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 States109 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 range49 Years
SexALL
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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…
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