Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma

City of Hope

Status and phase: Terminated; Phase 2

Conditions: Sarcoma

Treatments: Procedure: therapeutic conventional surgery; Procedure: neoadjuvant therapy; Radiation: intensity-modulated radiation therapy; Genetic: western blotting; Genetic: polymerase chain reaction; Genetic: gene expression analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00740597

CHNMC-07216

P30CA033572 (U.S. NIH Grant/Contract)

07216

CDR0000612344 (Registry Identifier)

Details and patient eligibility

About

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying the side effects of intensity-modulated radiation therapy and to see how well it works in treating patients undergoing surgery for stage IB, stage II, or stage III soft tissue sarcoma.

Full description

OBJECTIVES:

Primary

• Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma (STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT).

Secondary

• Assess local control rate in patients treated with this regimen.
• Assess metastatic failure rate in patients treated with this regimen.
• Assess disease-free survival of patients treated with this regimen.
• Assess overall survival of patients treated with this regimen.
• Assess function and general health in these patients using the Musculoskeletal Tumor Society rating scale, Toronto Extremity Salvage Score, and the Short-Form 36.
• Determine changes in STS gene expression after IMRT by microarray analyses.
• Correlate, preliminarily, changes in STS gene expression with pathological and clinical outcomes.

OUTLINE: Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery > 1 month after completion of IMRT.

Tumor tissue samples are collected at baseline and at the time of surgery for correlative laboratory studies. Samples are analyzed for gene expression by RNA microarray, real-time polymerase chain reaction, and western blotting.

After completion of study treatment, patients are followed periodically for 2 years.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care

  • Stage IB-III disease
  • Primary or locally recurrent disease

• The following chemotherapy-sensitive STS histologies are excluded:

  • Primitive neuroectodermal tumor
  • Desmoplastic small round cell tumor
  • Synovial sarcoma
  • Myxoid round cell liposarcoma
  • Angiosarcoma

• No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma)

• No retroperitoneal STS

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Able to complete the self-assessment questionnaires (may use translator service)
• Willing and able to undergo pre-treatment core needle biopsies
• Negative pregnancy test
• No known HIV positivity

PRIOR CONCURRENT THERAPY:

• Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease

  • At least 1 year since prior adjuvant chemotherapy

• No prior radiotherapy to the site of present STS

• No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Arm 1

Experimental group

Description:

pre-operative radiation + surgery PTV will receive a total dose of 50 Gy in 25 fractions, 2 Gy per fraction, 5 fractions per week, over approximately 5 weeks. Concurrently, the GTV2, if present, will receive 54 Gy in 25 fraction. Dose will be prescribed to the isodose volume that encompasses the PTV. All patients will be treated by 6 MV photon beam.

Treatment:

Genetic: western blotting

Procedure: neoadjuvant therapy

Radiation: intensity-modulated radiation therapy

Procedure: therapeutic conventional surgery

Genetic: gene expression analysis

Genetic: polymerase chain reaction