NCT05838391Recruiting
Adaptive Radiation in Anal Cancer
Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 4 Apr 2023
- Start date
- 18 May 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Columbia University
- NCT number
- NCT05838391
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 18 May 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Prior allergic reaction to 5-Fluorouracil or mitomycin C.
- Prior radiotherapy to the pelvis that would result in overlap of radiation therapy fields.
Other illness
- Presence of recurrent/metastatic disease.
Lab values
- 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.
Other
- Artificial organ prosthetics, pacemakers or other implantable devices.
- Women who are pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.