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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/NCT00003955




Registration number
NCT00003955
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 Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma
Scientific title
A Phase II "Up-Front Window Study" of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study
Secondary ID [1] 0 0
COG-D9802
Secondary ID [2] 0 0
D9802
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 - pegfilgrastim
Other interventions - sargramostim
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - irinotecan hydrochloride
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy

Other interventions: dactinomycin


Other interventions: filgrastim


Other interventions: pegfilgrastim


Other interventions: sargramostim


Treatment: Drugs: cyclophosphamide


Treatment: Drugs: irinotecan hydrochloride


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
Event Free Survival
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma,
undifferentiated sarcoma, or ectomesenchymoma

- No metastatic embryonal tumors in patients under 10 years of age, regardless of
primary site

- Metastatic tumors of parameningeal sites eligible

- Bidimensionally measurable disease

- No positive cerebrospinal fluid cytology or multiple intracranial metastases

- Patients presenting with the following are only eligible for continuation therapy and
may not receive irinotecan/vincristine upfront window therapy:

- Evidence of base of skull erosion or skull metastatic disease that displaces or
indents the dura, compresses the brain parenchyma, or causes evidence of cranial
nerve palsy

- Tumor that touches or displaces the spinal cord

- Evidence of intracranial primary tumor extension

- Tumors that could cause potentially life-threatening complications (e.g., renal,
airway) with progression due to location and/or growth rate

- Requires emergency radiotherapy

- Lab values are consistent with disseminated intravascular coagulation

PATIENT CHARACTERISTICS:

Age:

- Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma
patients)

- 10 to 49 (embryonal histology patients)

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

- Absolute neutrophil count greater than 1,000/mm^3*

- Platelet count greater than 150,000/mm^3* NOTE: *Unless there is tumor involvement of
bone marrow

Hepatic:

- Bilirubin less than 1.5 mg/dL

- PT, PTT, and fibrinogen less than 1.5 times upper limit of normal

Renal:

- Creatinine less than 1.2 mg/dL

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior steroids allowed

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy

Surgery:

- No more than 42 days since prior initial surgical procedure, including biopsy for
diagnosis
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 2
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
1/09/1999
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2009
Sample size
Target
Accrual to date
Final
77
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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Arizona
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Idaho
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Illinois
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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 use 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.
Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with
radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00003955
Trial related presentations / publications
Soft Tissue Sarcoma Committee of the Children's Oncology Group; Lager JJ, Lyden ER, Anderson JR, Pappo AS, Meyer WH, Breitfeld PP. Pooled analysis of phase II window studies in children with contemporary high-risk metastatic rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2006 Jul 20;24(21):3415-22. doi: 10.1200/JCO.2005.01.9497.
Public notes

Contacts
Principal investigator
Name 0 0
Alberto S. Pappo, MD
Address 0 0
Texas Children's 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/NCT00003955