NCT00003958

Brief Summary

This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well each works in treating patients with previously untreated rhabdomyosarcoma or sarcoma. Drugs used in chemotherapy, such as dactinomycin, cyclophosphamide, vincristine, and topotecan, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective in treating rhabdomyosarcoma.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
702

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.8 years until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

5.1 years

First QC Date

November 1, 1999

Last Update Submit

June 13, 2013

Conditions

Adult Malignant MesenchymomaAdult RhabdomyosarcomaAlveolar Childhood RhabdomyosarcomaChildhood Malignant MesenchymomaEmbryonal Childhood RhabdomyosarcomaEmbryonal-botryoid Childhood RhabdomyosarcomaNonmetastatic Childhood Soft Tissue SarcomaPreviously Untreated Childhood RhabdomyosarcomaStage I Adult Soft Tissue SarcomaStage II Adult Soft Tissue SarcomaStage III Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Long-term failure-free survival (FFS) between the two treatment groups

    Up to 5 years

Secondary Outcomes (4)

  • Overall survival between treatments

    Up to 5 years

  • Rate of second look surgery

    Week 12

  • Proportion of patients rendered tumor-free or with microscopic tumor only

    Week 12

  • Estimation of the rate of local failure for the patients who undergo second look surgery

    Week 12

Study Arms (2)

Arm I

EXPERIMENTAL

Vincristine sulfate IV once a wk on wks 0-12, 15, 18-24, 27, 30-36, and 39. Dactinomycin IV once a wk on wks 0, 3, 6, 9, 12, 21, 24, 27, 30, 33, 36, and 39. Cyclophosphamide IV once a wk on wks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, and 39. After 12 weeks of chemotherapy, depending on tumor shrinkage, pts may undergo surgery. After recovery from therapeutic conventional surgery, patients receive radiation therapy once a day, 5 days a wk, during wks 12-18. For pt receiving radiotherapy during wks 0-6, dactinomycin is omitted during wks 3 and 6 and during wks 15 and 18. For patients receiving radiotherapy during wks 12-18, dactinomycin is omitted during wks 15 and 18. Patients with adequate response at wk 24 continue chemotherapy during wks 24-39. All pts receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.

Biological: dactinomycinDrug: vincristine sulfateDrug: cyclophosphamideProcedure: therapeutic conventional surgeryRadiation: radiation therapyBiological: filgrastimBiological: sargramostimOther: laboratory biomarker analysis

Arm II

EXPERIMENTAL

Patients receive treatment as in arm I, except dactinomycin is replaced with topotecan hydrochloride IV over 15-30 minutes daily for 5 days during weeks 3, 9, 21, 27, 33, and 39. All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 hours after completion of each course of chemotherapy and continuing 1 year, until hematopoietic recovery.

Drug: vincristine sulfateDrug: cyclophosphamideProcedure: therapeutic conventional surgeryRadiation: radiation therapyDrug: topotecan hydrochlorideBiological: filgrastimBiological: sargramostimOther: laboratory biomarker analysis

Interventions

dactinomycinBIOLOGICAL

Given IV

Also known as: ACT-D, actinomycin C1, AD, Cosmegen, DACT
Arm I
vincristine sulfateDRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS
Arm IArm II
cyclophosphamideDRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Arm IArm II
therapeutic conventional surgeryPROCEDURE

Undergo surgery

Arm IArm II
radiation therapyRADIATION

Undergo radiotherapy

Also known as: irradiation, radiotherapy, therapy, radiation
Arm IArm II
topotecan hydrochlorideDRUG

Given IV

Also known as: hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Arm II
filgrastimBIOLOGICAL

Given SC

Also known as: G-CSF, Neupogen
Arm IArm II
sargramostimBIOLOGICAL

Given SC

Also known as: GM-CSF, Leukine, Prokine
Arm IArm II
laboratory biomarker analysisOTHER

Correlative studies

Arm IArm II

Eligibility Criteria

AgeUp to 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically proven disease of any of the following types:
  • Non metastatic alveolar rhabdomyosarcoma
  • Stage I, II, or III; Clinical Group I, II, or III
  • Stage II or III, Clinical Group III embryonal rhabdomyosarcoma
  • Botryoid
  • Spindle cell
  • Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma
  • Botryoid
  • Spindle cell
  • Undifferentiated sarcoma
  • Stage I, II, or III; Clinical Group I, II, or III
  • Ectomesenchymoma
  • Stage I, II, or III; Clinical Group I, II, or III, with alveolar features
  • Under 10 years, Stage IV, Clinical Group IV, with embryonal features
  • No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the definitive diagnosis
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Malignant mesenchymal tumorRhabdomyosarcomaSarcoma

Interventions

DactinomycinVincristineCyclophosphamideRadiotherapyRadiationTopotecantrioctyl phosphine oxideFilgrastimGranulocyte Colony-Stimulating FactorsargramostimGranulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

MyosarcomaNeoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingIndolizidinesIndolizinesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsTherapeuticsPhysical PhenomenaCamptothecinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsProteinsBiological Factors

Study Officials

  • Carola Arndt

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

October 1, 2007

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

US(1)