Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Japan Rhabdomyosarcoma Study Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00245141 |
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.
Condition | Intervention | Phase |
---|---|---|
Sarcoma |
Drug: cyclophosphamide Drug: dactinomycin Drug: vincristine sulfate Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma |
Estimated Enrollment: | 32 |
Study Start Date: | May 2004 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study Chair: | Hajime Hosoi | Kyoto Prefectural University of Medicine |
Investigator: | Masa-aki Kumagai, MD | National Center for Child Health and Development |
Study ID Numbers: | CDR0000453316, JRSG-UHA-PED03-01 |
Study First Received: | October 25, 2005 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00245141 |
Health Authority: | Unspecified |
embryonal childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma |
Rhabdomyosarcoma, Embryonal Neoplasms, Connective and Soft Tissue Dactinomycin Malignant mesenchymal tumor Sarcoma |
Vincristine Cyclophosphamide Rhabdomyosarcoma, embryonal Soft tissue sarcomas Rhabdomyosarcoma |
Neoplasms, Muscle Tissue Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Anti-Bacterial Agents Therapeutic Uses Alkylating Agents Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Myosarcoma |
Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |