Adaptive Radiation in Anal Cancer

• Status: Recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a 20 patient pilot study to examine the feasibility of dose-adapted radiation therapy for the treatment of locally advanced anal squamous cell cancer. The tumor and a patient's anatomy may change during radiation treatment and daily adaption of the radiation plan (i.e., a new daily plan based on the anatomy of the day) may help to maximize the dose to the tumor and minimize the radiation dose to the normal surrounding organs.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Varian
• Treatments: Capecitabine; Fluorouracil; Mitomycin; Mitomycins

Criteria

Inclusion Criteria:

• Histologically proven, invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal.

• American Joint Committee on Cancer (AJCC) 8th edition stage T2 > 4 cm, T3-4 or N1.

• Age ≥18 years.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%).

• Life expectancy of greater than 12 months.

• Patients must have normal organ and marrow function as defined below:

• leukocytes greater than or equal to 3,000/microliter

• absolute neutrophil count greater than or equal to 1,500/microliter

• platelets greater than or equal to 100,000/microliter

• total bilirubin within normal institutional limits

• Aspartate transaminase (AST)(SGOT)/Alanine transaminase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal

• creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

• Females of childbearing potential and males must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of study therapy. All pregnancies must be reported.

• Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Prior or co-existing invasive malignancy (except non-melanomatous skin cancer) unless disease free ≥ 2 years.

• Prior chemotherapy or radiation for anal cancer.

• Patients who have undergone complete surgical resection.

• Presence of recurrent/metastatic disease.

• Prior allergic reaction to 5-Fluorouracil or mitomycin C.

• Artificial organ prosthetics, pacemakers or other implantable devices.

• Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields.

• Uncontrolled inter-current illness including but not limited to known history of HIV with cluster of differentiation 4 (CD4) count less than 200 or symptomatic cardiac disease.

• Women who are pregnant or lactating.