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



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

For Condition: peritoneal cavity cancer,stage 4 ovarian epithelial cancer,stage 3 ovarian epithelial cancer,Fallopian Tube Cancer
Status: Recruiting
Sponsor(s): Royal College of Obstetricians and Gynecologists ,
Synopsis: 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 primaryperitoneal cavity cancer. PURPOSE: Randomizedphase II/III trial to compare the effectiveness of giving chemotherapy before and after surgery with that of giving chemotherapy after surgery in treating patients who have newly diagnosed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SeanKehoe,  Principal Investigator,  Oxford Radcliffe Hospital

Oxford Radcliffe Hospital *Recruiting*
Oxford,  England,  0X3 7LJ
United Kingdom
Recruiting Sean  Kehoe 44-1865-741-166

Christie Hospital N.H.S. Trust *Recruiting*
Manchester,  England,  M20 4BX
United Kingdom
Recruiting Gordon  Jayson 44-161-446-3606

Medical Research Council Clinical Trials Unit *Recruiting*
London,  England,  NW1 2DA
United Kingdom
Recruiting Sarah  Wheeler 44-207-7670-4759


Additional Information:
Study ID Numbers:
  CDR0000347463;  RCOG-MRC-CHORUS,EU-20350
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075712

Other Peritoneal Cavity Cancer Studies:
1. Melphalan and Thiotepa Followed by Peripheral Stem Cell Transplantation in Treating Patients With Epithelial Ovarian Cancer in Complete Remission

2. Radiolabeled Monoclonal Antibody in Treating Patients With Advanced Ovarian Epithelial Cancer

3. Genetic Study in Patients with Advanced Epithelial Ovarian Cancer

4. Carboplatin and Paclitaxel With or Without Gemcitabine in Treating Patients With Ovarian Epithelial or Fallopian Tube Cancer

5. Carboplatin With or Without Liposomal Doxorubicin in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

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