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Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma

Phase 2
60 Years
Open (Enrolling)
Sarcoma, Soft Tissue

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Trial Information

Randomized Phase II Trial of Trofosfamide vs. Adriamycin in Elderly Patients With Previously Untreated Metastatic Soft Tissue Sarcoma

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)

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival after 6 months

Outcome Description:

Progression-free survival after 6 months

Outcome Time Frame:

after 6 months

Safety Issue:


Principal Investigator

Joerg T. Hartmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center , Comprehensive Cancer Center North, Christian-Albrechts-University


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

August 2004

Completion Date:

October 2013

Related Keywords:

  • Sarcoma, Soft Tissue
  • Sarcoma