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

NCT00740597 | Terminated Phase 2 Results DMC

• 4 other identifiers: 07216P30CA033572CHNMC-07216CDR0000612344
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcoma

Keywords

recurrent adult soft tissue sarcoma; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma; adult alveolar soft-part sarcoma; adult epithelioid sarcoma; adult extraskeletal chondrosarcoma; adult extraskeletal osteosarcoma; adult fibrosarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult malignant mesenchymoma; adult neurofibrosarcoma; adult rhabdomyosarcoma; dermatofibrosarcoma protuberans

Outcome Measures

Primary Outcomes (1)

• Wound Complication Rate

  Major wound complications up to 4 months post surgery include: Complications requiring a secondary operation under general or regional anesthesia for wound care. Seroma aspiration. Drain placement. Minor wound debridement and wound care. Readmission for wound care such as intravenous antibiotics. Persistent wound deep packing or wound vacuum assisted closure for greater than 120 days.

  1 year

Study Arms (1)

Arm 1

EXPERIMENTAL

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.

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

Interventions

gene expression analysis GENETIC

Arm 1

polymerase chain reaction GENETIC

Arm 1

western blotting GENETIC

Arm 1

neoadjuvant therapy PROCEDURE

Arm 1

therapeutic conventional surgery PROCEDURE

Arm 1

intensity-modulated radiation therapy RADIATION

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Sarcoma; Sarcoma, Alveolar Soft Part; Chondrosarcoma, Extraskeletal Myxoid; Fibrosarcoma; Histiocytoma, Malignant Fibrous; Hemangiopericytoma, Malignant; Malignant mesenchymal tumor; Neurofibrosarcoma; Rhabdomyosarcoma; Dermatofibrosarcoma

Interventions

Gene Expression Profiling; Polymerase Chain Reaction; Blotting, Western; Neoadjuvant Therapy; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Histiocytoma; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Myosarcoma

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; Electrophoresis; Chemistry Techniques, Analytical; Electrochemical Techniques; Immunoblotting; Immunoassay; Immunologic Techniques; Molecular Probe Techniques; Combined Modality Therapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy

Limitations and Caveats

Study closed 05/12/2010 (opened 7/25/2008): No patients were accrued and treated per protocol in nearly two years (2 patients were screened). The study was terminated by the IRB when the PI decided not to continue. Protocol objectives were not met.

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope National Medical Center

pfrankel@coh.org

(626)359-8111

Study Officials

• Richard D. Pezner, MD

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2008
• First Posted: August 25, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 11, 2014
• Results First Posted: July 11, 2014

Record last verified: 2014-06

Locations

US (1)