Randomisation

To access the ICON6 web-based randomisation system, click here:

http://www.clinphone.com/

Click here for telephone numbers to access the ICON6 telephone randomisation system:

http://www.clinphone.com/support/phones

Patients will be randomly assigned in a 2:3:3 ratio to:

1. Platinum-based chemotherapy plus placebo during chemotherapy and for 18 months post randomisation or until progression  (Arm A – reference arm)
2. Platinum-based chemotherapy plus cediranib during chemotherapy and then placebo  for 18 months post randomisation or until progression  (Arm B – concurrent arm)
3. Platinum-based chemotherapy plus cediranib during chemotherapy and then continuing for 18 months post randomisation or until progression (Arm C – concurrent and maintenance arm) 

Trial Drug (placebo or cediranib) continues for 18 months, or can continue beyond 18 months until disease progression if the clinician feels there is continuing clinical benefit and the patient wishes to continue.

Patients can only be enrolled once on this trial. The patient randomisation numbers will be allocated sequentially in the order in which the patients are enrolled.  Co-enrolment in any other clinical trial is not allowed (see 8.7 of the ICON6 protocol for details).

The following data will be required in order to enrol a patient:

1. Confirmation (yes or no) that the patient satisfies all the eligibility criteria
2. Patient’s date of birth
3. Patient’s initials
4. Date and evidence of recurrence (confirm that this is greater than 6 months since the completion of first-line treatment)
5. Details of first line treatment of ovarian cancer
6. Planned chemotherapy regimen (platinum alone, platinum plus paclitaxel or platinum plus gemcitabine)
7. Confirmation (yes/no) of whether the patient has previously received any VEGF inhibitors

The date of commencing treatment should be as soon as possible after the patient is randomised, and must be within two weeks. This date should not be affected by the treatment arm the patient is allocated to.

Patients will be randomised using ClinPhone IVRS/IWRS system, via computer key-board data entry for web-based interface or touch-tone phone key pad. See top of page for information on how to access the ICON6 randomisation system.

The randomisation database is linked to the Trial Drug supply management database.

Each member of the trial site team who is authorised to randomise patients will be provided with a unique system username and password, which will allow them to access the central randomisation system 24 hours per day, 7 days per week via the trial specific Internet site.

Site staff will be trained in how to access and use the randomisation system. After receiving training site staff will be provided with a randomisation system and drug supply management user-guide and a free-phone help-desk number.