Clinical trial · Interventional
Proton Therapy in Reducing Toxicity in Anal Cancer
A Prospective Pilot Study to Evaluate the Feasibility of Intensity Modulated Proton Therapy in Reducing Toxicity in Anal Cancer
NCT03018418CI-TRIAL-00080860unknownPhase 2Results postedClinicalTrials.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)
The purpose of this research study is to determine whether the amount of radiation given to the normal areas around the anal cancer can be reduced by using Proton Therapy while reducing the side effects that are seen with standard therapy.
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 |
|---|---|---|---|
| Anus Neoplasms | Anal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Therapy and Chemotherapy
- description
- Standard chemoradiation using 5-FU, Mitomycin, with pencil beam proton radiotherapy
- interventionNames
- Radiation: Proton therapy
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Rates of Acute Toxicity
- timeFrame
- 3 months
- description
- Grade 3 or greater hematologic, gastrointestinal, genitourinary, and dermatologic toxicity
Secondary outcomes (6)
- measure
- Rates of Late Toxicity
- timeFrame
- every 6 months up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Karnofsky Performance Status \>70% * Histologically documented squamous or basaloid carcinoma of the anal canal * Stage T2-4 disease with any N category Exclusion Criteria: • Patients with a life expectancy of \< 3 months.
References
Publications (0)
Data not yet available
No reference posted for this study.