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A Randomized Phase III Study for the Treatment of Recurrent Epithelial Ovarian Cancer: Chemotherapy Alone Versus Chemotherapy Followed by Secondary Cytoreductive Surgery in Patients With a Treatment-Free Interval of More Than 12 Months


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

A Randomized Phase III Study for the Treatment of Recurrent Epithelial Ovarian Cancer: Chemotherapy Alone Versus Chemotherapy Followed by Secondary Cytoreductive Surgery in Patients With a Treatment-Free Interval of More Than 12 Months


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.

- Arm I: Patients undergo secondary cytoreductive surgery within 14 days of
randomization. Within 8 weeks after the last preoperative chemotherapy course, patients
continue platinum based chemotherapy every 3-4 weeks for at least 3 additional courses
in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients continue platinum based chemotherapy for at least 3 additional courses
as in arm I.

Quality of life is assessed at baseline; before the 4th or 6th course of chemotherapy or 1
week before surgery; after the 6th course of chemotherapy in the chemotherapy only arm OR
before the 4th or 6th course of chemotherapy in the surgery arm; 2 months after chemotherapy
or after the 6th course of chemotherapy in the surgery arm; and then every 6 months for up
to 5 years.

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.

Inclusion 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:

- No peripheral neurotoxicity greater than grade 2

- No psychological, familial, sociological, or geographical condition that would
preclude study

- No complete bowel obstruction

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Giuseppe Favalli, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ospedale Sta. Maria Delle Croci

Authority:

United States: Federal Government

Study ID:

EORTC-55963

NCT ID:

NCT00006356

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms

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