Clinical Trial: Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age

Brief Summary: This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Define a risk-based treatment strategy comprising observation only, adjuvant radiotherapy, or adjuvant chemoradiotherapy or neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy in young patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).

II. Assess event-free and overall survival of patients treated with these regimens.

III. Assess the pattern of treatment failure in these patients.

SECONDARY OBJECTIVES:

I. Assess the feasibility of a neoadjuvant chemoradiotherapy approach in patients with intermediate- or high-risk NRSTS.

II. Assess the imaging and pathologic responses to neoadjuvant chemoradiotherapy in patients with intermediate- or high-risk NRSTS.

III. Correlate imaging and pathologic response with clinical outcomes in patients with intermediate- or high-risk disease who undergo neoadjuvant chemoradiotherapy.

IV. Prospectively define clinical prognostic factors associated with event-free survival, overall survival, local recurrence, and distant recurrence in these patients.

V. Correlate patient outcomes with findings of biologic studies performed on tissue specimens collected on protocol COG-D9902 from these patients.

VI. Determine whether the diagnosis and histologic grade of NRSTS assigned by the enrolling institution correlates with the diagnosis and histologic grade established by central expert pathology reviewers.

  • Long-term survival for low-risk patients [ Time Frame: Up to 5 years ]
    A monitoring boundary located in some sense halfway between the O'Brien-Fleming and Pocock group sequential boundaries to monitor against the expected experience will be used. A procedure adapted from Woolson will be used.
  • Event-free and overall survival for patients in the intermediate risk group [ Time Frame: Up to 5 years ]
    Because the planned therapy for these patients (ifosfamide/doxorubicin chemotherapy and radiotherapy) is presently considered a standard of care, no formal monitoring of event-free or overall survival of these patients is planned.


    • Original Primary Outcome:

    Current Secondary Outcome:

    • Local failure rate [ Time Frame: Up to 5 years follow up ]
      The method of Woolson103 to assess evidence for an unacceptable isolated local failure rate will be used. Evaluation of the isolated local failure rate will take place after 15, 30, and 45 isolated local failures are observed using monitoring p-values of 0.023, 0.052, and 0.070.
    • Toxicity of neoadjuvant chemoradiotherapy [ Time Frame: Until week 13 ]
      A monitoring boundary located halfway between the O'Brien-Fleming and Pocock group sequential boundaries and a spending function approach will be used for interim monitoring of toxicity.


    Original Secondary Outcome:

    Information By: Children's Oncology Group

    Dates:
    Date Received: June 28, 2006
    Date Started: February 2007
    Date Completion:
    Last Updated: September 8, 2014
    Last Verified: September 2014