Precision proton beam aims to spare healthy tissue in anal cancer treatment
NCT ID NCT01858025
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested a newer, more precise form of proton radiation called pencil beam scanning, given alongside standard chemotherapy drugs (5-FU and mitomycin-C), for people with anal cancer. The goal was to see if this combination is practical and might cause fewer skin side effects than standard radiation. Twenty-five participants were enrolled to assess feasibility and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pencil beam scanning proton radiation with 5-fluorouracil and mitomycin-C
- What this could lead to
- If successful, this approach could offer a way to treat anal cancer with fewer side effects than standard radiation.
- What could go wrong
- This is a very early pilot study with only 25 people. It only tests feasibility, not effectiveness, and may not lead to better outcomes.
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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25 people
The number who actually took part.
- Started
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Jul 2013
- Finished
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Nov 2021
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 or cytologically confirmed invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal * Life expectancy of at least 3 months Exclusion Criteria: * Prior abdominopelvic radiotherapy * Prior systemic therapy for anal cancer * Pregnant or breastfeeding * Receiving other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to mitomycin-C or 5-fluorouracil * Prior surgery for cancer of the anus that removed all macroscopic anal cancer * Uncontrolled intercurrent illness * AIDS based on current CDC definition * Other immunocompromised status * Individuals with a history of a different malignancy are ineligible except for the following circumstances: disease-free for at least 5 years or at low risk for recurrence or cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
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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.
Contacts and locations
Locations
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Roberts Proton Therapy Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States