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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Retroperitoneal Sarcoma

Thank you

Trial Information

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.


Inclusion Criteria:



- Histologically proven primary soft tissue sarcoma of the retroperitoneum

- Measurable disease

- Life expectancy of greater than 2 years

Exclusion Criteria:

- Prior radiation therapy for retroperitoneal sarcoma

- Pregnant or breastfeeding

- Chemotherapy within 4 weeks prior to entering study

- Receiving other investigational agents

- Other types of sarcomas

- Multifocal disease, lymph node or distant metastases

- History of sensitivity to radiation therapy

- Uncontrolled intercurrent illness

- History of a different invasive malignancy within the past 3 years

- HIV positive on combination anti-retroviral therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase I: Determine MTD

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Thomas F. DeLaney, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

12-100

NCT ID:

NCT01659203

Start Date:

December 2012

Completion Date:

Related Keywords:

  • Retroperitoneal Sarcoma
  • extraskeletal chondrosarcoma
  • Sarcoma

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617