Comparing two radiation therapies for anal canal cancer with chemotherapy

Phase III Randomised Control Trial of Intensity-Modulated Radiotherapy Using Photon Versus Proton With Concurrent Chemotherapy for Locally Advanced Anal Canal Cancer

This study is testing whether a new type of radiation therapy called proton therapy works better than standard radiation therapy for people with anal canal cancer who are also getting chemotherapy, while trying to reduce side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tata Memorial Centre (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Mumbai, Maharashtra)
• Trial ID: NCT06630793 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of Intensity Modulated Proton Therapy (IMPT) versus Intensity Modulated Radiation Therapy (IMRT) in patients with locally advanced anal canal cancer who are also receiving concurrent chemotherapy. The study will randomly assign participants to receive either IMPT or IMRT, with the goal of determining which method better reduces treatment-related side effects such as gastrointestinal and genitourinary toxicities. By leveraging the unique properties of proton therapy, the trial seeks to minimize damage to surrounding healthy tissues while effectively targeting the tumor. The trial will include patients aged 18 to 80 with specific cancer staging and performance status criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with histologically confirmed squamous cell carcinoma of the anal canal or distal rectum.

Not a fit: Patients with contraindications for chemoradiation, such as inflammatory bowel disease or pregnancy, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to reduced side effects and improved quality of life for patients undergoing treatment for anal canal cancer.

How similar studies have performed: Other studies have shown promise with proton therapy in reducing side effects in various cancers, suggesting potential success for this approach in anal canal cancer.

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.

Where this trial is running

Mumbai, Maharashtra

• Tata Memorial Centre — Mumbai, Maharashtra, India (Recruiting)

Study contacts

• Study coordinator: Dr Rahul Krishanatry, MD

Conditions Malignant Neoplasm of Anal Canal; IMPT; IMRT; Anal canal