|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 5, 2008 | ||||||||||||||||||||
| Last Updated Date | October 29, 2009 | ||||||||||||||||||||
| Start Date ICMJE | March 2008 | ||||||||||||||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC/RTOG criteria [ Designated as safety issue: Yes ] | ||||||||||||||||||||
| Original Primary Outcome Measures ICMJE |
Effect of reduced radiation volume using image-guided radiotherapy (IGRT) on late radiation morbidity (≥ grade 2 lymphedema, subcutaneous fibrosis, or joint stiffness) at 2 years from the start of radiotherapy as measured by EORTC/RTOG criteria [ Designated as safety issue: Yes ] | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00589121 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg | ||||||||||||||||||||
| Official Title ICMJE | A Phase II Trial of Image Guided Preoperative Radiotherapy for Primary Soft Tissue Sarcomas of the Extremity | ||||||||||||||||||||
| Brief Summary | RATIONALE: Image-guided radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a lower dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying the side effects and how well image-guided radiation therapy works in treating patients with primary soft tissue sarcoma of the shoulder, arm, hip, or leg. |
||||||||||||||||||||
| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. |
||||||||||||||||||||
| Study Phase | Phase II | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Design ICMJE | Treatment | ||||||||||||||||||||
| Condition ICMJE |
|
||||||||||||||||||||
| Intervention ICMJE |
|
||||||||||||||||||||
| Study Arms / Comparison Groups |
|
||||||||||||||||||||
| Publications * | |||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 102 | ||||||||||||||||||||
| Completion Date | |||||||||||||||||||||
| Estimated Primary Completion Date | November 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
|
||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | |||||||||||||||||||||
| Location Countries ICMJE | United States, Canada | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT ID ICMJE | NCT00589121 | ||||||||||||||||||||
| Responsible Party | Walter John Curran, Jr, Radiation Therapy Oncology Group | ||||||||||||||||||||
| Study ID Numbers ICMJE | CDR0000582196, RTOG-0630 | ||||||||||||||||||||
| Study Sponsor ICMJE | Radiation Therapy Oncology Group | ||||||||||||||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||
| Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||
| Verification Date | October 2009 | ||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||