A Phase 2 interventional study of dactinomycin and cyclophosphamide in Sarcoma, sponsored by Japan Rhabdomyosarcoma Study Group. Status unknown at 51 sites in Japan. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2013-08-12.
Sponsored by Japan Rhabdomyosarcoma Study Group · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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 more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.
OBJECTIVES:
OUTLINE: Patients receive vincristine IV, dactinomycin IV, and cyclophosphamide IV. Patients may also undergo radiotherapy. Treatment repeats every 3 weeks for up to 8 courses (total of 24 weeks) in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
238 studies on the registry are indexed under Rhabdomyosarcoma; 47 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 191 interventional studies indexed under Rhabdomyosarcoma.
Browse Rhabdomyosarcoma studies →Japan Rhabdomyosarcoma Study Group is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of embryonal rhabdomyosarcoma
The following variants are eligible:
Meets 1 of the following stage criteria:
Stage I, clinical group I or II (N0), defined by all of the following criteria:
Stage I, clinical group III (N0), defined by all of the following criteria:
Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age as follows:
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Radiotherapy
Other
Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
Overall survival as measured by Kaplan-Meier method 3 years after study entry
Progression-free survival as measured by Kaplan-Meier method during events
Complete response rate (orbit, group III only) at completion of study treatment
Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry
This study is status unknown, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Japan Rhabdomyosarcoma Study Group