Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy 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. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma.

PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.

Condition	Intervention	Phase
Sarcoma	Biological: dactinomycin Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Drug: vincristine sulfate Radiation: radiation therapy	Phase 3


Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Soft Tissue Sarcoma

Genetic and Rare Diseases Information Center resources: Soft Tissue Sarcoma Embryonal Sarcoma Malignant Mesenchymoma

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:

Failure-free survival


Enrollment:	483
Study Start Date:	August 1997
Study Completion Date:	January 2011
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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.

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.

Eligibility


Ages Eligible for Study:	up to 49 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002995

Show 233 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	R. Beverly Raney, MD	M.D. Anderson Cancer Center

More Information

Publications:

Breneman J, Meza J, Donaldson SS, Raney RB, Wolden S, Michalski J, Laurie F, Rodeberg DA, Meyer W, Walterhouse D, Hawkins DS. 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. 2012 Jun 1;83(2):720-6. doi: 10.1016/j.ijrobp.2011.06.2011. Epub 2011 Nov 19.

Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. 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. 2011 Apr 1;29(10):1312-8. doi: 10.1200/JCO.2010.30.4469. Epub 2011 Feb 28.

Malempati S, Rodeberg DA, Donaldson SS, Lyden ER, Anderson JR, Hawkins DS, Arndt CA. Rhabdomyosarcoma in infants younger than 1 year: a report from the Children's Oncology Group. Cancer. 2011 Aug 1;117(15):3493-501. doi: 10.1002/cncr.25887. Epub 2011 Jan 24.

Walterhouse DO, Meza JL, Breneman JC, Donaldson SS, Hayes-Jordan A, Pappo AS, Arndt C, Raney RB, Meyer WH, Hawkins DS. 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. 2011 Jul 15;57(1):76-83. doi: 10.1002/pbc.22928. Epub 2011 Feb 4.


Responsible Party:	Children's Oncology Group
ClinicalTrials.gov Identifier:	NCT00002995 History of Changes
Other Study ID Numbers:	D9602 COG-D9602 ( Other Identifier: Children's Oncology Group ) CCG-D9602 ( Other Identifier: Children's Cancer Group ) POG-D9602 ( Other Identifier: Pediatric Oncology Group ) IRS-D9602 ( Other Identifier: Intergroup Rhabdosarcoma ) CDR0000065542 ( Other Identifier: Clinical Trials.gov )
Study First Received:	November 1, 1999
Last Updated:	February 12, 2014

Keywords provided by Children's Oncology Group:


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

Additional relevant MeSH terms:


Sarcoma Rhabdomyosarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Myosarcoma Neoplasms, Muscle Tissue Cyclophosphamide Vincristine Dactinomycin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating	Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Protein Synthesis Inhibitors Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 17, 2017