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Actinomycin D and Vincristine With or Without Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma: IRS-V Protocol

Phase 3
49 Years
Not Enrolling

Thank you

Trial Information

Actinomycin D and Vincristine With or Without Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma: IRS-V Protocol


- 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

- Determine new molecular markers specific to embryonal and botryoid tumor histologies
which are of diagnostic and prognostic significance in patients treated with these

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.

PROJECTED ACCRUAL: 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.

Inclusion Criteria


- 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



- Under 50

Performance status:

- Not specified


- Not specified


- Bilirubin elevation secondary to biliary or hepatic primaries allowed


- Creatinine elevation secondary to tumor obstruction allowed


- No uncontrolled infection

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

R. Beverly Raney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

August 1997

Completion Date:

Related Keywords:

  • Sarcoma
  • embryonal childhood rhabdomyosarcoma
  • embryonal-botryoid childhood rhabdomyosarcoma
  • previously untreated childhood rhabdomyosarcoma
  • adult rhabdomyosarcoma
  • adult malignant mesenchymoma
  • childhood malignant mesenchymoma
  • nonmetastatic childhood soft tissue sarcoma
  • stage II adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage I adult soft tissue sarcoma
  • Rhabdomyosarcoma
  • Sarcoma



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