation: IMRT (Intensity Modulated Radiation Therapy)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 and \< 80 years of age 2. Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum 3. The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition) 4. Involvement of lower para-aortic lymph nodes (till renal hilum) as the only site of disease extension on PET CECT may also be included as they receive radical chemoradiation as standard treatment. 5. WHO or ECOG performance status 0-1 6. HIV testing is known and HPV (P16) testing done on tissue sample. 7. With suitable blood test values for standard concurrent chemotherapy (Hb \> 10 mg/dL, ANC \> 1.5 cells/mm3, Platelets \> 100,000 cells/mm3, Creatinine \< 1.5 x ULN, Bilirubin \< 3 x ULN, ALT \< 3 x ULN) as deemed by a medical oncologist in team. 8. The patient must be expected to tolerate the treatment and be compliant for follow up. 9. No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc. 10. Willing to consent to participate in the study. Exclusion Criteria: 1. Two or more synchronous primary cancers. 2. When prosthetic materials (e.g. hip prostheses) are present close to the target volume, it must be considered if this may introduce uncertainties in dose calculations, which may affect the treatment planning process. 3. Ulcerative colitis or any other histologically confirmed inflammatory bowel disease. 4. Poor reliability for follow-up and treatment completion.
References
Publications (0)
Data not yet available