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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00002995




Registration number
NCT00002995
Ethics application status
Date submitted
1/11/1999
Date registered
27/01/2003
Date last updated
14/02/2014

Titles & IDs
Public title
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
Scientific title
Actinomycin D and Vincristine With or Without Radiation Therapy, for Newly Diagnosed Patients With Low-Risk Rhabdomyosarcoma or Undifferentiated Sarcoma: IRS-V Protocol
Secondary ID [1] 0 0
COG-D9602
Secondary ID [2] 0 0
D9602
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Children's - Other

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - dactinomycin
Other interventions - filgrastim
Other interventions - sargramostim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy

Other interventions: dactinomycin


Other interventions: filgrastim


Other interventions: sargramostim


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: vincristine sulfate


Treatment: Other: radiation therapy
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failure-free survival
Timepoint [1] 0 0

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
483
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002995
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
R. Beverly Raney, MD
Address 0 0
M.D. Anderson Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002995