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Phase III Study of Dactinomycin and Vincristine With or Without Cyclophosphamide and/or Radiotherapy in Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma of Embryonal or Botryoid Subtype
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Alternate Title
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Completed | Under 50 | COG-D9602
CCG-D9602, POG-D9602, IRS-D9602, D9602, NCT00002995 |
Objectives - Determine the failure-free survival (FFS) rate in patients with newly diagnosed low-risk rhabdomyosarcoma of embryonal or botryoid subtype meeting criteria for group I after treatment with dactinomycin and vincristine with or without radiotherapy.
- Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin, vincristine, and cyclophosphamide with or without radiotherapy.
- Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements (embryonal histiotype) who receive one of the above treatments.
- Determine new molecular markers specific to embryonal and botryoid tumor histologies which are of diagnostic and prognostic significance in patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed embryonal (EMB) rhabdomyosarcoma (RMS) or
botryoid or
spindle cell variants of EMB RMS or embryonal ectomesenchymoma meeting 1 of the following criteria:
- Stage 1, no clinical group IV: Tumor in favorable
site (orbit, head and neck
[excluding parameningeal], genitourinary [not
bladder/prostate], or biliary
tract) and no metastatic disease
- Stage 2 or 3, clinical group I or II: Tumor in
unfavorable site
(bladder/prostate, extremity, cranial parameningeal,
trunk, retroperitoneum,
pelvis, perineal/perianal, intrathoracic,
gastrointestinal, or
liver), no gross residual disease after initial
surgery, and no
metastatic disease
- Must have ipsilateral lymph node dissection if age 10 or over with
primary paratesticular cancer OR under age 10 with clinically
positive
regional lymph nodes
- Low risk of recurrence
- Previously untreated disease
- No alveolar RMS or undifferentiated sarcoma
- No intermediate-risk disease
- No metastatic disease at diagnosis
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Patient Characteristics:
Age: Performance status: Hematopoietic: Hepatic: - Bilirubin elevation secondary to biliary or hepatic primaries allowed
Renal: - Creatinine elevation secondary to tumor obstruction allowed
Other: - No uncontrolled infection
- Not pregnant or nursing
- Fertile patients must use effective contraception
Expected Enrollment 254A total of 254 patients for group I will be accrued for this study within 6
years. Approximately 12 patients per year will be accrued for group II. Outline Patients are assigned to 1 of 2 groups, depending on histology and site of
disease. - Group I (favorable tumor site, negative lymph nodes, stage 1, clinical
group I, IIA, or III (orbit only), node negative [N0] OR unfavorable tumor site, negative or unknown lymph nodes, stage
2, clinical group I): Patients receive vincristine IV over 1 minute weekly for 8 weeks and
dactinomycin IV over 1 minute once every 3 weeks for 4 doses. Treatment repeats every
12 weeks for 4 courses. Radiotherapy is administered to patients with
clinical group II or III disease on weeks 3-8.
- Group II (favorable tumor site, positive lymph nodes, stage 1, clinical
group III (orbit only), node positive [N1] OR favorable tumor site except orbit, any lymph nodes, stage 1,
clinical group III OR unfavorable tumor site, stage 2, clinical group II OR unfavorable tumor site, stage 3, clinical group I or II): Patients receive vincristine and dactinomycin as in group I. Patients also receive cyclophosphamide IV over 30-60 minutes and filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously once daily beginning 24 hours after completion of chemotherapy and continuing for 10 days or until blood counts recover. Radiotherapy is administered on weeks 3-8,
12-17, or 28-33, if clinically indicated as in group I.
Patients are followed every 3-4 months for 3 years (4 years after
diagnosis), every 6 months for 1 year, and then annually thereafter.
Trial Contact Information
Trial Lead Organizations Children's Oncology Group | | | | R. Beverly Raney, MD, Protocol chair(Contact information may not be current) | | | Ph: 512-420-8180; 800-392-1611 |
| |
| Registry Information | | | Official Title | | Actinomycin D and Vincristine with or without Radiation Therapy, for Newly Diagnosed Patients with Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma: IRS-V Protocol | | | Trial Start Date | | 1997-08-01 | | | Registered in ClinicalTrials.gov | | NCT00002995 | | | Date Submitted to PDQ | | 1997-04-16 | | | Information Last Verified | | 2004-02-11 | | | NCI Grant/Contract Number | | CA24507 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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