Paclitaxel plus carboplatin (TC) therapy versus irinotecan plus cisplatin (CPT-P) therapy as a first-line chemotherapy in clear cell ovarian cancer

Phase 3

Completed

• Conditions: Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary; Cancer; Ovarian cancer

• Registration Number: ISRCTN52615671
• Lead Sponsor: Greater Glasgow Health Board (North Glasgow University Hospitals Division) (UK)

Brief Summary

2016 Results article in https://www.ncbi.nlm.nih.gov/pubmed/27400948 results

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-12
• Study Completion: 2010-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 667

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified