Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy work in 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; giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before and after surgery works and compares it to giving chemotherapy after surgery alone in treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

Detailed Description
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OBJECTIVES: Determine the feasibility of a randomized trial to determine the impact of the timing of surgery and chemotherapy in patients with newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer. OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I (primary surgery): Patients undergo radical surgery. Within 6 weeks after primary surgery, patients receive chemotherapy comprising carboplatin alone or in combination with paclitaxel or another chemotherapy agent on day 1. Chemotherapy repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo interval debulking surgery after the third course of chemotherapy. Arm II (neoadjuvant chemotherapy): Patients receive chemotherapy as in arm I for 3 courses. Within 3 weeks after chemotherapy, patients undergo radical surgery. Within 6 weeks after surgery, patients receive an additional 3 courses of chemotherapy as in arm I. Patients are followed at 9 months after randomization, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 100-150 patients will be accrued for this study within 18 months.

Official Title
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A Randomized Feasibility Trial to Determine the Impact of Timing of Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma

Conditions
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Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel
* Procedure: adjuvant therapy
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer Clinical and imaging evidence of a pelvic mass with extrapelvic metastases within the past 4 weeks Serum CA 125/CEA ratio > 25 Plans to receive carboplatin-based chemotherapy PATIENT CHARACTERISTICS: Age Adult Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Considered fit to undergo protocol treatment and follow-up No other prior or concurrent malignancy that would preclude study treatment or comparisons PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: paclitaxel|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 3 years |  |  | 
| Progression-free survival |  |  | 
| Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV ovarian epithelial cancer, stage IIIA fallopian tube cancer, stage IIIB fallopian tube cancer, stage IIIC fallopian tube cancer, stage IV fallopian tube cancer, stage IIIA primary peritoneal cavity cancer, stage IIIB primary peritoneal cavity cancer, stage IIIC primary peritoneal cavity cancer, stage IV primary peritoneal cavity cancer, stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer