Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002791
First received: November 1, 1999
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed by surgery in treating patients who have soft tissue sarcoma.


Condition Intervention Phase
Sarcoma
Biological: filgrastim
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: mesna
Procedure: conventional surgery
Radiation: brachytherapy
Radiation: intraoperative radiation therapy
Radiation: radioisotope therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A PHASE II STUDY OF NEOADJUVANT CHEMOTHERAPY AND RADIATION THERAPY IN THE MANAGEMENT OF HIGH-RISK, HIGH-GRADE, SOFT TISSUE SARCOMAS OF THE EXTREMITIES AND BODY WALL

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Study Start Date: February 1997
Study Completion Date: November 2013
Primary Completion Date: May 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Assess whether patients with high-grade soft tissue sarcoma (STS) treated with neoadjuvant mesna/doxorubicin/ifosfamide/dacarbazine (MAID) plus radiotherapy in a cooperative group setting exhibit a response rate, toxicity, and complication rate comparable to those seen in pilot data collected by the Massachusetts General Hospital. II. Assess local control and local complications related to surgery and neoadjuvant MAID plus radiotherapy in these patients. III. Develop a tissue repository of frozen STS for ancillary genetic and flow cytometric analysis of these tumors. IV. Form an Intergroup Working Sarcoma Group that will develop a patient base, relationships, and support for the future development and completion of a phase III study of adjuvant therapy for STS.

OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 DTIC Dacarbazine, NSC-45388 EBRT External-Beam Radiotherapy (equipment unspecified) G-CSF Filgrastim; Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 MAID Mesna/DOX/IFF/DTIC Mesna Mercaptoethane sulfonate, NSC-113891 3-Drug Combination Chemotherapy plus Radiotherapy followed by Surgery followed, if indicated, by Radiotherapy followed by 3-Drug Combination Chemotherapy. MAID; plus EBRT to the primary tumor and suspected microscopic disease; followed by minimal wide surgical excision; followed, if positive margins, by postoperative EBRT; followed by MAID.

PROJECTED ACCRUAL: There will be 60 patients accrued into this study within 15 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed soft tissue sarcoma of an extremity or the body wall that is a primary or a postoperatively recurrent tumor Biopsy required within 2 months prior to entry Grade II or III tumor, including AJCC stages IIB and IIIB lesions at least 8 cm in diameter No more than 4 chest lesions that are no greater than 3 mm in diameter on preoperative CT The following histologies are excluded: Angiosarcoma of the scalp or face Chondrosarcoma Extraosseous Ewing's sarcoma Head and neck sarcoma Kaposi's sarcoma Osteosarcoma Primitive neuroectodermal tumor Rhabdomyosarcoma Patients on this study are also eligible for Frozen Tumor Repository study (protocol RTOG-9308)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 50 U Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No congestive heart failure (CHF) within 6 months No myocardial infarction (MI) within 6 months No New York Heart Association class II-IV heart disease Left ventricular ejection fraction at least 50% by MUGA or echocardiogram If history of CHF or MI, criterion must be met within past 6 months Other: No contraindication to surgery No uncontrolled bacterial, viral, or fungal infection No serious medical or psychiatric illness that precludes informed consent or limits survival to less than 2 years No second malignancy within 5 years except: Surgically treated in situ cervical cancer Nonmelanomatous skin cancer Not pregnant or nursing Negative pregnancy test required of fertile women within 7 days prior to entry Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002791

  Show 237 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Eastern Cooperative Oncology Group
Investigators
Study Chair: William G. Kraybill, MD, FACS Roswell Park Cancer Institute
Study Chair: Ronald H. Blum, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Kraybill WG, Harris JH, Spiro I, et al.: Radiation Therapy Oncology Group (RTOG) 9514: a phase II study of neoadjuvant chemotherapy (CT) and radiation therapy (RT) in the management of high risk (HR), high grade, soft tissue sarcomas (STS) of the extremities and body wall. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3276, 2003.
Kraybill WG, Spiro I, Harris J, et al.: Radiation Therapy Oncology Group (RTOG) 95-14: a phase II study of neoadjuvant chemotherapy (CT) and radiation therapy (RT) in high risk (HR), high grade, soft tissue sarcomas (STS) of the extremities and body wall: a preliminary report. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1387, 2001.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002791     History of Changes
Other Study ID Numbers: RTOG-9514, CDR0000064856, E-R9514, RTOG-R9514
Study First Received: November 1, 1999
Last Updated: January 23, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage II adult soft tissue sarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014