Clinical trial · Interventional
Concurrent Chemoradiation + 5-FU + Mitomycin-C in Anal Carcinoma
A Pilot Feasibility Study of Definitive Concurrent Chemoradiation With Pencil Beam Scanning Proton Beam in Combination With 5-Fluorouracil and Mitomycin-C for Carcinoma of the Anal Canal
- 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 research study is a Pilot Study. Pilot studies are conducted to see if it is practical to do this type of research ona larger scale in the future. The pilot part of the study is to assess the possibility of using pencil beam proton radiation to treat your type of cancer. Proton radiation is used for many other types of malignancies, but its use for the treatment of anal cancer has been limited. The treatment is still being studied as research doctors are trying to find out more about its use in the treatment of anal cancer. Proton beam radiation therapy is an FDA approved radiation delivery system. You are being asked to participate in this study because you have cancer in the anal canal. Conventional radiation therapy with photons in combination with 5-FU and mitomycin-C is used as standard treatment for many patients with anal cancer. In this research study we are looking at another type of radiation called proton radiation, which is known to spare surrounding tissue and organs from radiation. Proton radiation delivers radiation to the area requiring radiation but delivers no dose beyond the region requiring treatment. There are several techniques that can be used to deliver proton radiation therapy. One of the newer techniques, called pencil beam scanning, allows for more accurate delivery of radiation to your tumor and further reduces the amount of normal tissue exposed to radiation. Most proton patients are treated with a number of beams that study doctors conform to the shape of your tumor. Pencil beam scanning delivers radiation with a single, narrow proton beam that is swept over the area of your tumor. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy, and also minimizes treatment time. In this research study, we are evaluating the effectiveness of using pencil beam proton radiation delivered to reduce side effects associated with radiation treatment.
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 |
|---|---|---|---|
| Carcinoma of the Anal Canal | Anal Canal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-fluorouracil | Drug | Fluorouracil | ALIAS |
| Mitomycin-C | Drug | Mitomycin | ALIAS |
| Pencil Beam scanning Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pencil Beam Scanning Radiation
- description
- Pencil Beam Radiation daily, Monday-Friday, for 5-6 weeks Mitomycin-C via IV on Days 1 and 29 5-Fluorouracil via infusion pump over 4 days, starting Day 1 and 29 of chemotherapy
- interventionNames
- Radiation: Pencil Beam scanning Radiation
- Drug: 5-fluorouracil
- Drug: Mitomycin-C
Primary outcomes (1)
- measure
- Feasibility of administration of pencil beam scanning proton beam radiation with chemotherapy for anal cancer
- timeFrame
- 2 years
- description
- The primary objective of this study is to determine feasibility of administration of pencil beam scanning proton beam radiotherapy in combination with concurrent 5-fluorouracil (5-FU) and mitomycin-C for carcinoma of the anal canal. Proton radiotherapy will be considered feasible if grade 3+ skin toxicity seen on this protocol is less than 48% (reported grade 3+ dermatologic toxicity from RTOG 98-11)
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWo JY, Plastaras JP, Metz JM, Jiang W, Yeap BY, Drapek LC, Adams J, Baglini C, Ryan DP, Murphy JE, Parikh AR, Allen JN, Clark JW, Blaszkowsky LS, DeLaney TF, Ben-Josef E, Hong TS. Pencil Beam Scanning Proton Beam Chemoradiation Therapy With 5-Fluorouracil and Mitomycin-C for Definitive Treatment of Carcinoma of the Anal Canal: A Multi-institutional Pilot Feasibility Study. Int J Radiat Oncol Biol Phys. 2019 Sep 1;105(1):90-95. doi: 10.1016/j.ijrobp.2019.04.040. Epub 2019 May 22. PMID 31128146