High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnose… (NCT00354744) | Clinical Trial Compass
CompletedPhase 3
High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
United States, Australia, Canada109 participantsStarted 2006-07
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.
Who can participate
Age range
49 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 high-risk rhabdomyosarcoma or ectomesenchymoma
* Prior enrollment on COG-D9902 to confirm local histological diagnosis required
* Tissue must be submitted for pathologic review within 2 days of patient registration on COG-D9902
* Newly diagnosed disease
* Metastatic disease (stage IV, clinical group IV)
* Has undergone initial surgical procedure (including biopsy) that provided the definitive diagnosis within the past 42 days
* Parameningeal and paraspinal tumors allowed
* Patients with parameningeal (without intracranial extension \[ICE\]) and paraspinal tumors should begin study chemotherapy at week 1 and radiotherapy at week 20
* Patients with evidence of ICE, as defined by contrast MRI showing that primary tumor touches, displaces, invades, distorts, or otherwise causes a signal abnormality of the dura in contiguity to the primary site in brain or spinal cord, are eligible
* ICE is presumed to exist if the cerebrospinal fluid cytopathology is positive for tumor at diagnosis
* Patients requiring emergency radiotherapy are eligible
* Patients requiring emergency radiotherapy (for intracranial extension or spinal cord impingement) should begin study chemotherapy at week 1 (irinotecan hydrochloride and vincristine) concurrently with radiation therapy
PATIENT CHARACTERISTICS:
* ECOG or Zubrod performance status (PS) 0-2 (Lansky PS 50-100% for patients \< 10 years of age and Karnofsky PS 50-100% for pat…
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
Number of Patients With Complete or Partial Response Assessed by RECIST Criteria
Timeframe: Protocol week 6 evaluation
2
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy