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Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer - Article


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Plastic and Cosmetic Surgery

Cosmetic Surgery; Surgery, Plastic


Clinical Trial: Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer

This study is no longer recruiting patients.

Sponsored by: EORTC Gynecological Cancer Cooperative Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy with or without surgery in treating patients who have recurrent epithelial ovarian cancer.

Condition Treatment or Intervention Phase
recurrent ovarian epithelial cancer
 Drug: carboplatin
 Drug: cisplatin
 Procedure: chemotherapy
 Procedure: conventional surgery
 Procedure: surgery
Phase III

MedlinePlus related topics:  Ovarian Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Chemotherapy With or Without Secondary Cytoreductive Surgery in Patients With Recurrent Ovarian Epithelial Cancer

Further Study Details: 

OBJECTIVES:

  • Compare survival and progression free survival in patients with ovarian epithelial cancer after receiving treatment with chemotherapy with or without secondary cytoreductive surgery.
  • Determine the toxicity of these treatment regimens in these patients.
  • Determine the complications related to surgical treatment in these patients.
  • Compare the quality of life in these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage at initial diagnosis (early stage I-IIa vs advanced stage IIb-IV), length of interval from end of prior first line chemotherapy (1-2 years vs more than 2 years), response to first 3 courses of second line induction chemotherapy in this study (no change vs partial remission vs complete remission), number of measurable tumor lesions (1 vs more than 1), largest tumor size of recurrence (less than 5 cm vs 5 cm or more), and participating center.

Patients receive second line induction chemotherapy with either 3 courses of a 3-4 week regimen or 6 courses of a weekly regimen of platinum based (cisplatin or carboplatin) therapy. Patients with no change, partial remission, or complete remission are randomized to one of two treatment arms.

Patients are followed every 3 months for 2 years, and then every 6 months for 3 years or until disease progression.

PROJECTED ACCRUAL: Approximately 700 patients will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed recurrent ovarian epithelial cancer after first line chemotherapy, unless clear evidence of clinically progressive disease
  • Must have received prior first line chemotherapy consisting of at least 4 courses of either cisplatin or carboplatin
  • At least 12 months since prior chemotherapy
  • Measurable disease by clinical exam or diagnostic laparoscopy
  • At least one lesion greater than 1 cm in diameter
  • No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS: Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.25 times upper limit of normal (ULN)
  • SGPT less than 2 times ULN

Renal:

  • Creatinine less than 1.6 mg/dL OR
  • Creatinine clearance greater than 40 mL/min

Other:

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • Not specified

Chemotherapy:

  • No more than 1 prior regimen of chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Location Information


Italy
      Spedali Civili, Brescia,  25123,  Italy

Study chairs or principal investigators

Giuseppe Favalli, MD,  Study Chair,  Spedali Civili   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068224; EORTC-55963
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  October 4, 2000
ClinicalTrials.gov Identifier:  NCT00006356
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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September 7, 2008



Page Updated: October 3, 2005
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