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Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Neoplasms by Histologic Type

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Soft Tissue Sarcoma

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Antineoplastic Agents

All Drugs and Chemicals

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Doxorubicin

Liposomal doxorubicin

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Antibiotics, Antitubercular

Enzyme Inhibitors

Antineoplastic Agents, Alkylating

Alkylating Agents

filgrastim

doxorubicin hydrochloride

ifosfamide

conventional surgery

A.N. Van Geel, MD

Ronald H. Blum, MD

Thor A. Alvegard, MD, PhD

Laurence H. Baker, DO, FACOI

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery plus combination chemotherapy is more effective than surgery alone in treating patients with lung metastases from soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery plus combination chemotherapy with that of surgery alone in treating patients who have soft tissue sarcoma that has spread to the lung.

OBJECTIVES: I. Compare disease control, overall survival, and relapse-free survival in patients with lung metastases secondary to soft tissue sarcoma treated with high-dose doxorubicin and ifosfamide with or without filgrastim (G-CSF) before and after metastasectomy vs metastasectomy alone. II. Determine the safety and morbidity of this regimen in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to location of metastases (unilateral vs bilateral). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients are assigned to regimen A or B. Regimen A: Patients receive high-dose doxorubicin IV and ifosfamide IV continuously on day 1 and filgrastim (G-CSF) subcutaneously on days 3-13. Regimen B: Patients receive chemotherapy as above without G-CSF. Treatment on both regimens continues every 3 weeks for 3 courses. Patients then undergo radical pulmonary metastasectomy via thoracotomy or sternotomy with wedge resection or lobectomy. Patients with responding disease after metastasectomy receive 2 additional courses on the regimen to which they were originally assigned. Arm II: Patients undergo radical pulmonary metastasectomy as in arm I. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 340 patients (170 per treatment arm) will be accrued for this study within approximately 4.5 years.

Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma

METASTASECTOMY AND CHEMOTHERAPY FOR LUNG METASTASES FROM SOFT TISSUE SARCOMA: A RANDOMIZED PHASE III STUDY (AN INTERGROUP STUDY WITH THE SCANDINAVIAN SARCOMA GROUP)

Eastern Cooperative Oncology Group

Scandinavian Sarcoma Group

SWOG Cancer Research Network

European Organisation for Research and Treatment of Cancer - EORTC

Carcinosarcoma

Mixed Tumor, Mullerian

Rhabdomyosarcoma

Sarcoma, Alveolar Soft Part

Malignant Mixed Mullerian Tumor

Epithelioid Sarcoma

Alveolar Soft Part Sarcoma

Uterine Carcinosarcoma

isolated perfusion

adjuvant therapy

radiation therapy

Penella J. Woll, MD, PhD

Vivien H.C. Bramwell, MB, BS, PhD, FRCP

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether giving chemotherapy after surgery is more effective than surgery alone in treating soft tissue sarcoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without chemotherapy in treating patients who have 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.

Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma

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

NCIC Clinical Trials Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma	NCT00002764	Endometrial Can... Kidney Cancer Metastatic Canc... Ovarian Cancer Pheochromocytom... Sarcoma	filgrastim doxorubicin hyd... ifosfamide conventional su...	16 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma	NCT00002641	Endometrial Can... Kidney Cancer Ovarian Cancer Pheochromocytom... Sarcoma	filgrastim doxorubicin hyd... ifosfamide isolated perfus... adjuvant therap... conventional su... radiation thera...	16 Years - 69 Years	European Organisation for Research and Treatment of Cancer - EORTC
Surgery With or Without Combination Chemotherapy in Treating Patients With Lung Metastases From Soft Tissue Sarcoma	NCT00002764	Endometrial Can... Kidney Cancer Metastatic Canc... Ovarian Cancer Pheochromocytom... Sarcoma	filgrastim doxorubicin hyd... ifosfamide conventional su...	16 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for localized benign pheochromocytoma