Condition category
Cancer
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
26/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Karen Carty

ORCID ID

Contact details

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

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 below 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 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

10/05/2010

Overall trial end date

31/12/2010

Reason abandoned

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

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

http://www.ngt.org

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes