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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00098878




Registration number
NCT00098878
Ethics application status
Date submitted
8/12/2004
Date registered
9/12/2004
Date last updated
7/08/2013

Titles & IDs
Public title
Carboplatin in Treating Patients With Stage IC-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Scientific 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
Secondary ID [1] 0 0
CDR0000396778
Secondary ID [2] 0 0
SCOTTISH-SCOTROC-4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fallopian Tube Cancer 0 0
Ovarian Cancer 0 0
Primary Peritoneal Cavity Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - carboplatin

Treatment: Drugs: carboplatin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Toxicity
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Quality of life
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Clinical overall response rate and CA125 response
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
1300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Sydney Heamatology and Oncology Clinics - Hornsby
Recruitment hospital [2] 0 0
Lismore Base Hospital - Lismore
Recruitment hospital [3] 0 0
Institute of Oncology at Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [5] 0 0
Sydney Cancer Centre at Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Tamworth Base Hospital - Tamworth
Recruitment hospital [7] 0 0
Manning Base Hospital - Taree
Recruitment hospital [8] 0 0
Newcastle Mater Misericordiae Hospital - Waratah
Recruitment hospital [9] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Wentworthville
Recruitment hospital [10] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [11] 0 0
Townsville Hospital - Douglas
Recruitment hospital [12] 0 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [13] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [14] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [15] 0 0
Ballarat Oncology and Haematology Services - Ballarat
Recruitment hospital [16] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [17] 0 0
Royal Women's Hospital - Carlton
Recruitment hospital [18] 0 0
Monash Medical Center - Clayton Campus - Clayton
Recruitment hospital [19] 0 0
Frankston Hospital - Frankston
Recruitment hospital [20] 0 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [21] 0 0
Murray Valley Private Hospital and Cancer Treatment Centre - Wodonga
Recruitment postcode(s) [1] 0 0
2077 - Hornsby
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
2050 - Sydney
Recruitment postcode(s) [6] 0 0
2340 - Tamworth
Recruitment postcode(s) [7] 0 0
2430 - Taree
Recruitment postcode(s) [8] 0 0
2298 - Waratah
Recruitment postcode(s) [9] 0 0
2145 - Wentworthville
Recruitment postcode(s) [10] 0 0
4029 - Brisbane
Recruitment postcode(s) [11] 0 0
4814 - Douglas
Recruitment postcode(s) [12] 0 0
4101 - South Brisbane
Recruitment postcode(s) [13] 0 0
5042 - Bedford Park
Recruitment postcode(s) [14] 0 0
7000 - Hobart
Recruitment postcode(s) [15] 0 0
3350 - Ballarat
Recruitment postcode(s) [16] 0 0
3128 - Box Hill
Recruitment postcode(s) [17] 0 0
3053 - Carlton
Recruitment postcode(s) [18] 0 0
3168 - Clayton
Recruitment postcode(s) [19] 0 0
3199 - Frankston
Recruitment postcode(s) [20] 0 0
3084 - Heidelberg
Recruitment postcode(s) [21] 0 0
3690 - Wodonga
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington
Country [5] 0 0
United Kingdom
State/province [5] 0 0
England
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Northern Ireland
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Scotland
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
NHS Greater Glasgow and Clyde
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00098878
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stanley B. Kaye, MD, FRCP
Address 0 0
Royal Marsden NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00098878