RATIONALE: Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin, radiation therapy, and/or surgery works in treating young patients with localized soft tissue sarcoma.
Who can participate
Age range
20 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 synovial sarcoma or adult-type soft-tissue sarcoma
* Adult-type soft tissue sarcoma includes any of the following:
* Fibrosarcoma (adult-type)
* No infantile fibrosarcoma
* Malignant peripheral nerve sheath tumor
* Malignant schwannoma
* Neurofibrosarcoma
* Epithelioid sarcoma
* Leiomyosarcoma
* Clear cell sarcoma
* Liposarcoma
* Alveolar soft-part sarcoma
* Malignant fibrous histiocytoma
* Hemangiopericytoma
* Angiosarcoma
* Dermatofibrosarcoma protuberans
* Mesenchymal chondrosarcoma
* No borderline tumors (e.g., hemangioendothelioma)
* No small round cell tumors (e.g., extraosseous Ewing's sarcoma/primitive neuroectodermal tumor or desmoplastic small round cell tumor)
* Post-irradiation soft-part sarcomas allowed
* Diagnostic surgery performed within the past 8 weeks (for patients who require adjuvant chemotherapy)
* No evidence of metastatic disease
* Involved locoregional lymph nodes are allowed
PATIENT CHARACTERISTICS:
* No prior malignancy
* No pre-existing illness precluding study treatment\*
* Normal renal function (nephrotoxicity grade 0-1)\*
* No history of cardiac disease\*
* Normal shortening fraction (\> 28%)\*
* Ejection fraction \> 47%\* NOTE: \* For patients who require adjuvant chemotherapy
PRIOR CONCURRENT THERAPY:
* No prior cancer treatment except primary surgery
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
1
Event-free survival
2
Local relapse-free survival
3
Metastases-free survival
4
Overall survival
5
Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)
Trial details
NCT IDNCT00334854
SponsorEuropean Paediatric Soft Tissue Sarcoma Study Group