Clinical trial · Interventional
Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Embryonal Rhabdomyosarcoma
Phase II Trial of Short VAC1.2 Therapy for Low-Risk A Group Patients With Rhabdomyosarcoma
- 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)
RATIONALE: Drugs used in chemotherapy, such as vincristine, dactinomycin, and cyclophosphamide, 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 more than one drug (combination chemotherapy) with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vincristine, dactinomycin, and cyclophosphamide together with or without radiation therapy works in treating patients with embryonal rhabdomyosarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| dactinomycin | Biological | Dactinomycin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Disease-free survival as measured by Kaplan-Meier method 3 years after study entry
Secondary outcomes (4)
- measure
- Overall survival as measured by Kaplan-Meier method 3 years after study entry
- measure
- Progression-free survival as measured by Kaplan-Meier method during events
- measure
- Complete response rate (orbit, group III only) at completion of study treatment
- measure
- Rate of toxicity as measured by NCI-CTC v 2.0 3 years after study entry
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of embryonal rhabdomyosarcoma
* Primary operation for pathological diagnosis within the past 42 days
* The following variants are eligible:
* Botryoid
* Spindle cell
* Anaplastic
* Meets 1 of the following stage criteria:
* Stage I, clinical group I or II (N0), defined by all of the following criteria:
* Favorable site, including orbit, head, and neck (excluding parameningeal sites), genitourinary region (excluding bladder/prostate sites), or biliary tract
* Tumor any size
* Completely resected disease OR microscopic residual disease
* Lymph nodes clinically negative
* Stage I, clinical group III (N0), defined by all of the following criteria:
* Favorable site
* Tumor any size
* Gross residual disease allowed (orbit only)
* Lymph nodes clinically negative
* Stage II, clinical group I (N0, Nx), defined by all of the following criteria:
* Unfavorable site (any sites not listed as favorable sites)
* Tumor ≤ 5 cm in diameter
* Completely resected disease
* Lymph nodes clinically negative OR lymph node involvement unknown
PATIENT CHARACTERISTICS:
Performance status
* 0-3
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 7.5 g/dL
Hepatic
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.5 times ULN
* Bile acid ≤ 2.5 times ULN
Renal
* Creatinine based on age as follows:
* \< 0.8 mg/dL (for patients \< 5 years of age)
* \< 1.2 mg/dL (for patients 5-9 years of age)
* \< 1.5 mg/dL (for patients ≥ 10 years of age)
Cardiovascular
* No severe heart disease
Other
* Not pregnant or nursing
* Must have acceptable organ function for age
* No uncontrolled infection
* No other active malignancy
* No other treated malignancy within the past 5 years
* No hypersensitivity to study drugs
* No Charcot-Marie-Tooth disease
* No chickenpox
PRIOR CONCURRENT THERAPY:
Chemotherapy
* No prior anticancer chemotherapy
Endocrine therapy
* Prior anticancer steroids allowed
Radiotherapy
* No prior radiotherapy
Other
* No concurrent pentostatinReferences
Publications (0)
Data not yet available