SarcomaPhase 2NCT00001189
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
A Phase 2 study testing radiotherapy in people with Sarcoma and Neoplasms, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1983to Apr 2001
- 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
DISEASE CHARACTERISTICS:
Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:
Abdominal and extra-abdominal fibromatosis (desmoid,
aggressive fibromatosis),
Dermatofibrosarcoma protuberans,
Intramuscular lipoma (infiltrating lipoma),
Diffuse lipomatosis,
Leiomyoma of deep soft tissue,
Diffuse giant cell tumor of tendon sheath (proliferative synovitis).
No clinical evidence of metastases in regional nodes or more distant sites.
No primary intraperitoneal or retroperitoneal tumors.
Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).
No von Recklinghausen's disease.
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy: No prior chemotherapy for sarcoma.
Endocrine Therapy: Not specified.
Radiotherapy: No prior radiotherapy for sarcoma.
Surgery: No more than 4 months since definitive surgery for
primary lesion or recurrence.
No prior amputation.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: Not specified.
Hematopoietic: Not specified.
Hepatic: No cirrhosis.
Renal: No evidence of severe renal impairment.
Cardiovascular: No ischemic heart disease.
OTHER:
No prior malignancy except basal cell carcinoma.
No serious infection.
No active bleeding disorder.
No severe concomitant disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.
Read the detailed description
This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.
Arm I: Radiotherapy. Involved-field irradiation.
Arm II: No further treatment.
- Being tested
- radiotherapy
- Keywords
- Adjuvant Radiotherapy, Low-Grade Sarcoma, Radiotherapy, Randomized Study, Sarcoma, Surgery
- Medical subject headings
- Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiotherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startDec 1983
- Study completionApr 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001189
- Sponsor's protocol ID
- 830227
- Other IDs
- 83-C-0227
- Status last verified
- May 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Wara WM, Phillips TL, Hill DR, Bovill E Jr, Luk KH, Lichter AS, Leibel SA. Desmoid tumors--treatment and prognosis. Radiology. 1977 Jul;124(1):225-6. doi: 10.1148/124.1.225.
PubMed 405711
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
- ClinicalTrials.gov ID
- NCT00001189
- Acronym / sponsor ID
- 830227
- Keywords
- Adjuvant Radiotherapy, Low-Grade Sarcoma, Radiotherapy, Randomized Study, Sarcoma, Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Dec 1983
- Study completion
- Apr 2001
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue tumors will receive wide local excision and be prospectively randomized as to either receive or not receive radiation therapy.
Detailed description
This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.
Arm I: Radiotherapy. Involved-field irradiation.
Arm II: No further treatment.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiotherapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 405711Wara WM, Phillips TL, Hill DR, Bovill E Jr, Luk KH, Lichter AS, Leibel SA. Desmoid tumors--treatment and prognosis. Radiology. 1977 Jul;124(1):225-6. doi: 10.1148/124.1.225.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiotherapy in people with Sarcoma and Neoplasms, 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 NCT00001189, which also lists 1 linked publication.
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.