pfront debulking surgery versus neoadjuvant chemotherapy in ovarian cancer

Phase 3

Completed

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

• Registration Number: ISRCTN67331344
• Lead Sponsor: European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

Brief Summary

2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18258715

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-12-06
• Study Start: 2010-04-23
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

1. Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
2. If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true:
2.1. Presence of pelvic ovarian mass
2.2. Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis
2.3. CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor)
2.4. Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25)
3. Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan
4. No brain or leptomeningeal metastases
5. No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy
6. Performance status: World Health Organisation (WHO) performance status 0 - 2
7. WBC greater than 3,000/mm3
8. Platelet count greater than 100,000/mm3
9. Bilirubin less than 1.25 times upper limit of normal (ULN)
10. Creatinine less than 1.25 times ULN
11. No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy
12. No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
13. No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up
14. Aged between 18 - 50 years

Exclusion Criteria

1. No other serious disabling diseases contraindicating for primary cytoreductive surgery or primary platin based chemotherapy
2. No other prior primary malignancies, except for carcinoma in situ of the cervix and basal carcinoma of the skin
3. Absence of any psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall crude survival

Secondary Outcome Measures

Name	Time	Method
1. Progression-free survival<br>2. Quality of life according to the EORTC questionnaire QLQ-C30<br>3. To assess the different treatment complications in relation to treatment arm