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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

November 1, 1999
January 23, 2014
February 1997
May 2002   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002791 on ClinicalTrials.gov Archive Site
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Not Provided
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Chemotherapy Plus Radiation Therapy Followed by Surgery in Treating Patients With Soft Tissue Sarcoma
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

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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
Sarcoma
  • Biological: filgrastim
  • Drug: dacarbazine
  • Drug: doxorubicin hydrochloride
  • Drug: ifosfamide
  • Drug: mesna
  • Procedure: conventional surgery
  • Radiation: brachytherapy
  • Radiation: intraoperative radiation therapy
  • Radiation: radioisotope therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2013
May 2002   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   South Africa
 
NCT00002791
RTOG-9514, CDR0000064856, E-R9514, RTOG-R9514
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
  • National Cancer Institute (NCI)
  • Eastern Cooperative Oncology Group
Study Chair: William G. Kraybill, MD, FACS Roswell Park Cancer Institute
Study Chair: Ronald H. Blum, MD New York University School of Medicine
Radiation Therapy Oncology Group
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP