NCT00001188

Brief Summary

Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 1983

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1983

Completed
15.9 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

November 1, 1999

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Sarcoma

Keywords

ChemotherapyRadiation TherapySarcomaSurgery

Interventions

radiation therapy following surgeryPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Patients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses: Liposarcoma (round cell or pleomorphic). Fibrosarcoma. Malignant fibrous histiocytoma. Inflammatory malignant fibrous histiocytoma. Myxoid malignant fibrous histiocytoma. Malignant giant cell tumor. Angiomatoid malignant fibrous histiocytoma. Leiomyosarcoma. Malignant hemangiopericytoma. Rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined). Soft tissue sarcoma resembling Ewing's sarcoma. Synovial cell sarcoma. Epithelioid sarcoma. Clear cell sarcoma. Neurofibrosarcoma. Epithelioid schwannoma. Malignant triton tumor. Angiosarcoma. Mixed malignant mesenchymoma. Alvelar soft part sarcoma. Malignant granular cell tumor. All lesions must be Grade II or III. No patients with Grade I lesions will be acceptable. Patients must have undergone a limb-sparing procedure in which all gross tumor has been removed. Clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites. The soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint. The definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization. Patients must not have received any prior chemotherapy or radiotherapy for their sarcoma. Patients without a history of any other malignant disease except basal cell carcinoma. Patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function. Patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.

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

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Suit HD, Russell WO, Martin RG. Sarcoma of soft tissue: clinical and histopathologic parameters and response to treatment. Cancer. 1975 May;35(5):1478-83. doi: 10.1002/1097-0142(197505)35:53.0.co;2-1.

    PMID: 1122498BACKGROUND

  • Lindberg RD, Martin RG, Romsdahl MM, Barkley HT Jr. Conservative surgery and postoperative radiotherapy in 300 adults with soft-tissue sarcomas. Cancer. 1981 May 15;47(10):2391-7. doi: 10.1002/1097-0142(19810515)47:103.0.co;2-b.

    PMID: 7272893BACKGROUND

  • McNeer GP, Cantin J, Chu F, Nickson JJ. Effectiveness of radiation therapy in the management of sarcoma of the soft somatic tissues. Cancer. 1968 Aug;22(2):391-7. doi: 10.1002/1097-0142(196808)22:23.0.co;2-q. No abstract available.

    PMID: 4298242BACKGROUND

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

December 1, 1983

Study Completion

September 1, 2000

Last Updated

March 4, 2008

Record last verified: 1999-11

Locations

US(1)