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
Clinical Trials Information System (CTIS)	2007-007849-13
Protocol serial number	5275
Sponsor	Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)
Funder	Cancer Research UK (CRUK) (UK) (ref: C10382/A8964)

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

Primary study design	Interventional
Study design	Multicentre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Paclitaxel, carboplatin, irinotecan, cisplatin
Primary outcome measure(s)	Progression-free survival: patients are followed up clinically every 2 months until disease progression
Key secondary outcome measure(s)	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
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	652
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

United Kingdom
Scotland
France
Japan
Korea, South

Study participating centre

Gartnavel General Hospital

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
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
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			25/10/2022	No	Yes

Editorial Notes

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