Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Karen Carty


Contact details

1053 Great Western Road
G12 0YN
United Kingdom

Additional identifiers

EudraCT number

2007-007849-13 number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary


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



Phase III

Drug names

Paclitaxel, carboplatin, irinotecan, cisplatin

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

France, Japan, Korea, South, United Kingdom

Trial participating centre

1053 Great Western Road
G12 0YN
United Kingdom

Sponsor information


Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)

Sponsor details

300 Balgray Hill Road
G21 3UR
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cancer Research UK (CRUK) (UK) (ref: C10382/A8964)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes