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RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA


Phase 3
16 Years
69 Years
Open (Enrolling)
Both
Endometrial Cancer, Kidney Cancer, Ovarian Cancer, Pheochromocytoma, Sarcoma

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Trial Information

RANDOMISED TRIAL OF ADJUVANT CHEMOTHERAPY WITH HIGH-DOSE DOXORUBICIN, IFOSFAMIDE AND LENOGRASTIM IN HIGH GRADE SOFT TISSUE SARCOMA


OBJECTIVES:

- Compare the local disease control, overall survival, and relapse-free survival in
patients with high-grade soft tissue sarcoma treated with adjuvant high-dose
doxorubicin and ifosfamide plus filgrastim (G-CSF) vs no adjuvant chemotherapy and
G-CSF after definitive surgery.

- Compare the toxicity and morbidity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, site of primary tumor (extremity vs trunk, including shoulder, pelvic girdle, head,
or neck vs central, including intrathoracic, visceral, uterine, or retroperitoneal), size of
primary tumor (less than 5 cm vs 5 cm or greater in largest diameter), postoperative
radiotherapy (yes vs no), and isolated limb perfusion therapy (yes vs no).

Some patients undergo isolated limb perfusion therapy with cytotoxics and/or cytokines.

No more than 8 weeks after biopsy or inadequate surgery, patients undergo definitive
surgery. Patients with complete resection undergo radiotherapy assessment and then
randomization. Patients with incomplete or marginal resection (except for central lesions)
undergo re-excision and, in the absence of macroscopic disease, assessment for postoperative
radiotherapy followed by randomization.

- Randomization: Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive no adjuvant chemotherapy or filgrastim (G-CSF). Beginning
within 6 weeks after surgery, eligible patients undergo radiotherapy as outlined
below.

- Arm II: Beginning within 4 weeks after surgery, patients receive high-dose
doxorubicin IV over 20 minutes followed by ifosfamide IV over 24 hours and G-CSF
subcutaneously daily beginning 24 hours after completion of ifosfamide infusion
and continuing for 10 days. Treatment continues every 3 weeks for 5 courses.
Beginning within 6 weeks after completion of chemotherapy, eligible patients
undergo radiotherapy as outlined below.

- Radiotherapy: Patients with incomplete or marginal resection undergo radiotherapy 5
days a week for 6-6.6 weeks. Patients with complete microscopic resection undergo
radiotherapy 5 days a week for 5 weeks followed by boost radiotherapy 5 days a week for
1 week.

Patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months
for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study within 3.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven soft tissue sarcoma that is amenable to definitive surgery no
more than 8 weeks after biopsy or inadequate surgery

- Eligible subtypes:

- Alveolar soft part sarcoma

- Angiosarcoma

- Fibrosarcoma

- Leiomyosarcoma

- Malignant fibrous histiocytoma

- Liposarcoma (round cell and pleomorphic)

- Miscellaneous sarcoma (including pelvic mixed mesodermal tumors)

- Malignant paraganglioma

- Neurogenic sarcoma

- Rhabdomyosarcoma

- Synovial sarcoma

- Unclassifiable sarcoma

- Ineligible subtypes:

- Chondrosarcoma

- Dermatofibrosarcoma

- Embryonal rhabdomyosarcoma

- Ewing's sarcoma

- Kaposi's sarcoma

- Liposarcoma (myxoid and well differentiated)

- Malignant mesothelioma

- Neuroblastoma

- Osteosarcoma

- Confirmed high-grade tumor (i.e., Trojani Grade II or III)

- No metastases on staging with chest x-ray and thoracic CT scan

- No regional lymph node involvement

- Locally recurrent disease allowed

- Interval of 3 months or more between definitive surgery and recurrence

PATIENT CHARACTERISTICS:

Age:

- 16 to 69

Performance status:

- WHO 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC greater than 4,000/mm^3

- Platelet count greater than 120,000/mm^3

- No bleeding disorders

Hepatic:

- Bilirubin no greater than 1.25 times normal

- No severe hepatic dysfunction

Renal:

- Creatinine less than 1.6 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No clear history of angina

- No documented myocardial infarction

- No existing cardiac failure

Other:

- No serious infection

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to affected area

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Penella J. Woll, MD, PhD

Investigator Affiliation:

Cancer Research Centre at Weston Park Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000064132

NCT ID:

NCT00002641

Start Date:

February 1995

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Kidney Cancer
  • Ovarian Cancer
  • Pheochromocytoma
  • Sarcoma
  • adult angiosarcoma
  • adult fibrosarcoma
  • adult leiomyosarcoma
  • adult liposarcoma
  • adult neurofibrosarcoma
  • adult synovial sarcoma
  • stage III adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • adult alveolar soft-part sarcoma
  • adult epithelioid sarcoma
  • adult malignant fibrous histiocytoma
  • adult malignant hemangiopericytoma
  • adult malignant mesenchymoma
  • adult rhabdomyosarcoma
  • localized benign pheochromocytoma
  • regional pheochromocytoma
  • recurrent pheochromocytoma
  • stage II uterine sarcoma
  • stage III uterine sarcoma
  • recurrent uterine sarcoma
  • uterine carcinosarcoma
  • uterine leiomyosarcoma
  • endometrial stromal sarcoma
  • ovarian sarcoma
  • clear cell sarcoma of the kidney
  • stage II adult soft tissue sarcoma
  • Endometrial Neoplasms
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Ovarian Neoplasms
  • Pheochromocytoma
  • Adenoma
  • Sarcoma

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