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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00346164 |
Purpose
RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. It is not yet known which regimen is more effective in treating soft tissue sarcoma.
PURPOSE: This phase III trial is studying observation to see how well it works compared with radiation therapy, combination chemotherapy, and/or surgery in treating patients with soft tissue sarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Childhood Malignant Fibrous Histiocytoma of Bone Sarcoma |
Drug: doxorubicin hydrochloride Drug: ifosfamide Procedure: observation Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age |
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2007 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Experimental
(Low risk [nonmetastatic, grossly resected disease, except high-grade tumor > 5 cm]): Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to receive regimen A (observation only). Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to receive regimen B (beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy).
|
Procedure: observation
Patients undergo observation
Radiation: radiation therapy
Patients undergo radiotherapy
|
|
Group 2: Experimental
(Intermediate risk [nonmetastatic, resected high-grade tumor > 5 cm or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to receive regimen C (adjuvant chemoradiotherapy) for approximately 19 weeks. Patients with unresected tumor are assigned to receive regimen D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy) lasting approximately 25 weeks.
|
Drug: doxorubicin hydrochloride
Given IV
Drug: ifosfamide
Given IV
Procedure: therapeutic conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
|
|
Group 3: Experimental
(High risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with low-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in group 2 regimen D.
|
Drug: doxorubicin hydrochloride
Given IV
Drug: ifosfamide
Given IV
Procedure: observation
Patients undergo observation
Procedure: therapeutic conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 29 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902
Meets 1 of the following criteria:
Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:
Adipocytic tumor, including liposarcoma of any of the following histology subtypes:
Fibroblastic/myofibroblastic tumors, including any of the following:
So-called fibrohistiocytic tumors, including any of the following:
Chondro-osseous tumors of any of the following types:
Tumors of uncertain differentiation, including any of the following:
Dermatofibrosarcoma protuberans meeting both of the following criteria:
Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply:
High-grade tumor with metastases
Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes*
PATIENT CHARACTERISTICS:
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 153 Study Locations| Study Chair: | Sheri L. Spunt, MD | St. Jude Children's Research Hospital |
| Investigator: | Karyn A. Goodman, MD | Stanford University |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000483702, COG-ARST0332 |
| Study First Received: | June 28, 2006 |
| Last Updated: | November 5, 2009 |
| ClinicalTrials.gov Identifier: | NCT00346164 History of Changes |
| Health Authority: | Unspecified |
|
adult malignant hemangiopericytoma adult malignant mesenchymoma adult neurofibrosarcoma adult alveolar soft-part sarcoma adult angiosarcoma adult epithelioid sarcoma adult extraskeletal chondrosarcoma adult extraskeletal osteosarcoma adult fibrosarcoma adult leiomyosarcoma adult liposarcoma adult synovial sarcoma childhood alveolar soft-part sarcoma childhood angiosarcoma childhood epithelioid sarcoma |
childhood fibrosarcoma childhood leiomyosarcoma childhood liposarcoma childhood synovial sarcoma dermatofibrosarcoma protuberans metastatic childhood soft tissue sarcoma nonmetastatic childhood soft tissue sarcoma stage I adult soft tissue sarcoma stage II adult soft tissue sarcoma stage III adult soft tissue sarcoma stage IV adult soft tissue sarcoma adult malignant fibrous histiocytoma localized childhood malignant fibrous histiocytoma of bone metastatic childhood malignant fibrous histiocytoma of bone chondrosarcoma |
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Histiocytoma, Malignant Fibrous Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Histiocytoma, Benign Fibrous Antineoplastic Agents Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Neoplasms, Connective and Soft Tissue |
Neoplasms Ifosfamide Histiocytoma Therapeutic Uses Sarcoma Antineoplastic Agents, Alkylating Neoplasms, Connective Tissue Neoplasms, Fibrous Tissue Alkylating Agents |