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Status unknownNCT00204568Updated Jan 8, 2013

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

A Phase 2 interventional study of Adriamycin and Trofosfamide in Sarcoma, Soft Tissue, sponsored by University Hospital Schleswig-Holstein. Status unknown at 1 site in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2013-01-08.

Sponsored by University Hospital Schleswig-Holstein · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
117
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study summary

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).

Read the 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)

02

Conditions studied

  • Sarcoma, Soft Tissue

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03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 117 is above the median of 40 across 1,283 interventional studies indexed under Sarcoma.

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Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
117 participants (estimated)

Study arms

  • Active comparator
    1

    Adriamycin mono

    Drug: Adriamycin

  • Experimental
    2

    Trofosfamide

    Drug: Trofosfamide

Interventions

  • DrugAdriamycin

    60 mg/m2, d1, W d22

  • DrugTrofosfamide

    300 mg absolute d1-7, followed by 150 mg absolute continuously

06

What researchers measure

Primary outcomes

  1. Progression-free survival after 6 months

    Progression-free survival after 6 months

    Time frame: after 6 months

Secondary outcomes

  1. 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

07

Study locations

1 site
  • University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
    Kiel, 24105, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00204568
Lead sponsor
University Hospital Schleswig-Holstein
Collaborators
Arbeitsgemeinschaft fur Internistische Onkologie, German Sarcoma Group, French Sarcoma Group
Responsible party
J. T. Hartmann (Prof. Dr. med. J. T. Hartmann, University Hospital Schleswig-Holstein) — Principal investigator
First posted
Sep 20, 2005
Start date
Aug 2004
Primary completion
Oct 2013 (estimated)
Completion
Oct 2013 (estimated)
Last update
Jan 8, 2013

Study contacts

Joerg T. Hartmann, MD
principal investigator · University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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