Paclitaxel plus carboplatin (TC) therapy versus irinotecan plus cisplatin (CPT-P) therapy as a first-line chemotherapy in clear cell ovarian cancer

ISRCTN	ISRCTN52615671
DOI	https://doi.org/10.1186/ISRCTN52615671
EudraCT/CTIS number	2007-007849-13
Secondary identifying numbers	5275

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 25/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/A-trial-comparing-two-combinations-chemotherapy-clear-cell-ovarian-cancer

Contact information

Ms Karen Carty
Scientific

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Randomised phase III trial of paclitaxel plus carboplatin (TC) therapy versus irinotecan plus cisplatin (CPT-P) therapy as a first-line chemotherapy for clear cell carcinoma of the ovary
Study acronym	CCC-1 (JGOG 3017/GCIG)
Study objectives	To compare the efficacy and safety of standard arm of paclitaxel plus carboplatin and experimental arm of irinotecan plus cisplatin in clear cell carcinoma of the ovary. Primary objective: progression-free survival Secondary objectives: overall survival, response assessment, adverse events (frequency and grade)
Ethics approval(s)	North West 5 Research Ethics Committee, 11/11/2008, ref: 08/H1010/100
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary
Intervention	Experimental arm: Irinotecan 60 mg/m^2 intravenous (IV) on days 1, 8 and 15 Cisplatin 60 mg/m^2 IV on day 1 This combination is given every 4 weeks (28 days) for 6 cycles. Patients will be followed up for 2.25 years after completing or discontinuing the study treatment. Standard arm: Paclitaxel: 175 mg/m^2 IV on day 1 Carboplatin: AUC 6 IV on day 1 This combination given every 3 weeks (21 days) for 6 cycles. Patients will be followed up for 2.25 years after completing or discontinuing the study treatment. Follow-up length: 27 months Study entry: registration and one or more randomisations
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Paclitaxel, carboplatin, irinotecan, cisplatin
Primary outcome measure	Progression-free survival: patients are followed up clinically every 2 months until disease progression
Secondary outcome measures	1. Adverse events: adverse event data will be collected during the treatment phase of the study 2. Overall survival: patients will be followed up at least until 36 months post-treatment 3. Response rate: to confirm best response to treatment, patients are scanned (computed tomography [CT]/magnetic resonance imaging [MRI]) pre-treatment
Overall study start date	10/05/2010
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned sample size: 652; UK sample size: 120
Total final enrolment	667
Key inclusion criteria	1. Patients with a histological diagnosis of clear cell carcinoma of the ovary, International Federation of Gynecology and Obstetrics (FIGO) stage I to IV. All patients must have have had a appropriate surgery for ovarian carcinoma with appropriate tissue available for histological evaluation. For patients participating in the trial from the UK, Central Pathology Review will take place prior to entry to confirm patients' eligibility. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1 3. Reasonable organ function: must be assessed within 14 days of registration 4. Patients must have signed informed consent 5. Patients must be enrolled within 6 weeks of comprehensive surgery 6. Females aged over 18 years
Key exclusion criteria	1. Patients with a current diagnosis of epithelial ovarian cancer of low malignant potential (borderline carcinomas) 2. Patients with a synchronous primary endometrial cancer, or a past history of primary endometrial cancer 3. Prior chemotherapy or radiation to treat the current disease 4. Patients who received intraperitoneal chemotherapy at time of operation 5. Prior diagnosis of malignancy (other than non-melanoma skin cancer or other malignancies curatively treated and greater than 5 years without evidence of recurrence) 6. Patients with diarrhoea greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 7. Patients who have received prior radiotherapy 8. Patients who have received prior chemotherapy 9. Patients with an active infection which requires antibiotics
Date of first enrolment	10/05/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

France
Japan
Korea, South
Scotland
United Kingdom

Study participating centre

Gartnavel General Hospital

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Sponsor information

Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)
Hospital/treatment centre

300 Balgray Hill Road
Glasgow
G21 3UR
Scotland
United Kingdom

Website	http://www.ngt.org
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C10382/A8964)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	20/08/2016		Yes	No
Plain English results			25/10/2022	No	Yes
HRA research summary			28/06/2023	No	No

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
13/03/2017: Publication reference added.