Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

Basic Trial Information

Objectives

1. 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.
2. Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin, vincristine, and cyclophosphamide with or without radiotherapy.
3. Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements (embryonal histiotype) who receive one of the above treatments.
4. 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

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Patient Characteristics:

Age:

• Under 50

Performance status:

• Not specified

Hematopoietic:

• Not specified

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

A 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.

Beverly Raney R, Walterhouse DO, Meza JL, et al.: Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol 29 (10): 1312-8, 2011.[PUBMED Abstract]

Breneman J, Meza J, Donaldson SS, et al.: Local Control with Reduced-Dose Radiotherapy for Low-Risk Rhabdomyosarcoma: A Report from the Children's Oncology Group D9602 Study. Int J Radiat Oncol Biol Phys : , 2011.[PUBMED Abstract]

Malempati S, Rodeberg DA, Donaldson SS, et al.: Rhabdomyosarcoma in infants younger than 1 year: a report from the Children's Oncology Group. Cancer 117 (15): 3493-501, 2011.[PUBMED Abstract]

Walterhouse DO, Meza JL, Breneman JC, et al.: Local control and outcome in children with localized vaginal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma committee of the Children's Oncology Group. Pediatr Blood Cancer 57 (1): 76-83, 2011.[PUBMED Abstract]

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
Trial Completion Date		2006-09-25
Registered in ClinicalTrials.gov		NCT00002995
Date Submitted to PDQ		1997-04-16
Information Last Verified		2010-11-18
NCI Grant/Contract Number		CA24507

Back to Top