Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma
NCT00003958CI-TRIAL-00010730completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Malignant Mesenchymoma | — | UNRESOLVED | — |
| Adult Rhabdomyosarcoma | Adult Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.98 |
| Alveolar Childhood Rhabdomyosarcoma | Childhood Alveolar Rhabdomyosarcoma | ALIAS | 0.90 |
| Childhood Malignant Mesenchymoma | — | UNRESOLVED | — |
| Embryonal-botryoid Childhood Rhabdomyosarcoma | — | UNRESOLVED | — |
| Embryonal Childhood Rhabdomyosarcoma | Childhood Embryonal Rhabdomyosarcoma | ALIAS | 0.90 |
| Nonmetastatic Childhood Soft Tissue Sarcoma | — | UNRESOLVED | — |
| Previously Untreated Childhood Rhabdomyosarcoma |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dactinomycin | Biological | Dactinomycin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- 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.
- interventionNames
- Biological: dactinomycin
- Drug: vincristine sulfate
- Drug: cyclophosphamide
- Procedure: therapeutic conventional surgery
- Radiation: radiation therapy
- Biological: filgrastim
- Biological: sargramostim
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
* No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial metastases
* Bilirubin no greater than 1.5 mg/dL
* Creatinine normal\* for age
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior chemotherapy
* Prior steroids allowed
* No prior radiotherapy
* See Disease CharacteristicsReferences
Publications (1)
- DERIVEDde Traux de Wardin H, Dermawan JK, Vanoli F, Jiang SC, Singer S, Chi P, Tap W, Wexler LH, Antonescu CR. NF1-Driven Rhabdomyosarcoma Phenotypes: A Comparative Clinical and Molecular Study of NF1-Mutant Rhabdomyosarcoma and NF1-Associated Malignant Triton Tumor. JCO Precis Oncol. 2024 Apr;8:e2300597. doi: 10.1200/PO.23.00597. PMID 38603649