Condition category
Cancer
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
20/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.eortc.be/protoc/Details.asp?Protocol=55971

Contact information

Type

Scientific

Primary contact

Mr Gavin Shreeves

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

921; EORTC 55971

Study information

Scientific title

Randomised phase III study comparing upfront debulking surgery versus neo-adjuvant chemotherapy in patients with epithelial ovarian carcinoma

Acronym

Study hypothesis

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

North West MREC approved on the 18th February 2000 (ref: 99/8/73). All other centres will seek ethics approval before recruiting participants.

Study design

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

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

21/09/1998

Overall trial end date

06/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 720; UK Sample Size: 65

Participant 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

Recruitment start date

21/09/1998

Recruitment end date

06/12/2006

Locations

Countries of recruitment

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

Trial participating centre

Department of Medical Oncology
Northwood
HA6 2RN
United Kingdom

Sponsor information

Organisation

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

Sponsor details

Avenue Mounierlaan
83/11
Brussels
1200
Belgium

Sponsor type

Research organisation

Website

http://www.eortc.be/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

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

Publication citations

Additional files

Editorial Notes

20/07/2016: Publication reference added