Diseases and Conditions Researched
Rhabdomyosarcoma
What is the purpose of this trial?
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, cyclophosphamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma.
Participation Guidelines
Age:
Up to 50 Years
Gender: Both
Click here for
detailed participation information for this trial.
|
Sponsors:
|
Children's Oncology Group; National Cancer Institute (NCI) |
| Dates: |
July 19, 2006 |
| Last Updated: |
December 2, 2010 |
| Study HIC#: |
1008007246 |
| Clinicaltrials.gov ID: |
NCT00354835
|
Condition
Rhabdomyosarcoma
Interventions Details
| Biological:
|
dactinomycin |
| Drug:
|
cyclophosphamide |
| Drug:
|
irinotecan hydrochloride |
| Drug:
|
vincristine sulfate |
| Radiation:
|
radiation therapy |
Trial Phase
Phase 3
Trial Purpose
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, cyclophosphamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective when given together with radiation therapy in treating patients with rhabdomyosarcoma.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed rhabdomyosarcoma.
Participation Guidelines
Age:
Up to 50 Years
Gender: Both
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed rhabdomyosarcoma (RMS)
- Must be concurrently enrolled on COG-D9902 to confirm local histologic diagnosis
- Intermediate-risk disease, defined by 1 of the following surgicopathologic and
staging criteria:
- Group III, stage 2 or 3 embryonal, botryoid, or spindle cell RMS
- Group III, stage 2 or 3 ectomesenchymoma
- Group I-III, stage 1-3 alveolar RMS
- Newly diagnosed disease
- Staging ipsilateral retroperitoneal lymph node dissection (SIRLND) required for
patients = 10 years of age with paratesticular tumors and for patients < 10 years
with clinically or radiographically involved lymph nodes
- Patients with extensive lymph node involvement, defined as = 2 lymph nodes > 2
cm in dimension, identified by imaging studies, are not required to undergo
SIRLND
- Regional lymph node sampling or sentinel lymph node procedure is required for
histologic evaluation in patients with extremity tumors
- Has undergone initial surgery or biopsy within the past 42 days
- Must be able to undergo radiotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 (Karnofsky PS 50-100% [= 16 years of age] or Lansky
PS 50-100% [< 16 years of age])
- Absolute neutrophil count = 750/mm^3
- Platelet count = 75,000/mm^3 (transfusion independent)
- Bilirubin = 1.5 times upper limit of normal (ULN)
- Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min (40
mL/min for infants < 1 year of age)
- Patients with urinary tract obstruction by tumor must have unimpeded urinary flow
established via decompression of the obstructed portion of the urinary tract
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for = 1 month after
completion of study treatment
- No evidence of uncontrolled infection
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy* (excluding steroids)
- No prior radiotherapy*
- No concurrent aprepitant during treatment with cyclophosphamide NOTE: *Patients who
received prior radiotherapy or chemotherapy while enrolled on COG-ARST0331 allowed
Link
|
Sponsors:
|
Children's Oncology Group; National Cancer Institute (NCI) |
| Dates: |
July 19, 2006 |
| Last Updated: |
December 2, 2010 |
| Study HIC#: |
1008007246 |
| Clinicaltrials.gov ID: |
NCT00354835
|
Sign in
Create a Profile
Previous
