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Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma

Phase 3
18 Years
60 Years
Open (Enrolling)

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Trial Information

Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma


- Compare the progression-free and overall survival of patients with locally advanced or
metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and
pegfilgrastim as first-line therapy.

- Compare the response in patients treated with these regimens.

- Compare the treatment-related mortality of patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50
years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs
3), and participating center. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).

- Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on
days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression and then every 12 weeks

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

Inclusion Criteria


- Histologically confirmed soft tissue sarcoma

- Locally advanced unresectable* OR metastatic disease

- High-grade (grade 2-3) disease according to the FNLCC grading system NOTE:
*Disease that could prove resectable (including pulmonary metastasectomy) after
a response to chemotherapy is allowed

- The following tumor types are eligible:

- Malignant fibrous histiocytoma

- Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated

- Pleomorphic rhabdomyosarcoma

- Synovial sarcoma

- Myxofibrosarcoma, intermediate and high-grade

- Fibrosarcoma

- Leiomyosarcoma

- Angiosarcoma

- Malignant peripheral nerve sheath tumor

- Epithelioid sarcoma

- Alveolar rhabdomyosarcoma

- Unclassifiable sarcoma, not otherwise specified

- The following tumor types are not eligible:

- Gastrointestinal stromal tumor

- Mixed mesodermal tumor

- Chondrosarcoma

- Malignant mesothelioma

- Neuroblastoma

- Osteosarcoma

- Ewing's sarcoma/primitive neuroectodermal tumor

- Desmoplastic small round cell tumor

- Embryonal rhabdomyosarcoma

- Alveolar soft part sarcoma

- Must have a measurable lesion with clinical evidence of progression within the past 6

- Osseous lesions and pleural effusions are not considered measurable

- No known or symptomatic CNS metastases



- 18 to 60

Performance status

- WHO 0-1

Life expectancy

- Not specified


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.8 mg/dL

- Albumin at least 2.5 g/dL


- Creatinine no greater than 1.4 mg/dL OR

- Creatinine clearance greater than 65 mL/min


- No history of cardiovascular disease


- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other severe medical illness

- No psychosis

- No other prior or concurrent malignancy except adequately treated carcinoma in situ
of the cervix or basal cell skin cancer

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance and follow-up schedule


Biologic therapy

- Not specified


- No prior chemotherapy for advanced or metastatic disease

- Prior adjuvant chemotherapy allowed provided there was no disease progression within
6 months after completion of treatment

Endocrine therapy

- Not specified


- No prior radiotherapy to the sole index lesion


- Not specified

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Ian R. Judson, MA, MD, FRCP

Investigator Affiliation:

Institute of Cancer Research, United Kingdom


United States: Federal Government

Study ID:




Start Date:

April 2003

Completion Date:

Related Keywords:

  • Sarcoma
  • adult angiosarcoma
  • adult epithelioid sarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult rhabdomyosarcoma
  • adult synovial sarcoma
  • stage III adult soft tissue sarcoma
  • adult malignant fibrous histiocytoma
  • adult neurofibrosarcoma
  • stage II adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Sarcoma