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Endometrial CancerPhase 3NCT00002641

Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma

A Phase 3 study testing filgrastim, doxorubicin hydrochloride and ifosfamide in people with Endometrial Cancer and Kidney Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 45 sites in 13 countries.

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

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma. Read more about this study

Who is it for?
Ages 16 to 69 years
Conditions the study is for
Endometrial Cancer, Kidney Cancer, Ovarian Cancer
What is being tested?
filgrastim, doxorubicin hydrochloride and ifosfamide
Type of treatment
Surgery or procedure
How many people
350 participants
Where
45 sitesin 13 countries
Study dates
Feb 1995to Jun 2012
Phase
Phase 3
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 16 to 69 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven soft tissue sarcoma that is amenable to definitive surgery no more than 8 weeks after biopsy or inadequate surgery
  • Eligible subtypes:
  • Alveolar soft part sarcoma
  • Angiosarcoma
  • Fibrosarcoma
  • Leiomyosarcoma
  • Malignant fibrous histiocytoma
  • Liposarcoma (round cell and pleomorphic)
  • Miscellaneous sarcoma (including pelvic mixed mesodermal tumors)
  • Malignant paraganglioma
  • Neurogenic sarcoma
  • Rhabdomyosarcoma
  • Synovial sarcoma
  • Unclassifiable sarcoma
  • Ineligible subtypes:
  • Chondrosarcoma
  • Dermatofibrosarcoma
  • Embryonal rhabdomyosarcoma
  • Ewing's sarcoma
  • Kaposi's sarcoma
  • Liposarcoma (myxoid and well differentiated)
  • Malignant mesothelioma
  • Neuroblastoma
  • Osteosarcoma
  • Confirmed high-grade tumor (i.e., Trojani Grade II or III)
  • No metastases on staging with chest x-ray and thoracic CT scan
  • No regional lymph node involvement
  • Locally recurrent disease allowed
  • Interval of 3 months or more between definitive surgery and recurrence

PATIENT CHARACTERISTICS:

Age:

  • 16 to 69

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 120,000/mm^3
  • No bleeding disorders

Hepatic:

  • Bilirubin no greater than 1.25 times normal
  • No severe hepatic dysfunction

Renal:

  • Creatinine less than 1.6 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No clear history of angina
  • No documented myocardial infarction
  • No existing cardiac failure

Other:

  • No serious infection
  • No other malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to affected area

Surgery:

  • See Disease Characteristics

Trial locations and contacts

45 sites in 13 countries.

45 sites in 13 countries

Canada11 sites

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Cancer Care Ontario-Hamilton Regional Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Cancer Care Ontario-London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

  • McGill University

    Montreal, Quebec, H2W 1S6

  • Ottawa Regional Cancer Centre

    Ottawa, Ontario, K1H 1C4

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Mount Sinai Hospital - Toronto

    Toronto, Ontario, M5G 1X5

  • British Columbia Cancer Agency - Vancouver Island Cancer Centre

    Victoria, British Columbia, V8R 6V5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United Kingdom8 sites

  • Royal Devon and Exeter Hospital

    Exeter, England, EX2 5DW

  • St. James's Hospital

    Leeds, England, LS9 7TF

  • Royal Marsden NHS Trust - London

    London, England, SW3 6JJ

  • Middlesex Hospital- Meyerstein Institute

    London, England, WIT 3AA

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 4BX

  • Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Weston Park Hospital

    Sheffield, England, S1O 2SJ

Other trials in United Kingdom

Belgium5 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Germany5 sites

  • Robert Roessle Klinik

    Berlin, D-13122

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Universitaets-Krankenhaus Eppendorf

    Hamburg, D-20246

  • Klinikum Grosshadern

    Munich, D-81377

  • Eberhard Karls Universitaet

    Tübingen, D-72076

Other trials in Germany

France3 sites

  • Centre Leon Berard

    Lyon, 69373

  • CHU de la Timone

    Marseille, 13385

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Netherlands3 sites

  • Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

  • Daniel Den Hoed Cancer Center at Erasmus University Medical Center

    Rotterdam, 3075 EA

Other trials in Netherlands

Switzerland3 sites

  • Inselspital, Bern

    Bern, CH-3010

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • Kantonsspital - St. Gallen

