RMS13: Chemotherapy, Surgery and Proton Beam Radiation Therapy in Treating Patients with Newly Diagnosed Rhabdomyosarcoma

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Participants with Low-, Intermediate- and High-Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Rhabdomyosarcoma (low-risk, intermediate-risk and high-risk)

Eligibility Overview:

  • Newly diagnosed rhabdomyosarcoma
  • Younger than 22 years (eligible until 22nd birthday)
  • No previous treatment with chemotherapy or radiation therapy
  1. Brief Summary

    This Phase II, multi-center trial will treat participants with newly diagnosed, low, intermediate and high risk rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified dose chemotherapy, proton beam radiation and surgical resection. Intermediate and high risk participants will receive an additional 12 weeks (4 cycles) of maintenance therapy with anti-angiogenic chemotherapy.

    Objectives

    The study aims to improve disease control outcomes while minimizing late effects specific to radiation therapy in participants. 

    Primary Objective

    • To estimate event-free survival for intermediate risk participants treated by vincristine, dactinomycin and cyclophosphamide (VAC) with the addition of maintenance anti-angiogenic therapy

    Eligibility Criteria

    Inclusion criteria include:

    • Newly diagnosed, previously untreated with rhabdomyosarcoma (RMS)
    • Low-risk, intermediate-risk or high-risk disease
    • Younger than 22 years  (eligible until 22nd birthday)
    • ECOG score of 0, 1 or 2 for patients age 16 and older
    • Lansky Performance Score ≥ 50 for patients younger than 16
    • No prior radiotherapy or chemotherapy (excluding steroids) Note: Prior biopsy, surgical resection, and lymph node sampling are allowed.
    • Initiation of chemotherapy is planned within six weeks (42 days) of the definitive biopsy or surgical resection
    • No evidence of active, uncontrolled infection

    Exclusion criteria include:

    • Pregnancy or breast feeding

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee
    Collaborating sites in the U.S.

  2. About this study

    Rhabdomyosarcoma (RMS) is a type of cancer that occurs in the soft tissue of the body, such as in the muscles. The standard treatment for RMS is a combination of chemotherapy (treatment with anti-cancer drugs), plus surgery and/or radiation therapy (the use of high-energy X-rays to kill cancer cells).

    In this study, researchers will assign participants to one of three risk groups: low-risk, intermediate- risk, or high-risk.  The term “risk” refers to the chance of the tumor coming back after treatment. The risk will be determined by the tumor’s location, size, whether it has spread to the lymph nodes and whether it can be removed with surgery.

    Purpose of this clinical trial

    The doctors in this study want to find out the most effective treatment with the least amount of therapy that will still cure participants with low-risk rhabdomyosarcoma. They also want to know if adding maintenance chemotherapy will benefit participants with intermediate-risk or high-risk tumors by delaying or preventing recurrence of their tumors. 

    Eligibility overview

    • Newly diagnosed or previously untreated with rhabdomyosarcoma (RMS)
    • Low-risk, intermediate-risk or high-risk disease Younger than 22 years (eligible until 22nd birthday)
    • ECOG score of 0, 1 or 2 for patients 16 and older
    • Lansky Performance Score ≥ 50 for patients younger than 16
    • No prior radiotherapy or chemotherapy (excluding steroids) Note: Prior biopsy, surgical resection, and lymph node sampling are allowed.
    • Initiation of chemotherapy is planned within six weeks (42 days) of the definitive biopsy or surgical resection
    • No evidence of active, uncontrolled infection
  3. RMS13  Quick View
    Sponsor St. Jude Children's Research Hospital
    Clinicaltrials.gov identifier NCT01871766
    Trial start date December 2013
    Estimated enrollment 100
    Study type Interventional
    Study phases Phase II
    Conditions

    Rhabdomyosarcoma

    Ages Younger than 22 years
    Principal investigator Matthew Krasin, MD
    Study sites St. Jude and collaborating sites in the U.S.
    For a consultation or to discuss RMS13 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Matthew Krasin, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.