Upfront debulking surgery versus neoadjuvant chemotherapy in ovarian cancer

ISRCTN	ISRCTN67331344
DOI	https://doi.org/10.1186/ISRCTN67331344
Secondary identifying numbers	921; EORTC 55971

Submission date: 23/04/2010
Registration date: 23/04/2010
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mr Gavin Shreeves
Scientific

Department of Medical Oncology
Rickmansworth Road
Northwood
HA6 2RN
United Kingdom

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised phase III study comparing upfront debulking surgery versus neo-adjuvant chemotherapy in patients with epithelial ovarian carcinoma
Study objectives	This is a randomised phase III study comparing upfront debulking surgery versus neo-adjuvant chemotherapy in patients with Stage IIIc or IV epithelial ovarian carcinoma.
Ethics approval(s)	North West MREC approved on the 18th February 2000 (ref: 99/8/73). All other centres will seek ethics approval before recruiting participants.
Health condition(s) or problem(s) studied	Topic: National Cancer Research Network; Subtopic: Gynaecological Cancer; Disease: Ovary
Intervention	Arm A: upfront maximal cytoreductive surgery - 3 courses of platinum-containing chemo (3-weekly): 1. Paclitaxel 135 mg/m^2 (over 24 hours) then cisplatin 75 mg/m^2, or 2. Paclitaxel 175 mg/m^2 (over 3 hours) then cisplatin 75 mg/m^2, or 3. Paclitaxel 175 mg/m^2 (over 3 hours) then carboplatin AUC 5 Interval debulking if initial surgery was not optimal. 3 courses of platinum-containing chemotherapy (as above) and 2nd look surgery is allowed. Arm B: no upfront maximal cytoreductive surgery - 3 courses of platinum-containing chemo (3-weekly): 1. Paclitaxel 135 mg/m^2 (over 24 hours) then cisplatin 75 mg/m^2, or 2. Paclitaxel 175 mg/m^2 (over 3 hours) then cisplatin 75 mg/m^2, or 3. Paclitaxel 175 mg/m^2 (over 3 hours) then carboplatin AUC 5 Interval debulking surgery. 3 courses platinum-containing chemotherapy (as above) and 2nd look surgery is allowed. Follow-up every 3 months the first 2 years; every 6 months year 3 - 5; yearly afterwards. Computed tomography (CT) scans were performed at screening, after cycle 3, after interval debulk (if perfomed) and after cycle 6. Progression defined according to Response Evaluation Criteria in Solid Tumours (RECIST) guidelines for CT or clinical signs/symptoms on physical examination during follow-up. CA-125 tumour markers were measured at screening, before each cycle and at every follow-up visit. Progression on rising CA-125 (criteria in protocol). Time to progression will be defined as the time to clinically, CA125 or surgically defined PD, whichever occurs first. Overall survival is defined as the time from randomisation to the time of death of any cause. Overall survival will be censored at the last follow-up assessment at which the patient was known to be alive.
Intervention type	Other
Primary outcome measure	Overall crude survival
Secondary outcome measures	1. Progression-free survival 2. Quality of life according to the EORTC questionnaire QLQ-C30 3. To assess the different treatment complications in relation to treatment arm
Overall study start date	21/09/1998
Completion date	06/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	Planned Sample Size: 720; UK Sample Size: 65
Key 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
Key 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
Date of first enrolment	21/09/1998
Date of final enrolment	06/12/2006

Locations

Countries of recruitment

Argentina
Austria
Belgium
Canada
Denmark
England
France
Germany
Ireland
Italy
Netherlands
Norway
Portugal
Spain
Sweden
United Kingdom

Study participating centre

Department of Medical Oncology

Northwood
HA6 2RN
United Kingdom

Sponsor information

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Research organisation

Avenue Mounierlaan, 83/11
Brussels
1200
Belgium

Website	http://www.eortc.be/
"ROR"	https://ror.org/034wxcc35

Funders

Funder type

Government

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Results article	results	01/01/2008		Yes	No

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
20/07/2016: Publication reference added