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

August 9, 2013 updated by: Royal College of Obstetricians and Gynecologists

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Aylesbury-Buckinghamshire, England, United Kingdom, HP21 8AL
        • Stoke Mandeville Hospital
      • Barnstaple, England, United Kingdom, EX31 4JB
        • North Devon District Hospital
      • Bath, England, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Blackpool, England, United Kingdom, FY3 8NR
        • Blackpool Victoria Hospital
      • Bradford, England, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Brighton, England, United Kingdom, BN2 5BE
        • Sussex Cancer Centre at Royal Sussex County Hospital
      • Broomfield, England, United Kingdom, CM1 7ET
        • Broomfield Hospital
      • Carlisle, England, United Kingdom, CA2 7HY
        • Cumberland Infirmary
      • Cheltenham, England, United Kingdom, GL53 7AN
        • Gloucestershire Oncology Centre at Cheltenham General Hospital
      • Colchester, England, United Kingdom, C03 3NB
        • Essex County Hospital
      • Coventry, England, United Kingdom, CV2 2DX
        • Walsgrave Hospital
      • Derby, England, United Kingdom, DE1 2QY
        • Derbyshire Royal Infirmary
      • Derby, England, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Edgbaston, England, United Kingdom, B15 2TG
        • Birmingham Women's Hospital
      • Exeter, England, United Kingdom, EX2 5DW
        • Royal Devon and Exeter Hospital
      • Frimley, England, United Kingdom, GU16 5UJ
        • Frimley Park Hospital
      • Gateshead, England, United Kingdom, NE9 6SX
        • Queen Elizabeth Hospital
      • Guildford, England, United Kingdom, GU2 7XX
        • St. Luke's Cancer Centre at Royal Surrey County Hospital
      • Hereford, England, United Kingdom, HR1 2ER
        • Hereford Hospitals
      • Hull, England, United Kingdom, HU8 9HE
        • Princess Royal Hospital at Hull and East Yorkshire NHS Trust
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Lancaster, England, United Kingdom, LA1 4RP
        • Royal Lancaster Infirmary
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Leicester, England, United Kingdom, LE5 4PW
        • Leicester General Hospital
      • Lincoln, England, United Kingdom, LN2 5QY
        • Lincoln County Hospital
      • Liverpool, England, United Kingdom, L8 7SS
        • Liverpool Women's Hospital
      • London, England, United Kingdom, SW17 0QT
        • St. George's Hospital
      • London, England, United Kingdom, EC1A 7BE
        • Saint Bartholomew's Hospital
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden - London
      • London, England, United Kingdom, W12 OHS
        • Hammersmith Hospital
      • London, England, United Kingdom, NW1 2DA
        • Medical Research Council Clinical Trials Unit
      • London, England, United Kingdom, EC1M 6GR
        • Barts and the London School of Medicine
      • Manchester, England, United Kingdom, M23 9LJ
        • Wythenshawe Hospital
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Manchester, England, United Kingdom, M13 0JH
        • St. Mary's Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • Middlesbrough, England, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Milton Keynes, England, United Kingdom, MK6 5LD
        • Milton Keynes General Hospital
      • Northampton, England, United Kingdom, NN1 5BD
        • Northampton General Hospital
      • Norwich, England, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
      • Oxford, England, United Kingdom, 0X3 7LJ
        • Oxford Radcliffe Hospital
      • Plymouth, England, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Poole Dorset, England, United Kingdom, BH15 2JB
        • Dorset Cancer Centre
      • Portsmouth Hants, England, United Kingdom, PO3 6AD
        • Portsmouth Oncology Centre at Saint Mary's Hospital
      • Prescot Merseyside, England, United Kingdom, L35 5DR
        • Whiston Hospital
      • Preston, England, United Kingdom, PR2 9HT
        • Rosemere Cancer Centre at Royal Preston Hospital
      • Romford, England, United Kingdom, RM7 OBE
        • Oldchurch Hospital
      • Sheffield, England, United Kingdom, S1O 2JF
        • Royal Hallamshire Hospital
      • Sheffield, England, United Kingdom, S10 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Shrewsbury, England, United Kingdom, SY3 8XQ
        • Royal Shrewsbury Hospital
      • Slough, Berkshire, England, United Kingdom, SL2 4HL
        • Wexham Park Hospital
      • Stafford, England, United Kingdom, ST16 3SA
        • Staffordshire General Hospital
      • Stoke-On-Trent, England, United Kingdom, ST4 7LN
        • University Hospital of North Staffordshire
      • Surrey, England, United Kingdom, KT 16 OPZ
        • St. Peter's Hospital
      • Swindon, England, United Kingdom, SN3 6BB
        • Great Western Hospital
      • Taunton Somerset, England, United Kingdom, TA1 5DA
        • Taunton and Somerset Hospital
      • Torquay, England, United Kingdom, TQ2 7AA
        • Torbay Hospital
      • Walsall, England, United Kingdom, WS2 9PS
        • Walsall Manor Hospital
      • West Midlands, England, United Kingdom, B75 7RR
        • Good Hope Hospital
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
      • Yeovil, England, United Kingdom, BA21 4AT
        • Yeovil District Hospital
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT9 7BL
        • Centre for Cancer Research and Cell Biology at Queen's University Belfast
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Inverness, Scotland, United Kingdom, 1V2 3UJ
        • Raigmore Hospital
    • Wales
      • Bangor, Wales, United Kingdom, LL57 2PW
        • Ysbyty Gwynedd
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • University Hospital of Wales
      • Cardiff, Wales, United Kingdom, CF4 7XL
        • Velindre Cancer Center at Velindre Hospital
      • Swansea, Wales, United Kingdom, SA2 8QA
        • South West Wales Cancer Institute
      • Wrexham, Wales, United Kingdom, LL13 7TD
        • Wrexham Maelor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Obstetricians and Gynecologists

Investigators

  • Principal Investigator: Sean Kehoe, Oxford University Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 12, 2004

First Posted (Estimate)

January 13, 2004

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCOG-MRC-CHORUS
  • CDR0000347463 (Registry Identifier: PDQ (Physician Data Query))
  • EU-20350
  • ISRCTN74802813

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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