Plain English Summary
Trial website
Additional identifiers
EudraCT number
2007-007849-13
ClinicalTrials.gov number
Protocol/serial number
5275
Study information
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
Acronym
CCC-1 (JGOG 3017/GCIG)
Study hypothesis
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
North West 5 Research Ethics Committee, 11/11/2008, ref: 08/H1010/100
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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 names
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 trial start date
10/05/2010
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned sample size: 652; UK sample size: 120
Participant 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
Recruitment start date
10/05/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
France, Japan, Korea, South, United Kingdom
Trial participating centre
Gartnavel General Hospital
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
Sponsor information
Organisation
Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)
Sponsor details
300 Balgray Hill Road
Glasgow
G21 3UR
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C10382/A8964)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27400948