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

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

NCT ID: NCT06630793

Condition: Malignant Neoplasm of Anal Canal

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
IMPT
IMRT
Anal canal

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: IMPT (Intensity Modulated Proton Therapy)
Description: 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.
Arm group label: Radical CTRT with IMPT (Intensity Modulated Proton Therapy)

Intervention type: Radiation
Intervention name: IMRT (Intensity Modulated Radiation Therapy)
Description: 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.
Arm group label: Radical CTRT with IMRT (Intensity Modulated Radiation Therapy)

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.

Criteria for 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. 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. 7. The patient must be expected to tolerate the treatment and be compliant for follow up. 8. No contradiction for chemoradiation such as inflammatory bowel disease, pregnancy, etc. 9. 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tata Memorial Centre

Address:
City: Mumbai
Zip: 400012
Country: India

Contact:
Last name: Rahul Krishnatry, MD

Phone: +91-22-24177028

Phone ext: 7028
Email: krishnatry@gmail.com

Investigator:
Last name: Rahul Krishnatry, MD
Email: Principal Investigator

Start date: October 2024

Completion date: May 1, 2032

Lead sponsor:
Agency: Tata Memorial Centre
Agency class: Other

Source: Tata Memorial Centre

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06630793