AI-Powered daily radiation adjustments aim to improve anal cancer treatment
NCT ID NCT05838391
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests whether using artificial intelligence to adjust radiation plans daily can better target tumors while sparing healthy organs in people with locally advanced anal cancer. Twenty participants will receive standard radiation over six weeks, but each day's plan is adapted based on that day's anatomy. The study primarily looks at whether this approach is practical and how long it takes, while also tracking side effects and tumor response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Adaptive radiotherapy (AI-guided daily radiation plan adjustments)
- What this could lead to
- If successful, this approach could make radiation therapy more precise, potentially reducing side effects and improving tumor control for anal cancer patients.
- What could go wrong
- This is a very small pilot study with only 20 participants, so results may not apply broadly. The main focus is on feasibility, not yet on effectiveness, and daily adaptive planning may increase treatment time or complexity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2023
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anal squamous cell carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a global patient registry improve anal cancer care for people with HIV?
- Can a shorter radiation course beat anal cancer?
- Can an immunotherapy drug boost the power of chemoradiation against anal cancer?
- Can anal cancer treatment spare sexual well-being? a study tracks the toll over two years.
- Drug combo aims to shrink Hard-to-Treat anal cancer
- Less invasive surgery shows promise for anal cancer in HIV patients