Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage… (NCT00740597) | Clinical Trial Compass
TerminatedPhase 2
Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma
Stopped: No patients were enrolled on the study
United States1 participantsStarted 2008-07
Plain-language summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation therapy and to see how well it works in treating patients undergoing surgery for stage IB, stage II, or stage III soft tissue sarcoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care
* Stage IB-III disease
* Primary or locally recurrent disease
* The following chemotherapy-sensitive STS histologies are excluded:
* Primitive neuroectodermal tumor
* Desmoplastic small round cell tumor
* Synovial sarcoma
* Myxoid round cell liposarcoma
* Angiosarcoma
* No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma)
* No retroperitoneal STS
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Able to complete the self-assessment questionnaires (may use translator service)
* Willing and able to undergo pre-treatment core needle biopsies
* Negative pregnancy test
* No known HIV positivity
PRIOR CONCURRENT THERAPY:
* Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease
* At least 1 year since prior adjuvant chemotherapy
* No prior radiotherapy to the site of present STS
* No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.