CompletedPhase 2

Image-Guided Radiation Therapy in Treating Patients With Primary Soft Tissue Sarcoma of the Shoulder, Arm, Hip, or Leg

United States, Canada98 participantsStarted 2008-03

Plain-language 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.

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 primary soft tissue sarcoma of the upper extremity (including shoulder) or lower extremity (including hip) * Incisional or core biopsy required within the past 8 weeks * No histopathological diagnosis of any of the following: * Rhabdomyosarcoma * Extraosseous primitive neuroectodermal tumor (PNET) * Soft tissue Ewing sarcoma * Osteosarcoma * Kaposi sarcoma * Angiosarcoma * Aggressive fibromatosis (desmoid tumor) * Dermatofibrosarcoma protuberans * Chondrosarcoma * Extraskeletal myxoid chondrosarcoma allowed * Tumor must be surgically resectable, as determined by a surgeon within the past 8 weeks * Limb-preservation surgery alone would not provide adequate local control, as determined by the surgeon * No sarcoma of the hand, foot, head, neck, or intra-abdominal or retroperitoneal region or body wall * No sarcoma ≥ 32 cm in any direction * No lymph node or distant metastases, according to the following within the past 8 weeks: * History/physical examination, including a detailed description of the location, size, and stage of the sarcoma * MRI with contrast of the primary tumor * The maximum dimension of the primary tumor is measured in MRI images * CT scan of the chest * Multiple pulmonary nodules \< 8 mm without a histological diagnosis detected incidentally on a non-screening CT scan may be allowed * CT scan with contrast of the abdomen and pelvis in patients with intermedia…

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.

What they're measuring

Rate of 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

Timeframe: 2 years after start of treatment (+/- 3 months)

Trial details

NCT IDNCT00589121

SponsorRadiation Therapy Oncology Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2016-08-25

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