Phase I/II Trial of Pre-Operative Image Guided Modulated Proton Radiation Therapy (IMPT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
While being screened to determine eligibility for this study you may choose to participate
in an additional blood sample for circulating DNA and a genomic DNA sample.
Since we are looking for the highest dose of Proton Beam Radiation Therapy that can be
administered safely without severe or unmanageable side effects in participants that have
retroperitoneal sarcomas, not everyone who participates in this research study will receive
teh same dose of study therapy. The dose you get will depend on the number of participants
who have been enrolled in the study before you and how well they have tolerated their doses.
Your study doctor will tell you which dose you will get.
Radiation planning is standard of care for all patients undergoing radiation therapy. Before
you begin radiation therapy you will have a radiation planning CT scan of the tumor site.
This scan will be in addition to the scans done in order to confirm your eligibility for
this study. Doctors will use teh images from this scan to plan your radiation treatment.
You will receive radiation therapy every day Monday through Friday for about six weeks. You
will receive study therapy as an outpatient. During radiation therapy, you will be seen by
the study doctor once a week. Each visit will take about 15 minutes, and the following
assessments will be completed: medical history, vital signs, body weight and assessments for
any side effects you may be experiencing.
After the final dose of proton therapy you will be assessed for side effects of radiation
following your last dose and before surgery. The following assessments will be completed
before your surgery at this visit: Chest CT, CT/MRI of the abdomen/pelvis and routine blood
tests to check for overall health.
You will be seen for a follow-up visit within one month of discharge following surgery and
again four months after the surgery. At the first follow-up visit, the following assessment
will be completed: medical history, vital signs and body weight, questions about side
effects and routine blood tests to check for overall health. At the four month follow up
visit the following assessment will be completed: medical history, vital signs and body
weight, chest CT and abdominal/pelvic CT.
After your four month follow-up visit, you will be seen twice yearly following radiation for
the first five years and then once a year for the rest of your life.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Determine MTD
To determine the maximum tolerated dose (MTD) of preoperative IG-IMPT with simultaneously integrated boost to the high risk margin of retroperitoneal sarcoma. This is mainly based on evaluation of acute toxicity profile of each participant.
Thomas F. DeLaney, M.D.
Massachusetts General Hospital
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|