A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)
Anus | Breast - Female | Breast - Male | Colon | Corpus Uteri | Esophagus | Eye and Orbit | Kidney | Larynx | Lip, Oral Cavity and Pharynx | Liver | Lung | Melanoma, skin | Other Digestive Organ | Other Endocrine System | Other Female Genital | Other Male Genital | Other Respiratory and Intrathoracic Organs | Other Skin | Other Urinary | Ovary | Pancreas | Prostate | Rectum | Small Intestine | Soft Tissue | Stomach | Thyroid | Pediatrics | Cervix | Urinary Bladder
What is the purpose of this trial?
This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma.
- Trial withChildren's Oncology Group (The)
- Start Date03/18/2018
- End Date10/31/2022
- Last Updated01/25/2019
- Study HIC#1606017917