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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

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
carboplatin
paclitaxel
adjuvant therapy
conventional surgery
neoadjuvant therapy
Sponsored by
Royal College of Obstetricians and Gynecologists
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Stoke Mandeville Hospital
  • North Devon District Hospital
  • Royal United Hospital
  • Blackpool Victoria Hospital
  • Bradford Royal Infirmary
  • Sussex Cancer Centre at Royal Sussex County Hospital
  • Broomfield Hospital
  • Cumberland Infirmary
  • Gloucestershire Oncology Centre at Cheltenham General Hospital
  • Essex County Hospital
  • Walsgrave Hospital
  • Derbyshire Royal Infirmary
  • Royal Derby Hospital
  • Birmingham Women's Hospital
  • Royal Devon and Exeter Hospital
  • Frimley Park Hospital
  • Queen Elizabeth Hospital
  • St. Luke's Cancer Centre at Royal Surrey County Hospital
  • Hereford Hospitals
  • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
  • Ipswich Hospital
  • Royal Lancaster Infirmary
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester General Hospital
  • Lincoln County Hospital
  • Liverpool Women's Hospital
  • Saint Bartholomew's Hospital
  • Barts and the London School of Medicine
  • Medical Research Council Clinical Trials Unit
  • St. George's Hospital
  • Royal Marsden - London
  • Hammersmith Hospital
  • St. Mary's Hospital
  • Christie Hospital
  • Wythenshawe Hospital
  • Clatterbridge Centre for Oncology
  • James Cook University Hospital
  • Milton Keynes General Hospital
  • Northampton General Hospital
  • Norfolk and Norwich University Hospital
  • Oxford Radcliffe Hospital
  • Derriford Hospital
  • Dorset Cancer Centre
  • Portsmouth Oncology Centre at Saint Mary's Hospital
  • Whiston Hospital
  • Rosemere Cancer Centre at Royal Preston Hospital
  • Oldchurch Hospital
  • Cancer Research Centre at Weston Park Hospital
  • Royal Hallamshire Hospital
  • Royal Shrewsbury Hospital
  • Wexham Park Hospital
  • Staffordshire General Hospital
  • University Hospital of North Staffordshire
  • St. Peter's Hospital
  • Great Western Hospital
  • Taunton and Somerset Hospital
  • Torbay Hospital
  • Walsall Manor Hospital
  • Good Hope Hospital
  • Southend University Hospital NHS Foundation Trust
  • Yeovil District Hospital
  • Centre for Cancer Research and Cell Biology at Queen's University Belfast
  • Aberdeen Royal Infirmary
  • Ninewells Hospital
  • Raigmore Hospital
  • Ysbyty Gwynedd
  • University Hospital of Wales
  • Velindre Cancer Center at Velindre Hospital
  • South West Wales Cancer Institute
  • Wrexham Maelor Hospital

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
January 9, 2004
Last Updated
August 9, 2013
Sponsor
Royal College of Obstetricians and Gynecologists
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1. Study Identification

Unique Protocol Identification Number
NCT00075712
Brief Title
Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal College of Obstetricians and Gynecologists

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Overall survival at 3 years
Title
Progression-free survival
Title
Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Kehoe
Organizational Affiliation
Oxford University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stoke Mandeville Hospital
City
Aylesbury-Buckinghamshire
State/Province
England
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
North Devon District Hospital
City
Barnstaple
State/Province
England
ZIP/Postal Code
EX31 4JB
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
England
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
State/Province
England
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Sussex Cancer Centre at Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Broomfield Hospital
City
Broomfield
State/Province
England
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Facility Name
Cumberland Infirmary
City
Carlisle
State/Province
England
ZIP/Postal Code
CA2 7HY
Country
United Kingdom
Facility Name
Gloucestershire Oncology Centre at Cheltenham General Hospital
City
Cheltenham
State/Province
England
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Walsgrave Hospital
City
Coventry
State/Province
England
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Derbyshire Royal Infirmary
City
Derby
State/Province
England
ZIP/Postal Code
DE1 2QY
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
State/Province
England
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
Birmingham Women's Hospital
City
Edgbaston
State/Province
England
ZIP/Postal Code
B15 2TG
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Frimley Park Hospital
City
Frimley
State/Province
England
ZIP/Postal Code
GU16 5UJ
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Hereford Hospitals
City
Hereford
State/Province
England
ZIP/Postal Code
HR1 2ER
Country
United Kingdom
Facility Name
Princess Royal Hospital at Hull and East Yorkshire NHS Trust
City
Hull
State/Province
England
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Royal Lancaster Infirmary
City
Lancaster
State/Province
England
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester General Hospital
City
Leicester
State/Province
England
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Lincoln County Hospital
City
Lincoln
State/Province
England
ZIP/Postal Code
LN2 5QY
Country
United Kingdom
Facility Name
Liverpool Women's Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L8 7SS
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Barts and the London School of Medicine
City
London
State/Province
England
ZIP/Postal Code
EC1M 6GR
Country
United Kingdom
Facility Name
Medical Research Council Clinical Trials Unit
City
London
State/Province
England
ZIP/Postal Code
NW1 2DA
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Marsden - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
State/Province
England
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M13 0JH
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Wythenshawe Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9LJ
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
State/Province
England
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Milton Keynes General Hospital
City
Milton Keynes
State/Province
England
ZIP/Postal Code
MK6 5LD
Country
United Kingdom
Facility Name
Northampton General Hospital
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 7LJ
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
State/Province
England
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Dorset Cancer Centre
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Portsmouth Oncology Centre at Saint Mary's Hospital
City
Portsmouth Hants
State/Province
England
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Whiston Hospital
City
Prescot Merseyside
State/Province
England
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Rosemere Cancer Centre at Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2JF
Country
United Kingdom
Facility Name
Royal Shrewsbury Hospital
City
Shrewsbury
State/Province
England
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Wexham Park Hospital
City
Slough, Berkshire
State/Province
England
ZIP/Postal Code
SL2 4HL
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
State/Province
England
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Stoke-On-Trent
State/Province
England
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
St. Peter's Hospital
City
Surrey
State/Province
England
ZIP/Postal Code
KT 16 OPZ
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
State/Province
England
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Taunton and Somerset Hospital
City
Taunton Somerset
State/Province
England
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
Walsall Manor Hospital
City
Walsall
State/Province
England
ZIP/Postal Code
WS2 9PS
Country
United Kingdom
Facility Name
Good Hope Hospital
City
West Midlands
State/Province
England
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Centre for Cancer Research and Cell Biology at Queen's University Belfast
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7BL
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF4 7XL
Country
United Kingdom
Facility Name
South West Wales Cancer Institute
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Wrexham Maelor Hospital
City
Wrexham
State/Province
Wales
ZIP/Postal Code
LL13 7TD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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