NCT00002764

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery plus combination chemotherapy is more effective than surgery alone in treating patients with lung metastases from soft tissue sarcoma. PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P50-P75 for phase_3

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

April 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

4.6 years

First QC Date

November 1, 1999

Last Update Submit

July 10, 2012

Conditions

Endometrial CancerKidney CancerMetastatic CancerOvarian CancerPheochromocytomaSarcoma

Keywords

adult angiosarcomaadult fibrosarcomaadult leiomyosarcomaadult liposarcomaadult neurofibrosarcomaadult synovial sarcomarecurrent adult soft tissue sarcomaadult malignant fibrous histiocytomaadult malignant hemangiopericytomaadult malignant mesenchymomalocalized benign pheochromocytomaregional pheochromocytomalung metastasesstage IV uterine sarcomarecurrent uterine sarcomauterine leiomyosarcomaendometrial stromal sarcomaovarian sarcomaclear cell sarcoma of the kidneystage IV adult soft tissue sarcoma

Interventions

filgrastimBIOLOGICAL
doxorubicin hydrochlorideDRUG
ifosfamideDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven soft tissue sarcoma with pulmonary metastases for which radical metastasectomy is feasible Eligible subtypes: Malignant fibrous histiocytoma Liposarcoma Synovial sarcoma Malignant paraganglioma Fibrosarcoma Leiomyosarcoma Neurogenic sarcoma Unclassified sarcoma Angiosarcoma (including hemangiopericytoma) Miscellaneous sarcoma (including mixed mesodermal tumors of the uterus) Ineligible subtypes: Alveolar rhabdomyosarcoma Kaposi's sarcoma Rhabdomyosarcoma of any type Malignant mesothelioma Chondrosarcoma Neuroblastoma Dermatofibrosarcoma Osteosarcoma Epithelioid sarcoma Primitive neuroectodermal tumor Ewing's sarcoma No extrapulmonary disease Previously treated local recurrence allowed Patients with primarily metastatic disease must have undergone radical treatment of primary tumor according to local protocols Reevaluation of metastases required before randomization PATIENT CHARACTERISTICS: Age: 16 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 1.25 times normal Renal: Creatinine no greater than 1.6 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of cardiovascular disease Other: No other severe medical illness (including psychosis) No prior or concurrent other primary malignancy except adequately treated carcinoma in situ of the cervix or basal cell carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease Prior neoadjuvant or adjuvant chemotherapy for primary soft tissue sarcoma allowed if cumulative dose of doxorubicin no greater than 200 mg/m2 At least 1 year since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, SE-22185, Sweden

Location

MeSH Terms

Conditions

Endometrial NeoplasmsKidney NeoplasmsNeoplasm MetastasisOvarian NeoplasmsPheochromocytomaSarcomaHemangiosarcomaFibrosarcomaLeiomyosarcomaLiposarcomaNeurofibrosarcomaSarcoma, SynovialHistiocytoma, Malignant FibrousHemangiopericytoma, MalignantMalignant mesenchymal tumorSarcoma, Endometrial Stromal

Interventions

FilgrastimDoxorubicinIfosfamide

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUrologic NeoplasmsKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNeoplasms, Connective and Soft TissueNeoplasms, Vascular TissueNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Muscle TissueNeoplasms, Adipose TissueNeurofibromaNerve Sheath NeoplasmsPeripheral Nervous System NeoplasmsNervous System NeoplasmsNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesHistiocytomaNeoplasms, Complex and MixedEndometrial Stromal Tumors

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • A.N. Van Geel, MD

    Daniel Den Hoed Cancer Center at Erasmus Medical Center

    STUDY CHAIR

  • Ronald H. Blum, MD

    NYU Langone Health

    STUDY CHAIR

  • Thor A. Alvegard, MD, PhD

    Lund University Hospital

    STUDY CHAIR

  • Laurence H. Baker, DO, FACOI

    University of Michigan Rogel Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 22, 2004

Study Start

April 1, 1996

Primary Completion

November 1, 2000

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

SE(1)