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NCT01659203 · ClinicalTrials.gov registry record · Phase 1
Proton or Photon RT for Retroperitoneal Sarcomas
A Phase 1 study of Retroperitoneal Sarcoma, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 10
- Study locations
NCT01659203 is a Phase 1 study of Retroperitoneal Sarcoma that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 80 participants, below the 403-participant average among 6 other Retroperitoneal Sarcoma trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 8 states.
The verdict
NCT01659203, a Phase 1 study of Retroperitoneal Sarcoma, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 10
- Study locations
Study 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.
Conditions Studied
Interventions
- RADIATION IG-IMPT
- RADIATION IG IMRT
Study Locations (10)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Missouri
- Washington University School of Medicine Siteman Cancer Center West County - Creve Coeur
- Washington University School of Medicine Siteman Cancer Center South County - St Louis
Illinois
- Rush University Medical Center - Chicago
Minnesota
- Mayo Clinic - Rochester
New York
- Roswell Park Cancer Institute - Buffalo
North Carolina
- Duke University - Durham
Texas
- MD Anderson Cancer Center - Houston
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2012-12 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01659203
The ClinicalTrials.gov registry entry for NCT01659203 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 403-participant average among 6 other Retroperitoneal Sarcoma trials with a reported enrollment target (80% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Retroperitoneal Sarcoma appearing as the primary indexed condition, and to 2 interventions - of which IG-IMPT is the first listed.
NCT01659203 reports 10 study locations spanning 8 distinct geographic areas - top geographies include Massachusetts, Missouri, Illinois.
Frequently Asked Questions
What is clinical trial NCT01659203 about?
NCT01659203 is a clinical study titled "Proton or Photon RT for Retroperitoneal Sarcomas". 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...
What is the current status of trial NCT01659203?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2012-12. Estimated completion is 2027-12-31.
What conditions does trial NCT01659203 study?
This clinical trial studies the following conditions: Retroperitoneal Sarcoma.
What interventions are being tested in trial NCT01659203?
The interventions under investigation include: IG-IMPT (RADIATION), IG IMRT (RADIATION).
Who is sponsoring clinical trial NCT01659203?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01659203 being conducted?
This trial has 10 study locations across Illinois, Massachusetts, Minnesota, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.