Adaptive radiation therapy for anal cancer
Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma
This study is testing a new way of giving radiation therapy that changes daily based on how the tumor responds, to see if it helps people with advanced anal cancer while protecting healthy tissue.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05838391 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of dose-adapted radiation therapy for patients with locally advanced anal squamous cell carcinoma. It involves 20 patients and focuses on daily adaptation of radiation plans based on changes in tumor size and patient anatomy during treatment. By utilizing advanced imaging techniques, the study seeks to maximize radiation delivery to the tumor while minimizing exposure to surrounding healthy tissues. The approach includes the use of chemotherapy agents alongside radiation therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed invasive anal squamous cell carcinoma that meets specific staging criteria.
Not a fit: Patients with non-squamous cell anal cancers or those with severe comorbidities that affect treatment tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized radiation treatment for patients with anal cancer, potentially improving outcomes and reducing side effects.
How similar studies have performed: While adaptive radiation therapy is an emerging approach, similar studies have shown promise in improving treatment outcomes in other cancer types, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lisa Kachnic, MD — Principal Investigator
- Study coordinator: Christina Chesnakov
- Email: cc4047@cumc.columbia.edu
- Phone: 646-317-4244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.