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

NCT06630793 | Recruiting

• 1 other identifier: 4336
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

IMPT; IMRT; Anal canal

Outcome Measures

Primary Outcomes (1)

• Grade 3 or higher acute toxicity

  The highest GI/GU/Hematological toxicity will be captured per patient will be documented using CTCAE v5.0 and the percentage of patients with more than Grade 3 toxicity will be added in each arm and compared proportionately.

  Upto 6 months post-last cytotoxic therapy.

Secondary Outcomes (8)

• Local Failure

  5 years since randomization

• Regional Failure

  5 years since randomization

• Distant Relapse

  5 years since randomization

• Colostomy-free Survival

  5 years since randomization

• Disease-free Survival

  5 years since randomization

Study Arms (2)

Radical CTRT with IMPT (Intensity Modulated Proton Therapy)

EXPERIMENTAL

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

Radiation: IMPT (Intensity Modulated Proton Therapy)

Radical CTRT with IMRT (Intensity Modulated Radiation Therapy)

ACTIVE COMPARATOR

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

Radiation: IMRT (Intensity Modulated Radiation Therapy)

Interventions

IMPT (Intensity Modulated Proton Therapy) 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 IMPT (Intensity Modulated Proton Therapy)

IMRT (Intensity Modulated Radiation Therapy) 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.

Radical CTRT with IMRT (Intensity Modulated Radiation Therapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 80 years of age
• Histologically confirmed squamous cell carcinoma of the anal canal or distal rectum
• The patients may have TNM stage T1-2 N+M0 or T3-4 N0-1c M0 (UICC 8th edition)
• 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.
• WHO or ECOG performance status 0-1
• HIV testing is known and HPV (P16) testing done on tissue sample.
• 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.
• The patient must be expected to tolerate the treatment and be compliant for follow up.
• No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc.
• Willing to consent to participate in the study.

You may not qualify if:

• Two or more synchronous primary cancers.
• 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.
• Ulcerative colitis or any other histologically confirmed inflammatory bowel disease.
• Poor reliability for follow-up and treatment completion.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Centre

Mumbai, Maharashtra, 400012, India

RECRUITING

MeSH Terms

Conditions

Anal Canal Carcinoma

Interventions

Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Dr Rahul Krishanatry, MD

CONTACT

02224177028; krishnatry@gmail.com

Dr Rahul Krishanatry, MD

CONTACT

02224177028; krishanatry@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: October 8, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2032
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)