# Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma

> **NCT02567435** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **National Cancer Institute (NCI)** · enrollment: 325 (actual)

## Conditions studied

- Alveolar Rhabdomyosarcoma
- Botryoid-Type Embryonal Rhabdomyosarcoma
- Embryonal Rhabdomyosarcoma
- Rhabdomyosarcoma
- Sclerosing Rhabdomyosarcoma
- Spindle Cell Rhabdomyosarcoma

## Interventions

- **DRUG:** Cyclophosphamide
- **BIOLOGICAL:** Dactinomycin
- **DRUG:** Irinotecan Hydrochloride
- **OTHER:** Laboratory Biomarker Analysis
- **OTHER:** Questionnaire Administration
- **RADIATION:** Radiation Therapy
- **DRUG:** Temsirolimus
- **DRUG:** Vincristine Sulfate
- **DRUG:** Vinorelbine

## Key facts

- **NCT ID:** NCT02567435
- **Lead sponsor:** National Cancer Institute (NCI)
- **Sponsor class:** NIH
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2016-06-01
- **Primary completion:** 2023-06-30
- **Final completion:** 2026-10-27
- **Target enrollment:** 325 (ACTUAL)
- **Last updated:** 2026-05-01


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02567435

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02567435, "Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT02567435. Licensed CC0.

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