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Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
French Sarcoma Group
Information provided by (Responsible Party):
J. T. Hartmann, University of Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00204568
First received: September 13, 2005
Last updated: January 7, 2013
Last verified: January 2013
History of Changes

September 13, 2005
January 7, 2013
August 2004
October 2013   (final data collection date for primary outcome measure)
Progression-free survival after 6 months [ Time Frame: after 6 months ] [ Designated as safety issue: Yes ]
Progression-free survival after 6 months
Not Provided
Complete list of historical versions of study NCT00204568 on ClinicalTrials.gov Archive Site
Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30 [ Designated as safety issue: Yes ]
Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival Quality of life according to EORTC QLQ-30
Not Provided
Not Provided
Not Provided
 
Trofosfamide Versus Adriamycin in Elderly Patients With Soft Tissue Sarcoma (STS)
Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma

The goal of this trial is to determine whether oral continuous (metronomic) therapy with trofosfamide results in a similar rate of progression-free time after 6 months as intravenous treatment with adriamycin. In addition, the study is intended to investigate the level of toxicity associated with the two treatment regimens (safety profile).

Group A:Adriamycin (60 mg/m2, d1, qd22) 75 mg/m2 may be applied instead of 60 mg/m2 for patients between 60 and 70 years of age (optional) Group B:Trofosfamide (300 mg absolute p.o. qd over 7 days, then 150 mg p.o. absolute qd continuously) In case of absence of any toxicity during treatment with trofosfamide 150 mg absolute a dose escalation to 200 mg absolute is allowed (optional)
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sarcoma, Soft Tissue
  • Drug: Adriamycin
    60 mg/m2, d1, W d22
  • Drug: Trofosfamide
    300 mg absolute d1-7, followed by 150 mg absolute continuously
  • Active Comparator: 1
    Adriamycin mono
    Intervention: Drug: Adriamycin
  • Experimental: 2
    Trofosfamide
    Intervention: Drug: Trofosfamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
117
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically established metastatic (N+ or M1 = stage IV) or non-resectable soft tissue sarcoma·
  • Grading II/III (Guillou et al. J Clin Oncol 1997)
  • At least 1 measurable tumor parameter according to RECIST criteria
  • Evidence of progression or primary manifestation (except osseous metastases and pleural effusion)
  • No previous radiation therapy of the only measurable lesion
  • No previous chemotherapy for metastatic disease; previous adjuvant chemotherapy is permitted if there was no progression of the disease within a period of 6 months
  • Patients aged 60 years and beyond
  • Written patient informed consent
  • ECOG Status 0-2
  • Granulocytes >= 2 x 10**9/l and thrombocytes >= 100 x 10**/l
  • Serum creatinine, bilirubin < 1.5 times the upper limit of normal value, albumin > 25 g/l
  • No severe comorbidity including psychosis or any previous history of uncontrolled cardiovascular disease
  • Normal left-ventricular function by echocardiography or MUGA scan
  • No symptomatic CNS metastases
  • Willingness to receive regular follow-up examinations

Exclusion Criteria:

  • Histological grading of malignancy: G I
  • Histology of gastrointestinal stromal tumor, chondrosarcoma, uterine stromal sarcoma, mesothelioma, neuroblastoma, osteosarcoma, Ewing´s sarcoma/PNET, desmoplastic round cell tumor, embryonal rhabdomyosarcoma, alveolar soft tissue sarcoma
  • Less than 5 years free of secondary malignancy except adequately treated carcinoma in situ (CIS) of the cervix, the bladder urothelium, basal cell carcinoma, or adenoma of the colon including pTIS, pTIN
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00204568
jth_001
Not Provided
J. T. Hartmann, University of Schleswig-Holstein
University of Schleswig-Holstein
  • Arbeitsgemeinschaft fur Internistische Onkologie
  • German Sarcoma Group
  • French Sarcoma Group
Principal Investigator: Joerg T. Hartmann, MD University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
University of Schleswig-Holstein
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP