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SarcomaPhase 2NCT00001188

The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities

A Phase 2 study testing radiation therapy following surgery in people with Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Sarcoma
What is being tested?
radiation therapy following surgery
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteUnited States
Study dates
Dec 1983to Sep 2000
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Cancer Institute (NCI)

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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.

Read the detailed description

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.

Conditions
Sarcoma
Being tested
radiation therapy following surgery
Keywords
Chemotherapy, Radiation Therapy, Sarcoma, Surgery
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiation therapy following surgeryProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2002 (estimated)
  2. Study startDec 1983
  3. Study completionSep 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001188
Sponsor's protocol ID
830212
Other IDs
83-C-0212
Status last verified
Nov 1999
First submitted
3 Nov 1999
Last updated
4 Mar 2008
Results posted
No

Publications

  • 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.

    PubMed 1122498

  • 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.

    PubMed 7272893

  • 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.

    PubMed 4298242

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiation therapy following surgery in people with Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001188, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.

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