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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00075582 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. It is not yet known which treatment regimen is more effective in treating low-risk rhabdomyosarcoma.
PURPOSE: This phase III trial is studying how well combination chemotherapy and radiation therapy work in treating patients with newly diagnosed low-risk rhabdomyosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: dactinomycin Drug: cyclophosphamide Drug: vincristine sulfate Procedure: conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Vincristine, Dactinomycin, And Lower Doses Of Cyclophosphamide With or Without Radiation Therapy For Patients With Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma |
| Estimated Enrollment: | 360 |
| Study Start Date: | September 2004 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Regimen I (subset 1 patients): Experimental
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiotherapy); and radiotherapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiotherapy; some start it at week 24.
|
Biological: dactinomycin
Given IV
Drug: cyclophosphamide
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Some patients may undergo second-look surgery
Radiation: radiation therapy
Some patients undergo radiotherapy
|
|
Regimen II (subset 2 patients): Experimental
Patients receive VAC chemotherapy and radiotherapy as in regimen I and VA chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiotherapy). Some patients do not receive radiotherapy; some start it at week 24.
|
Biological: dactinomycin
Given IV
Drug: cyclophosphamide
Given IV
Drug: vincristine sulfate
Given IV
Procedure: conventional surgery
Some patients may undergo second-look surgery
Radiation: radiation therapy
Some patients undergo radiotherapy
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2 treatment regimens according to disease stage and clinical group.
In both regimens, treatment continues in the absence of disease progression or unacceptable toxicity.
NOTE: *For both regimens, dactinomycin is omitted during radiotherapy.
NOTE: **Patients with clinical group I disease or completely resected node-negative clinical group III uterine/cervix primary disease do not receive radiotherapy. Patients with node-negative vaginal primary disease receive radiotherapy beginning on week 24, if necessary.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 360 patients (260 for regimen I [subset 1] and 100 for regimen II [subset 2]) will be accrued for this study within 6 years.
Eligibility| Ages Eligible for Study: | up to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed embryonal rhabdomyosarcoma (RMS), botryoid or spindle cell variants of embryonal RMS, or embryonal ectomesenchymoma, meeting criteria for 1 of the following subsets:
Subset 1, defined by meeting 1 of the following criteria:
Subset 2, defined by meeting 1 of the following criteria:
None of the following diagnoses:
PATIENT CHARACTERISTICS:
Age
Under 50
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine* based on age/gender as follows:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Show 188 Study Locations| Study Chair: | David O. Walterhouse, MD | Children's Memorial Hospital |
| Investigator: | Alberto S. Pappo, MD | Texas Children's Cancer Center |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000347078, COG-ARST0331 |
| Study First Received: | January 9, 2004 |
| Last Updated: | June 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00075582 History of Changes |
| Health Authority: | Unspecified |
|
previously untreated childhood rhabdomyosarcoma embryonal childhood rhabdomyosarcoma embryonal-botryoid childhood rhabdomyosarcoma adult rhabdomyosarcoma |
stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma stage I adult soft tissue sarcoma |
|
Immunologic Factors Vincristine Rhabdomyosarcoma, Childhood Antimitotic Agents Cyclophosphamide Immunosuppressive Agents Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Malignant Mesenchymal Tumor |
Soft Tissue Sarcomas Dactinomycin Tubulin Modulators Sarcoma Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents Rhabdomyosarcoma |
|
Neoplasms, Muscle Tissue Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Dactinomycin Therapeutic Uses Alkylating Agents Nucleic Acid Synthesis Inhibitors Rhabdomyosarcoma |
Neoplasms by Histologic Type Myosarcoma Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms Tubulin Modulators Myeloablative Agonists Sarcoma Antineoplastic Agents, Alkylating Antirheumatic Agents |