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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by J. T. Hartmann, University of Schleswig-Holstein.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00204568
First Posted: September 20, 2005
Last Update Posted: January 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
French Sarcoma Group
Information provided by (Responsible Party):
J. T. Hartmann, University of Schleswig-Holstein
  Purpose
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).

Condition Intervention Phase
Sarcoma, Soft Tissue Drug: Adriamycin Drug: Trofosfamide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma

Resource links provided by NLM:


Further study details as provided by J. T. Hartmann, University of Schleswig-Holstein:

Primary Outcome Measures:
  • Progression-free survival after 6 months [ Time Frame: after 6 months ]
    Progression-free survival after 6 months


Secondary Outcome Measures:
  • Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival • Quality of life according to EORTC QLQ-30
    Grade III/IV toxicity Objective remission rate according to RECIST criteria Overall survival Quality of life according to EORTC QLQ-30


Estimated Enrollment: 117
Study Start Date: August 2004
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Adriamycin mono
Drug: Adriamycin
60 mg/m2, d1, W d22
Experimental: 2
Trofosfamide
Drug: Trofosfamide
300 mg absolute d1-7, followed by 150 mg absolute continuously

Detailed Description:
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204568


Locations
Germany
University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
Kiel, Germany, 24105
Sponsors and Collaborators
University of Schleswig-Holstein
Arbeitsgemeinschaft fur Internistische Onkologie
German Sarcoma Group
French Sarcoma Group
Investigators
Principal Investigator: Joerg T. Hartmann, MD University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
  More Information

Responsible Party: J. T. Hartmann, Prof. Dr. med. J. T. Hartmann, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00204568     History of Changes
Other Study ID Numbers: jth_001
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: January 8, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Trofosfamide
Cyclophosphamide
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Antirheumatic Agents
Myeloablative Agonists