Condition category
Cancer
Date applied
17/10/2006
Date assigned
14/12/2006
Last edited
04/06/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Christopher Poole

ORCID ID

Contact details

Clinical Sciences Research Institute
Clinical Sciences Building
University Hospital Coventry - Walsgrave Campus
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 967496
cjpoole@mac.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00838656

Protocol/serial number

OV2039; AK/RH/22498/1

Study information

Scientific title

A randomised feasibility study of extended chemotherapy with neoadjuvant carboplatin, then surgery followed by adjuvant paclitaxel and gemcitabine versus neoadjuvant gemcitabine and carboplatin, then surgery, followed by adjuvant paclitaxel for women with epithelial non-mucinous advanced inoperable peritoneal malignancy

Acronym

Neo-Escape

Study hypothesis

1. Up to 12 cycles of chemotherapy in a six plus six sequential schedule of platinum then paclitaxel based chemotherapy are tolerable and feasible for most patients.
2. The addition of gemcitabine to either carboplatin induction or the paclitaxel consolidation/adjuvant phase may enhance the overall activity of such a sequential schedule.

On 23/06/2009 this record was updated. All updates can be found under the relevant section with the above update date. Please also note that at this time, the overall trial end date was updated; the intial end date at the time of registration was 01/03/2009.

On 15/02/2011 the overall trial end date was extended from 31/03/2011 to 30/09/2011.

Ethics approval

Warwickshire Research Ethics Committee, 06/08/2007, ref: 07/Q2803/73

Study design

Randomised two-arm feasibility study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Advanced, inoperable ovarian cancer (epithelial non-mucinous advanced inoperable peritoneal malignancy)

Intervention

Group one: six cycles of chemotherapy with neoadjuvant carboplatin, then surgery, followed by six cycles of adjuvant paclitaxel and gemcitabine
Group two: six cycles of neoadjuvant gemcitabine and carboplatin, then surgery, followed by six cycles of adjuvant paclitaxel

On 23/06/2009 this record was updated to include a new sponsor; the initial sponsor at the time of registration was the University of Birmingham (UK).

Intervention type

Drug

Phase

Phase II

Drug names

Carboplatin, paclitaxel and gemcitabine

Primary outcome measures

The percentage of patients completing 12 cycles of chemotherapy in each study arm, considered separately.

Secondary outcome measures

1. Toxicities
2. Quality of life
3. Objective response rate to the induction phase of chemotherapy (first six cycles) assessed on Computed Tomography (CT), clinically, at surgery, and using CA-125 tumour marker
4. Objective response rate following all 12 (six plus six) cycles of treatment, assessed clinically, on CT and using CA-125
5. Progression-free and overall survival, particularly at 34 weeks (end of treatment)
These will be assessed separately for each treatment arm.

Overall trial start date

01/03/2007

Overall trial end date

25/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical, radiological, histological and findings consistent with a diagnosis of International Federation of Gynecology and Obstetrics (FIGO) stage 3C/4 primary epithelial ovarian cancer, primary peritoneal carcinoma, ovarian carcinosarcoma, or fallopian tube carcinoma
2. Patients (aged 18 - 75 years) will be unsuitable for primary debulking surgery as defined by laparoscopic staging procedures, supplemented by clinical and radiological assessments
3. Eastern Cooperative Oncology Group (ECOG) performance status zero, one, two or three

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

88

Participant exclusion criteria

1. Prior malignancy, chemotherapy or radiotherapy
2. Known brain metastases
3. Poorly controlled potentially serious medical conditions likely to render treatment compliance with the protocol difficult
4. Those of child-bearing potential not employing adequate contraception, which may include prescription contraceptives

Recruitment start date

03/12/2007

Recruitment end date

25/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital Coventry
Coventry
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick (UK)

Sponsor details

Clinical Sciences Research Institute
Clinical Science Building (1st Floor)
University Hospital Coventry - Walsgrave Campus
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
+44 (0)2476 968638/20
h.higgins@warwick.ac.uk

Sponsor type

University/education

Website

http://www2.warwick.ac.uk/

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C1582/A5678)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes