Clinical trial NCT01659203: Proton or Photon RT for Retroperitoneal Sarcomas
Official title: Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) With Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Retroperitoneal Sarcoma
Keywords: extraskeletal chondrosarcoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Roswell Park Cancer Institute
name: National Cancer Institute (NCI)
name: Duke University
name: Rush University Medical Center
name: University of Utah
name: Washington University School of Medicine
name: Mayo Clinic
First posted: 2012-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational intervention. Phase I studies also try to define the appropriate dose of the investigational therapy to use for further studies. "Investigational" means that the intervention is still being studied and that research doctors are trying to find out more about it.

Retroperitoneal sarcomas are soft tissue tumors located at the far back of the abdomen. Typically, patients with retroperitoneal sarcomas either have surgery for the removal of their tumors alone, or have their tumors removed, followed by standard radiation therapy, or have pre-operative radiation followed by surgery. When conventional radiation therapy is delivered after surgery, it can damage normal tissue. In this study, you will undergo proton beam radiation therapy or IMRT before undergoing surgery for the removal of your tumor.

Proton radiation and IMRT are FDA approved radiation delivery systems. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Since proton radiation is more targeted, it may help to reduce unwanted side effects from radiation.

In this study, a standard dose of radiation will be given to the majority of the tumor, while a simultaneously integrated boost of additional radiation will be given to certain areas of the tumor identified as higher risk. This means that a higher radiation dose will be given to the higher risk areas of the tumor.

The purpose of this study is to determine the highest dose of radiation therapy with protons or IMRT that can be delivered safely in patients with retroperitoneal sarcomas and the effectiveness of proton beam radiation therapy as an intervention for patients with retroperitoneal sarcomas.

Detailed description: 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 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 the 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 radiation 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.

Eligibility criteria: 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

Primary outcomes:
measure: Phase I: Determine MTD
timeFrame: 2 years
measure: Phase II: Determine Local Control Rate
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Pathologic Response
timeFrame: 2 years
measure: Tumor Response
timeFrame: 2 years
measure: Progression-Free Survival Times
timeFrame: 2 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Creve Coeur
country: United States
facility: Washington University School of Medicine Siteman Cancer Center West County
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine Siteman Cancer Center South County
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Massachusetts General Hospital
name: Thomas F. DeLaney, M.D.
role: PRINCIPAL_INVESTIGATOR
References: