Carcinoma of the Anal Canal Clinical Trial
Official title:
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
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.
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 5 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 visits.
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.
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