NCT01659203 Proton or Photon RT for Retroperitoneal Sarcomas
| NCT ID | NCT01659203 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Retroperitoneal Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2012-12 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2012-12 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Thomas F. DeLaney, M.D.
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT01659203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Retroperitoneal Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01659203 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01659203 currently recruiting?
Yes, NCT01659203 is actively recruiting participants. Contact the research team at tdelaney@partners.org for enrollment information.
Where is the NCT01659203 trial being conducted?
This trial is being conducted at Chicago, United States, Boston, United States, Boston, United States, Rochester, United States and 6 additional locations.
Who is sponsoring the NCT01659203 clinical trial?
NCT01659203 is sponsored by Massachusetts General Hospital. The principal investigator is Thomas F. DeLaney, M.D. at Massachusetts General Hospital. The trial plans to enroll 80 participants.