Clinical trial · Interventional

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

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

NCT00002641CI-TRIAL-00015352completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Endometrial Cancer	Malignant Endometrial Neoplasm	CURATED_BROADER	0.80
Kidney Cancer	Malignant Kidney Neoplasm	CURATED_EXACT	0.92
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Pheochromocytoma	Adrenal Gland Pheochromocytoma	ALIAS	0.90
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
adjuvant therapy	Procedure	—	UNRESOLVED
conventional surgery	Procedure	—	UNRESOLVED
doxorubicin hydrochloride	Drug	Doxorubicin	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
ifosfamide	Drug	Ifosfamide	ALIAS
isolated perfusion	Drug	—	UNRESOLVED
radiation therapy	Radiation	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 16 Years
Maximum age: 69 Years

Show eligibility criteria text

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

References

Publications (2)

BACKGROUNDLe 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.
DERIVEDWoll 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. PMID 22954508

Registry

Dates and enrollment

Start: Feb 1, 1995
Primary completion: Feb 1, 2006
Completion: Jun 1, 2012
First posted: Jan 27, 2003
Last update posted: Aug 8, 2014
Enrollment: 350 (estimated)
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC NETWORK
Collaborators: NCIC Clinical Trials Group
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, uterine carcinosarcoma, uterine leiomyosarcoma, endometrial stromal sarcoma, ovarian sarcoma, clear cell sarcoma of the kidney, stage II adult soft tissue sarcoma

Data updated 22 days agoSource updated Aug 8, 2014source: clinicaltrials

Locations

Country	Sites	Recruiting
Canada	11	0
United Kingdom	8	0
Germany	5	0
Belgium	5	0
Switzerland	3	0
Netherlands	3	0
France	3	0
Denmark	2	0
Portugal	1	0
Spain	1	0
Italy	1	0
Slovakia	1	0
Austria	1	0