Sequential schedule of platinum then paclitaxel-based chemotherapy for women with epithelial non-mucinous advanced inoperable peritoneal malignancy

ISRCTN	ISRCTN24742183
DOI	https://doi.org/10.1186/ISRCTN24742183
ClinicalTrials.gov (NCT)	NCT00838656
Clinical Trials Information System (CTIS)	2005-001875-37
Protocol serial number	OV2039; AK/RH/22498/1
Sponsor	University of Warwick (UK)
Funder	Cancer Research UK (CRUK) (UK) - Clinical Trials Advisory and Awards Committee (CTAAC) (ref: C1582/A5678)

Submission date: 17/10/2006
Registration date: 14/12/2006
Last edited: 19/03/2020

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

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-chemotherapy-before-and-after-surgery-for-advanced-peritoneal-cancer

Contact information

Prof Christopher Poole
Scientific

Clinical Sciences Research Institute
Clinical Sciences Building
University Hospital Coventry - Walsgrave Campus
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Phone	+44 (0)2476 967496
Email	cjpoole@mac.com

Study information

Primary study design	Interventional
Study design	Randomised two-arm feasibility study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	Neo-Escape
Study objectives	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(s)	Warwickshire Research Ethics Committee, 06/08/2007, ref: 07/Q2803/73
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Carboplatin, paclitaxel and gemcitabine
Primary outcome measure(s)	The percentage of patients completing 12 cycles of chemotherapy in each study arm, considered separately.
Key secondary outcome measure(s)	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.
Completion date	25/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Female
Target sample size at registration	88
Key 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
Key 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
Date of first enrolment	03/12/2007
Date of final enrolment	25/05/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University Hospital Coventry

Coventry
CV2 2DX
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	abstract	20/05/2012		No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes

Editorial Notes

19/03/2020: EudraCT number added.
29/10/2019: Internal review.
08/03/2019: Publication reference added.
19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
04/10/2017: No publications found in PubMed, verifying study status with principal investigator.