    Sankt Gallen, CH-9007

Other trials in Switzerland

Denmark2 sites

  • Aarhus Kommunehospital

    Aarhus, DK-8000

  • Rigshospitalet

    Copenhagen, 2100

Other trials in Denmark

Austria1 site

  • Karl-Franzens-University Graz

    Graz, A-8010

Other trials in Austria

Italy1 site

  • Istituto Nazionale per lo Studio e la Cura dei Tumori

    Milano (Milan), 20133

Other trials in Italy

Portugal1 site

  • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

    Lisbon, 1099-023 Codex

Other trials in Portugal

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

Spain1 site

  • Hospital de la Santa Cruz I Sant Pau

    Barcelona, 08025

Other trials in Spain

About this study

Official title: RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have soft tissue sarcoma.

Read the detailed description

OBJECTIVES:

  • Compare the local disease control, overall survival, and relapse-free survival in patients with high-grade soft tissue sarcoma treated with adjuvant high-dose doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and G-CSF after definitive surgery.
  • Compare the toxicity and morbidity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head, or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no).

Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines.

No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive surgery. Patients with complete resection undergo radiotherapy assessment and then randomization. Patients with incomplete or marginal resection (except for central lesions) undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative radiotherapy followed by randomization.

  • Randomization: Patients are randomized to 1 of 2 treatment arms.
  • Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined below.
  • Arm II: Beginning within 4 weeks after surgery, patients receive high-dose doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF subcutaneously daily beginning 24 hours after completion of ifosfamide infusion and continuing for 10 days. Treatment continues every 3 weeks for 5 courses. Beginning within 6 weeks after completion of chemotherapy, eligible patients undergo radiotherapy as outlined below.
  • Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5 days a week for 6-6.6 weeks. Patients with complete microscopic resection undergo radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for 1 week.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.

Keywords
adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, stage III adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult alveolar soft-part sarcoma, adult epithelioid sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult malignant mesenchymoma, adult rhabdomyosarcoma, localized benign pheochromocytoma, regional pheochromocytoma, recurrent pheochromocytoma, stage II uterine sarcoma, stage III uterine sarcoma, recurrent uterine sarcoma
Medical subject headings
Endometrial Neoplasms, Kidney Neoplasms, Ovarian Neoplasms, Pheochromocytoma, Sarcoma, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma

What participants receive

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

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 1995
  3. Primary completionFeb 2006
  4. Study completionJun 2012

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 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002641
Sponsor's protocol ID
EORTC-62931
Other IDs
EORTC-62931, CAN-NCIC-SR3
Status last verified
Jul 2002
First submitted
1 Nov 1999
Last updated
8 Aug 2014
Results posted
No

Publications

  • Le Cesne A, Van Glabbeke M, Woll PJ, et al.: The end of adjuvant chemotherapy (adCT) era with doxorubicin-based regimen in resected high-grade soft tissue sarcoma (STS): pooled analysis of the two STBSG-EORTC phase III clinical trials. [Abstract] J Clin Oncol 26 (Suppl 15): A-10525, 2008.

  • Woll PJ, Reichardt P, Le Cesne A, Bonvalot S, Azzarelli A, Hoekstra HJ, Leahy M, Van Coevorden F, Verweij J, Hogendoorn PC, Ouali M, Marreaud S, Bramwell VH, Hohenberger P; EORTC Soft Tissue and Bone Sarcoma Group and the NCIC Clinical Trials Group Sarcoma Disease Site Committee. Adjuvant chemotherapy with doxorubicin, ifosfamide, and lenograstim for resected soft-tissue sarcoma (EORTC 62931): a multicentre randomised controlled trial. Lancet Oncol. 2012 Oct;13(10):1045-54. doi: 10.1016/S1470-2045(12)70346-7. Epub 2012 Sep 4.

    PubMed 22954508

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, doxorubicin hydrochloride and ifosfamide in people with Endometrial Cancer and Kidney Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 45 sites in 13 countries.

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

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Canada, United Kingdom, Belgium, Germany, France and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT00002641, which also lists 2 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 8 Aug 2014.

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