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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

Phase 0
18 Years
Not Enrolling
Carcinoma of the Anal Canal

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Trial Information

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

If you agree to participate in this study, you will be asked to undergo some screening tests
or procedures to confirm that you are eligible. Many of these tests and procedures are
likely to be part of regular cancer care and may be done even if it turns out that you do
not take part in the research study. If you have had some of these tests or procedures
recently, they may or may not have to be repeated. The screening will include the following:
a medical history, physical examination, biopsy of your tumor, anal and groin exam, archival
tumor tissue, CT or PET-CT, MRI, blood tests and a serum pregnancy test. If these tests show
that you are eligible to participate in the research study, you will begin the study
treatment. If you do not meet the eligibility criteria, you will not be able to participate
in this research study.

Proton Radiation will be delivered daily for 5-6 weeks, depending on the dose prescribed by
your physician. Treatment is delivered (Monday-Friday) for 5 days (no weekends or holidays).
Each treatment will require that you lie on a table for 25-30 minutes.

You will receive radiation therapy as an outpatient at the Massachusetts General Hospital.

You will start receiving chemotherapy within 3 days of starting radiation treatment. The day
you start chemotherapy will be considered Day 1.

You will receive Mitomycin-C on Days 1 and 29 of chemotherapy. Mitomycin-C will be delivered
via IV infusion over a period of 10-30 minutes.

You will receive 5-fluorouracil on Day 1 and 29 of chemotherapy. You will be fitted with an
ambulatory infusion pump that will administer 5-FU via IV infusion continuously over a
period of 96 hours. The infusion pump will be about the size of a paperback book that can
fit into a front-pack or "fanny-pack" around your waist. This pump will be connected to your
body. The nurses in the infusion room will start the pump and disconnect it after 4 days.

At your 6 and 12 week follow up visits, a physical examination and the tests and procedures
you receive will tell your study doctor whether your disease has gotten better, worse or
stayed the same.

If your cancer has gotten better, you will continue to be monitored at your follow up

If your cancer is suspected to have gotten worse, you will need to have a biopsy to confirm.
If the biopsy is negative, you will need to come back for re-evaluation at 16 weeks (about 4
months) after completing radiation therapy.

If the biopsy confirms that your cancer has gotten worse, your doctor will recommend that
you have surgery for the removal of your tumor.

If your cancer has stayed the same, your doctor will recommend that you have additional
procedures done to develop a plan for treatment.

After you complete radiation therapy, you will be followed for up to 5 years.

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 and at low risk for
recurrence or cervical cancer in situ, and basal cell or squamous cell carcinoma of
the skin

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome 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)

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jennifer Wo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

July 2013

Completion Date:

Related Keywords:

  • Carcinoma of the Anal Canal
  • Carcinoma



Massachusetts General HospitalBoston, Massachusetts  02114-2617