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Sponsors and Collaborators: |
Radiation Therapy Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002791 |
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 |
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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 II |
Study Type: | Interventional |
Study Design: | 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 |
Study Start Date: | February 1997 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Study Chair: | William G. Kraybill, MD, FACS | Roswell Park Cancer Institute |
Study Chair: | Ronald H. Blum, MD | New York University School of Medicine |
Study ID Numbers: | CDR0000064856, RTOG-9514, E-R9514, RTOG-R9514 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002791 History of Changes |
Health Authority: | United States: Federal Government |
stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma |
Dacarbazine Recurrence Doxorubicin Neoplasms, Connective and Soft Tissue Anti-Bacterial Agents Malignant Mesenchymal Tumor Soft Tissue Sarcomas |
Ifosfamide Sarcoma Antineoplastic Agents, Alkylating Mesna Alkylating Agents Isophosphamide mustard |
Neoplasms by Histologic Type Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antibiotics, Antineoplastic Doxorubicin Pharmacologic Actions |
Neoplasms, Connective and Soft Tissue Neoplasms Ifosfamide Therapeutic Uses Sarcoma Antineoplastic Agents, Alkylating Alkylating Agents |