Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Registration Number
- NCT00075712
- Lead Sponsor
- Royal College of Obstetricians and Gynecologists
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (70)
Birmingham Women's Hospital
🇬🇧Edgbaston, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Walsgrave Hospital
🇬🇧Coventry, England, United Kingdom
Good Hope Hospital
🇬🇧West Midlands, England, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, England, United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital
🇬🇧Cheltenham, England, United Kingdom
Hammersmith Hospital
🇬🇧London, England, United Kingdom
Broomfield Hospital
🇬🇧Broomfield, England, United Kingdom
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
🇬🇧Hull, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Medical Research Council Clinical Trials Unit
🇬🇧London, England, United Kingdom
North Devon District Hospital
🇬🇧Barnstaple, England, United Kingdom
Sussex Cancer Centre at Royal Sussex County Hospital
🇬🇧Brighton, England, United Kingdom
Torbay Hospital
🇬🇧Torquay, England, United Kingdom
Barts and the London School of Medicine
🇬🇧London, England, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Royal Lancaster Infirmary
🇬🇧Lancaster, England, United Kingdom
Great Western Hospital
🇬🇧Swindon, England, United Kingdom
Taunton and Somerset Hospital
🇬🇧Taunton Somerset, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, England, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Stoke Mandeville Hospital
🇬🇧Aylesbury-Buckinghamshire, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Staffordshire General Hospital
🇬🇧Stafford, England, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
Wrexham Maelor Hospital
🇬🇧Wrexham, Wales, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, England, United Kingdom
Royal Derby Hospital
🇬🇧Derby, England, United Kingdom
St. Mary's Hospital
🇬🇧Manchester, England, United Kingdom
Royal Marsden - London
🇬🇧London, England, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, England, United Kingdom
Frimley Park Hospital
🇬🇧Frimley, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
St. Luke's Cancer Centre at Royal Surrey County Hospital
🇬🇧Guildford, England, United Kingdom
Hereford Hospitals
🇬🇧Hereford, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Liverpool Women's Hospital
🇬🇧Liverpool, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Leicester General Hospital
🇬🇧Leicester, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Milton Keynes General Hospital
🇬🇧Milton Keynes, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
Oxford Radcliffe Hospital
🇬🇧Oxford, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Whiston Hospital
🇬🇧Prescot Merseyside, England, United Kingdom
Rosemere Cancer Centre at Royal Preston Hospital
🇬🇧Preston, England, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Royal Shrewsbury Hospital
🇬🇧Shrewsbury, England, United Kingdom
Wexham Park Hospital
🇬🇧Slough, Berkshire, England, United Kingdom
University Hospital of North Staffordshire
🇬🇧Stoke-On-Trent, England, United Kingdom
St. Peter's Hospital
🇬🇧Surrey, England, United Kingdom
Walsall Manor Hospital
🇬🇧Walsall, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Centre for Cancer Research and Cell Biology at Queen's University Belfast
🇬🇧Belfast, Northern Ireland, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, England, United Kingdom