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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000347463 | Registry Identifier | PDQ (Physician Data Query) | |
| EU-20350 | |||
| ISRCTN74802813 |
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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.
OBJECTIVES:
OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug | |||
| paclitaxel | Drug | |||
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Sean Kehoe | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stoke Mandeville Hospital | Aylesbury-Buckinghamshire | England | HP21 8AL | United Kingdom | ||
| North Devon District Hospital |
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| Barnstaple |
| England |
| EX31 4JB |
| United Kingdom |
| Royal United Hospital | Bath | England | BA1 3NG | United Kingdom |
| Blackpool Victoria Hospital | Blackpool | England | FY3 8NR | United Kingdom |
| Bradford Royal Infirmary | Bradford | England | BD9 6RJ | United Kingdom |
| Sussex Cancer Centre at Royal Sussex County Hospital | Brighton | England | BN2 5BE | United Kingdom |
| Broomfield Hospital | Broomfield | England | CM1 7ET | United Kingdom |
| Cumberland Infirmary | Carlisle | England | CA2 7HY | United Kingdom |
| Gloucestershire Oncology Centre at Cheltenham General Hospital | Cheltenham | England | GL53 7AN | United Kingdom |
| Essex County Hospital | Colchester | England | C03 3NB | United Kingdom |
| Walsgrave Hospital | Coventry | England | CV2 2DX | United Kingdom |
| Derbyshire Royal Infirmary | Derby | England | DE1 2QY | United Kingdom |
| Royal Derby Hospital | Derby | England | DE22 3NE | United Kingdom |
| Birmingham Women's Hospital | Edgbaston | England | B15 2TG | United Kingdom |
| Royal Devon and Exeter Hospital | Exeter | England | EX2 5DW | United Kingdom |
| Frimley Park Hospital | Frimley | England | GU16 5UJ | United Kingdom |
| Queen Elizabeth Hospital | Gateshead | England | NE9 6SX | United Kingdom |
| St. Luke's Cancer Centre at Royal Surrey County Hospital | Guildford | England | GU2 7XX | United Kingdom |
| Hereford Hospitals | Hereford | England | HR1 2ER | United Kingdom |
| Princess Royal Hospital at Hull and East Yorkshire NHS Trust | Hull | England | HU8 9HE | United Kingdom |
| Ipswich Hospital | Ipswich | England | IP4 5PD | United Kingdom |
| Royal Lancaster Infirmary | Lancaster | England | LA1 4RP | United Kingdom |
| Leeds Cancer Centre at St. James's University Hospital | Leeds | England | LS9 7TF | United Kingdom |
| Leicester General Hospital | Leicester | England | LE5 4PW | United Kingdom |
| Lincoln County Hospital | Lincoln | England | LN2 5QY | United Kingdom |
| Liverpool Women's Hospital | Liverpool | England | L8 7SS | United Kingdom |
| Saint Bartholomew's Hospital | London | England | EC1A 7BE | United Kingdom |
| Barts and the London School of Medicine | London | England | EC1M 6GR | United Kingdom |
| Medical Research Council Clinical Trials Unit | London | England | NW1 2DA | United Kingdom |
| St. George's Hospital | London | England | SW17 0QT | United Kingdom |
| Royal Marsden - London | London | England | SW3 6JJ | United Kingdom |
| Hammersmith Hospital | London | England | W12 OHS | United Kingdom |
| St. Mary's Hospital | Manchester | England | M13 0JH | United Kingdom |
| Christie Hospital | Manchester | England | M20 4BX | United Kingdom |
| Wythenshawe Hospital | Manchester | England | M23 9LJ | United Kingdom |
| Clatterbridge Centre for Oncology | Merseyside | England | CH63 4JY | United Kingdom |
| James Cook University Hospital | Middlesbrough | England | TS4 3BW | United Kingdom |
| Milton Keynes General Hospital | Milton Keynes | England | MK6 5LD | United Kingdom |
| Northampton General Hospital | Northampton | England | NN1 5BD | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | England | NR4 7UY | United Kingdom |
| Oxford Radcliffe Hospital | Oxford | England | 0X3 7LJ | United Kingdom |
| Derriford Hospital | Plymouth | England | PL6 8DH | United Kingdom |
| Dorset Cancer Centre | Poole Dorset | England | BH15 2JB | United Kingdom |
| Portsmouth Oncology Centre at Saint Mary's Hospital | Portsmouth Hants | England | PO3 6AD | United Kingdom |
| Whiston Hospital | Prescot Merseyside | England | L35 5DR | United Kingdom |
| Rosemere Cancer Centre at Royal Preston Hospital | Preston | England | PR2 9HT | United Kingdom |
| Oldchurch Hospital | Romford | England | RM7 OBE | United Kingdom |
| Cancer Research Centre at Weston Park Hospital | Sheffield | England | S10 2SJ | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | England | S1O 2JF | United Kingdom |
| Royal Shrewsbury Hospital | Shrewsbury | England | SY3 8XQ | United Kingdom |
| Wexham Park Hospital | Slough, Berkshire | England | SL2 4HL | United Kingdom |
| Staffordshire General Hospital | Stafford | England | ST16 3SA | United Kingdom |
| University Hospital of North Staffordshire | Stoke-on-Trent | England | ST4 7LN | United Kingdom |
| St. Peter's Hospital | Surrey | England | KT 16 OPZ | United Kingdom |
| Great Western Hospital | Swindon | England | SN3 6BB | United Kingdom |
| Taunton and Somerset Hospital | Taunton Somerset | England | TA1 5DA | United Kingdom |
| Torbay Hospital | Torquay | England | TQ2 7AA | United Kingdom |
| Walsall Manor Hospital | Walsall | England | WS2 9PS | United Kingdom |
| Good Hope Hospital | West Midlands | England | B75 7RR | United Kingdom |
| Southend University Hospital NHS Foundation Trust | Westcliff-on-Sea | England | SS0 0RY | United Kingdom |
| Yeovil District Hospital | Yeovil | England | BA21 4AT | United Kingdom |
| Centre for Cancer Research and Cell Biology at Queen's University Belfast | Belfast | Northern Ireland | BT9 7BL | United Kingdom |
| Aberdeen Royal Infirmary | Aberdeen | Scotland | AB25 2ZN | United Kingdom |
| Ninewells Hospital | Dundee | Scotland | DD1 9SY | United Kingdom |
| Raigmore Hospital | Inverness | Scotland | 1V2 3UJ | United Kingdom |
| Ysbyty Gwynedd | Bangor | Wales | LL57 2PW | United Kingdom |
| University Hospital of Wales | Cardiff | Wales | CF14 4XW | United Kingdom |
| Velindre Cancer Center at Velindre Hospital | Cardiff | Wales | CF4 7XL | United Kingdom |
| South West Wales Cancer Institute | Swansea | Wales | SA2 8QA | United Kingdom |
| Wrexham Maelor Hospital | Wrexham | Wales | LL13 7TD | United Kingdom |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D017024 | Chemotherapy, Adjuvant |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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