Clinical trial · Interventional
Adaptive Radiation in Anal Cancer
Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma
NCT05838391CI-TRIAL-00102309recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Squamous Cell Carcinoma | Anal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-Fluorouracil | Drug | Fluorouracil | ALIAS |
| Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery | Radiation | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Mitomycin-C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chemotherapy and Adaptive Radiation Treatment Planning
- description
- Subjects will receive concurrent chemotherapy and radiation as part of their treatment for anal cancer. Subjects will receive standard of care 54 Gy of radiation, 5 days a week for 6 weeks. In addition, subjects will receive standard of care chemotherapy, with mitomycin C (10mg/meters squared IV on Day 1) and 5-Fluorouracil (1000mg/meters squared via IV on days 1-4 and 29-32) or capecitabine (825 mg/meters squared in two divided doses by mouth on days of radiotherapy).
- interventionNames
- Radiation: Artificial Intelligence Guided Daily Radiotherapy Treatment Planning and Delivery
- Drug: Mitomycin-C
- Drug: 5-Fluorouracil
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Time to plan and deliver treatment fractions.
- timeFrame
- Up to 6 weeks
- description
- This is defined by the time the first cone beam computed tomography to the end of treatment delivery for each treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.