IMRT Versus IMPT With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer

NCT ID: NCT06630793

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-18
• Study Completion Date: 2032-05-01

Brief Summary

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

Malignant Neoplasm of Anal Canal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radical CTRT with IMPT (Intensity Modulated Proton Therapy)

Patients randomized to proton therapy arm will receive radiotherapy with IMPT technique along with concurrent chemotherapy for a duration 6-8 weeks.

Group Type: EXPERIMENTAL

IMPT (Intensity Modulated Proton Therapy)

Intervention Type: RADIATION

Proton therapy is a form of radiation treatment in which high doses can be delivered within the tumour while relatively sparing the surrounding normal tissues. This may help further reduce the side-effects of radiation treatment observed with IMRT.

Radical CTRT with IMRT (Intensity Modulated Radiation Therapy)

Patients randomized to photon arm will receive radiotherapy with IMRT technique along with concurrent chemotherapy for a duration 6-8 weeks.

Group Type: ACTIVE_COMPARATOR

IMRT (Intensity Modulated Radiation Therapy)

Intervention Type: RADIATION

The standard management of carcinoma of the anal canal is radiotherapy using the IMRT technique along with concurrent chemotherapy. The use of IMRT has reduced the treatment-related side-effects as compared to older radiation techniques. However, further reducing these side effects poses a major challenge.

Interventions

IMPT (Intensity Modulated Proton Therapy)

Proton therapy is a form of radiation treatment in which high doses can be delivered within the tumour while relatively sparing the surrounding normal tissues. This may help further reduce the side-effects of radiation treatment observed with IMRT.

Intervention Type: RADIATION

IMRT (Intensity Modulated Radiation Therapy)

The standard management of carcinoma of the anal canal is radiotherapy using the IMRT technique along with concurrent chemotherapy. The use of IMRT has reduced the treatment-related side-effects as compared to older radiation techniques. However, further reducing these side effects poses a major challenge.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tata Memorial Centre

Mumbai, Maharashtra, India

Site Status: RECRUITING

Countries

India

Central Contacts

Dr Rahul Krishanatry, MD

Role: CONTACT

krishnatry@gmail.com

02224177028 ext. 7028

Dr Rahul Krishanatry, MD

Role: CONTACT

krishanatry@gmail.com

02224177028 ext. 7028

Facility Contacts

Rahul Krishnatry, MD

Role: primary

krishnatry@gmail.com

+91-22-24177028 ext. 7028

Other Identifiers

4336

Identifier Type: -

Identifier Source: org_study_id