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Fallopian Tube CancerPhase 3NCT00098878

Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 3 study testing carboplatin in people with Fallopian Tube Cancer and Ovarian Cancer, run by NHS Greater Glasgow and Clyde at 88 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
carboplatin
How many people
1,300 participants
Where
88 sitesin 3 countries
Study dates
Mar 2004to Jul 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer*
  • Stage IC-IV disease
  • Peritoneal carcinomatosis* (ovarian-type) must not be a mucin-secreting tumor
  • Stage IC patients must have malignant cells in ascitic fluid or peritoneal washings, tumor on the surface of the ovary, or preoperative capsule rupture NOTE: * Histologic confirmation of a primary source in the ovary is not required.
  • If biospy is not available, cytology showing an adenocarcinoma is allowed provided the following criteria is met:
  • Patient has a pelvis (ovarian) mass AND all of the following:
  • Omental cake or other metastasis is larger than 2 cm in the upper abdomen and/or regional lymph node metastasis irrespective of size OR stage IV disease
  • Serum CA 125/CEA ratio > 25 or barium enema (or colonoscopy) and gastroscopy (or radiological examination of the stomach) are negative for the presence of a primary tumor and normal mammography within 6 weeks prior to study randomization
  • Initial cytoreductive laparotomy or biopsy required within the past 8 weeks
  • Cytoreductive surgery may or may not have been successful during staging laparotomy
  • No mixed mesodermal tumors
  • No borderline ovarian tumors or tumors termed "possibly malignant"
  • No adenocarcinoma of unknown origin, if histologically confirmed to be a mucin-secreting tumor
  • Considered unsuitable for or unwilling to receive platinum-taxane combination therapy
  • No concurrent endometrial cancer

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 times ULN

Renal

  • Creatinine clearance ≥ 30 mL/min
  • Obstructive hydronephrosis as a cause of borderline (i.e., creatinine clearance 30-45 mL/min) renal function must be treated before study entry

Cardiovascular

  • No hypertension
  • No ischemic heart disease
  • No myocardial infarction within the past 6 months
  • No congestive heart failure

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No symptomatic peripheral neuropathy ≥ grade 2
  • No uncontrolled infection
  • No other severe and/or uncontrolled medical condition
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy
  • No other concurrent cytotoxic chemotherapy until progressive disease occurs

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy

Surgery

  • See Disease Characteristics

Trial locations and contacts

88 sites in 3 countries.

88 sites in 3 countries

United Kingdom63 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Ysbyty Gwynedd

