NCT00075712

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

70 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2004

Completed
Last Updated

August 12, 2013

Status Verified

May 1, 2007

First QC Date

January 9, 2004

Last Update Submit

August 9, 2013

Conditions

Keywords

stage IV ovarian epithelial cancerstage IIIA fallopian tube cancerstage IIIB fallopian tube cancerstage IIIC fallopian tube cancerstage IV fallopian tube cancerstage IIIA primary peritoneal cavity cancerstage IIIB primary peritoneal cavity cancerstage IIIC primary peritoneal cavity cancerstage IV primary peritoneal cavity cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancer

Outcome Measures

Primary Outcomes (3)

  • 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)

Interventions

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (70)

Stoke Mandeville Hospital

Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom

Location

North Devon District Hospital

Barnstaple, England, EX31 4JB, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Blackpool Victoria Hospital

Blackpool, England, FY3 8NR, United Kingdom

Location

Bradford Royal Infirmary

Bradford, England, BD9 6RJ, United Kingdom

Location

Sussex Cancer Centre at Royal Sussex County Hospital

Brighton, England, BN2 5BE, United Kingdom

Location

Broomfield Hospital

Broomfield, England, CM1 7ET, United Kingdom

Location

Cumberland Infirmary

Carlisle, England, CA2 7HY, United Kingdom

Location

Gloucestershire Oncology Centre at Cheltenham General Hospital

Cheltenham, England, GL53 7AN, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Walsgrave Hospital

Coventry, England, CV2 2DX, United Kingdom

Location

Derbyshire Royal Infirmary

Derby, England, DE1 2QY, United Kingdom

Location

Royal Derby Hospital

Derby, England, DE22 3NE, United Kingdom

Location

Birmingham Women's Hospital

Edgbaston, England, B15 2TG, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Frimley Park Hospital

Frimley, England, GU16 5UJ, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

St. Luke's Cancer Centre at Royal Surrey County Hospital

Guildford, England, GU2 7XX, United Kingdom

Location

Hereford Hospitals

Hereford, England, HR1 2ER, United Kingdom

Location

Princess Royal Hospital at Hull and East Yorkshire NHS Trust

Hull, England, HU8 9HE, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Royal Lancaster Infirmary

Lancaster, England, LA1 4RP, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Leicester General Hospital

Leicester, England, LE5 4PW, United Kingdom

Location

Lincoln County Hospital

Lincoln, England, LN2 5QY, United Kingdom

Location

Liverpool Women's Hospital

Liverpool, England, L8 7SS, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Barts and the London School of Medicine

London, England, EC1M 6GR, United Kingdom

Location

Medical Research Council Clinical Trials Unit

London, England, NW1 2DA, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

St. Mary's Hospital

Manchester, England, M13 0JH, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Wythenshawe Hospital

Manchester, England, M23 9LJ, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Milton Keynes General Hospital

Milton Keynes, England, MK6 5LD, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Oxford Radcliffe Hospital

Oxford, England, 0X3 7LJ, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Whiston Hospital

Prescot Merseyside, England, L35 5DR, United Kingdom

Location

Rosemere Cancer Centre at Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S10 2SJ, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, England, S1O 2JF, United Kingdom

Location

Royal Shrewsbury Hospital

Shrewsbury, England, SY3 8XQ, United Kingdom

Location

Wexham Park Hospital

Slough, Berkshire, England, SL2 4HL, United Kingdom

Location

Staffordshire General Hospital

Stafford, England, ST16 3SA, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, England, ST4 7LN, United Kingdom

Location

St. Peter's Hospital

Surrey, England, KT 16 OPZ, United Kingdom

Location

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Taunton and Somerset Hospital

Taunton Somerset, England, TA1 5DA, United Kingdom

Location

Torbay Hospital

Torquay, England, TQ2 7AA, United Kingdom

Location

Walsall Manor Hospital

Walsall, England, WS2 9PS, United Kingdom

Location

Good Hope Hospital

West Midlands, England, B75 7RR, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Yeovil District Hospital

Yeovil, England, BA21 4AT, United Kingdom

Location

Centre for Cancer Research and Cell Biology at Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF4 7XL, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, Wales, LL13 7TD, United Kingdom

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CarboplatinPaclitaxelChemotherapy, AdjuvantNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenesCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Sean Kehoe

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 13, 2004

Study Start

September 1, 2003

Last Updated

August 12, 2013

Record last verified: 2007-05

Locations