Concurrent Chemoradiation + 5-FU + Mitomycin-C in Anal Carcinoma

NCT01858025 | Completed Early Phase 1 DMC

• 1 other identifier: 13-075
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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

Carcinoma of the Anal Canal

Outcome Measures

Primary Outcomes (1)

• Feasibility of administration of pencil beam scanning proton beam radiation with chemotherapy for anal cancer

  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)

  2 years

Secondary Outcomes (11)

• Assessment of Adverse Events

  2 years

• Quality of Life Outcomes

  2 years

• Clinical Complete Response

  12 weeks

• Radiotherapy treatment time

  2 years

• Local-regional failure

  2 years

Study Arms (1)

Pencil Beam Scanning Radiation

EXPERIMENTAL

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

Radiation: Pencil Beam scanning Radiation; Drug: 5-fluorouracil; Drug: Mitomycin-C

Interventions

Pencil Beam scanning Radiation RADIATION

Pencil Beam Scanning Radiation

5-fluorouracil DRUG

Also known as: 5-FU

Pencil Beam Scanning Radiation

Mitomycin-C DRUG

Pencil Beam Scanning Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed invasive primary squamous, basaloid or cloacogenic carcinoma of the anal canal
• Life expectancy of at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Roberts Proton Therapy Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Wo 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 DERIVED

MeSH Terms

Interventions

Fluorouracil; Mitomycin

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jennifer Y. Wo, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2013
• First Posted: May 20, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2021
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (2)