    Bangor, Wales, LL57 2PW

  • Furness General Hospital

    Barrow in Furness, England, LA14 4LF

  • Royal United Hospital

    Bath, England, BA1 3NG

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

    Belfast, Northern Ireland, BT9 7BL

  • Birmingham Heartlands Hospital

    Birmingham, England, B9 5SS

  • Royal Blackburn Hospital

    Blackburn, England, BB2 3HH

  • Blackpool Victoria Hospital

    Blackpool, England, FY3 8NR

  • Bradford Royal Infirmary

    Bradford, England, BD9 6RJ

  • Sussex Cancer Centre at Royal Sussex County Hospital

    Brighton, England, BN2 5BE

  • Bristol Haematology and Oncology Centre

    Bristol, England, BS2 8ED

  • Broomfield Hospital

    Broomfield, England, CM1 7ET

  • Queen's Hospital

    Burton-on-Trent, England, DE13 0RB

  • Velindre Cancer Center at Velindre Hospital

    Cardiff, Wales, CF4 7XL

  • West Wales General Hospital

    Carmarthen, Wales, SA31 2AF

  • Cheltenham General Hospital

    Cheltenham, England, GL53 7AN

  • Essex County Hospital

    Colchester, England, C03 3NB

  • Walsgrave Hospital

    Coventry, England, CV2 2DX

  • Derbyshire Royal Infirmary

    Derby, England, DE1 2QY

  • Dorset County Hospital

    Dorchester, England, DT1 2JY

  • Russells Hall Hospital

    Dudley, England, DY1 2HQ

  • Dumfries & Galloway Royal Infirmary

    Dumfries, Scotland, DG1 4AP

  • Ninewells Hospital

    Dundee, Scotland, DD1 9SY

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XR

  • Gartnavel General Hospital

    Glasgow, Scotland, G12 0YN

  • Gloucestershire Royal Hospital

    Gloucester, England, GL1 3NN

  • Hereford Hospitals NHS Trust

    Hereford, England, HR1 2ER

  • Huddersfield Royal Infirmary

    Huddersfield, West Yorks, England, HD3 3EA

  • Raigmore Hospital

    Inverness, Scotland, 1V2 3UJ

  • Ipswich Hospital

    Ipswich, England, IP4 5PD

  • Airedale General Hospital

    Keighley, England, BD20 6TD

  • Royal Lancaster Infirmary

    Lancaster, England, LA1 4RP

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

  • Liverpool Women's Hospital

    Liverpool, England, LV8 7SS

  • Saint Bartholomew's Hospital

    London, England, EC1A 7BE

  • University College of London Hospitals

    London, England, NW1 2PG

  • Guy's Hospital

    London, England, SE1 9RT

  • St. Georges, University of London

    London, England, SW17 0QT

  • Hammersmith Hospital

    London, England, W12 OHS

  • Mid Kent Oncology Centre at Maidstone Hospital

    Maidstone, England, ME16 9QQ

  • Christie Hospital

    Manchester, England, M20 4BX

  • Queen Elizabeth The Queen Mother Hospital

    Margate, England, CT9 4AN

  • Clatterbridge Centre for Oncology

    Merseyside, England, CH63 4JY

  • Northampton General Hospital NHS Trust

    Northampton, England, NN1 5BD

  • Mount Vernon Cancer Centre at Mount Vernon Hospital

    Northwood, England, HA6 2RN

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Kings Mill Hospital

    Nottinghamshire, England, NG17 4JL

  • George Eliot Hospital

    Nuneaton, England, CV10 7DJ

  • Whiston Hospital

    Prescot Merseyside, England, L35 5DR

  • Rosemere Cancer Centre at Royal Preston Hospital

    Preston, England, PR2 9HT

  • Alexandra Healthcare NHS

    Redditch, Worcestershire, England, B98 7UB

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

  • Wexham Park Hospital

    Slough, Berkshire, England, SL2 4HL

  • Royal Marsden - Surrey

    Sutton, England, SM2 5PT

  • South West Wales Cancer Institute

    Swansea, Wales, SA2 8QA

  • Taunton and Somerset Hospital

    Taunton Somerset, England, TA1 5DA

  • South Warwickshire Hospital

    Warwick, Warwickshire, England, CV34 5BJ

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

  • Weston General Hospital

    Weston-super-Mare, England, BS23 4TQ

  • Worcester Royal Hospital

    Worcester, England, WR5 1DD

  • Worthing Hospital

    Worthing, England, BN11 2DH

  • Yeovil District Hospital

    Yeovil - Somerset, England, BA21 4AT

Other trials in United Kingdom

Australia21 sites

  • Ballarat Oncology and Haematology Services

    Ballarat, Victoria, 3350

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Royal Women's Hospital

    Carlton, Victoria, 3053

  • Monash Medical Center - Clayton Campus

    Clayton, Victoria, 3168

  • Townsville Hospital

    Douglas, Queensland, 4814

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Mercy Hospital for Women

    Heidelberg, Victoria, 3084

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Sydney Heamatology and Oncology Clinics

    Hornsby, New South Wales, 2077

  • Lismore Base Hospital

    Lismore, New South Wales, 2480

  • Institute of Oncology at Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Mater Adult Hospital

    South Brisbane, Queensland, 4101

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Sydney Cancer Centre at Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • Tamworth Base Hospital

    Tamworth, New South Wales, 2340

  • Manning Base Hospital

    Taree, New South Wales, 2430

  • Newcastle Mater Misericordiae Hospital

    Waratah, New South Wales, 2298

  • Westmead Institute for Cancer Research at Westmead Hospital

    Wentworthville, New South Wales, 2145

  • Murray Valley Private Hospital and Cancer Treatment Centre

    Wodonga, Victoria, 3690

Other trials in Australia

New Zealand4 sites

  • Auckland City Hospital

    Auckland, 1

  • Christchurch Hospital

    Christchurch, 1

  • Waikato Hospital

    Hamilton, 2020

  • Wellington Cancer Centre

    Wellington, 6039

Other trials in New Zealand

About this study

Official title: SCOTROC 4: A Prospective, Multicentre, Randomised Trial Of Carboplatin Flat Dosing Vs Intrapatient Dose Escalation In First Line Chemotherapy Of Ovarian, Fallopian Tube And Primary Peritoneal Cancers

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This randomized phase III trial is comparing different doses of carboplatin to see how well they work in treating patients with stage IC, stage II, stage III, or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare progression-free survival of patients with stage IC-IV ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with flat-dose vs intra-patient dose-escalated carboplatin as first-line chemotherapy.

Secondary

  • Compare the toxic effects of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare overall clinical response rate and CA 125 response in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive a flat dose of carboplatin on day 1.
  • Arm II: Patients receive intra-patient dose-escalated carboplatin on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each treatment course, and then at 2 months post-chemotherapy.

Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study.

Being tested
carboplatin
Keywords
stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, fallopian tube cancer, primary peritoneal cavity cancer
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

Secondary outcomes (4)

  1. Toxicity

  2. Quality of life

  3. Clinical overall response rate and CA125 response

  4. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098878
Sponsor's protocol ID
SCOTTISH-SCOTROC-4
Other IDs
CDR0000396778, EU-20402, ISRCTN47645935
Status last verified
Jul 2009
First submitted
8 Dec 2004
Last updated
7 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin in people with Fallopian Tube Cancer and Ovarian Cancer, run by NHS Greater Glasgow and Clyde at 88 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United Kingdom, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098878.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.

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