Accuracy of FDG-PET and spiral CT for the early prediction of non-response to preoperative chemoradiotherapy in patients with oesophageal cancer

ISRCTN	ISRCTN45750457
DOI	https://doi.org/10.1186/ISRCTN45750457
Secondary identifying numbers	NTR253

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 10/08/2009

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J. M. T. Omloo
Scientific

Academic Medical Center
UvA
Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5663405
Email	j.m.omloo@amc.uva.nl

Study information

Study design	Multicentre randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title
Study acronym	NEOPEC
Study objectives	To compare FDG-PET and CT-scan for the early prediction of non-response to preoperative chemoradiotherapy in patients with potentially curable oesophageal cancer.
Ethics approval(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Oesophageal cancer
Intervention	150 consecutive patients will be included in this prognostic accuracy study over a 3 year period. FDG-PET and CT-scan will be performed independently before and 2 weeks after the start of the chemo radiotherapy. All patients complete the 5 weeks regimen of neoadjuvant chemo radiotherapy, regardless the test results.
Intervention type	Other
Primary outcome measure	The accuracy of serial FDG-PET and CT-scan for the early prediction of response versus non-response to preoperative chemoradiotherapy. The negative predictive value of serial FDG-PET and CT-scan for non-response. These primary endpoints will quantify the diagnostic potential and clinical applicability / usefulness of each technique to predict early treatment response.
Secondary outcome measures	The correlation between histological tumor response in the resection specimen and long term survival.
Overall study start date	01/01/2005
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	150
Key inclusion criteria	1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic oesophagus. 2. Surgical resectable (T2-3, N0-1, M0), as determined by Endoscopic Ultra Sound (EUS). 3. T1N1 are eligible. (T1N0 tumors and tumors in situ are not elligible). Tumor length longitudinal <8 cm and radial < 5 cm 4. If the tumor extends below the gastroesophageal(GE) junction into the proximal stomach, the bulk of the tumor must involve the oesophagus or GE junction. The tumor must not extend > 2 cm into the stomach. Gastric cancers with minor involvement of the GE junction or distal esophagus are not eligible. 5. No invasion of the tracheobronchial tree or presence of tracheoesophageal fistula. 6. Non pregnant, non-lactating female patients. Sexually active patients of childbearing potential must implement effective contraceptive practices during the study when treated with chemotherapy. 7. Age <18 and >75 8. ECOG performance status of 0-2 9. Granulocytes > 1.5 x 109/l 10. Platelets > 100 x 109/l 11. Total bilirubin < 1.5 x ULN 12. Creatinine <120 µmol/L 13. FEV1 > 1,5 L 14. Written, voluntary informed consent. 15. Patients must be accessible to follow up and management in the treatment center. 16. Patients must sufficiently understand the Dutch language to fill in quality of life questionnaires
Key exclusion criteria	1. Past or current history of malignancy other than entry diagnosis except for non-melanomatous skin cancer, or curatively treated carcinoma in situ of the cervix or a cured" malignancy more than 5 years prior to enrollment 2. Previous chemotherapy and radiotherapy 3. New York Heart Association Class lll/lV and no history of active angina 4. Documented myocardial infarction within 6 months preceding registration (pretreatment ECG evidence of infarct only will not exclude patients) 5. Patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure History of 2nd or 3rd degree heart blocks 6. Pre-existing motor or sensory neurotoxicity greater than WHO grade 1 7. Active infection or other serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporin 8. Dementia or altered mental status that would prohibit the understanding and giving of informed consent 9. Inadequate caloric- and/ or fluid intake 10. Weight loss > 10%
Date of first enrolment	01/01/2005
Date of final enrolment	01/01/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center

Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Research organisation

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

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?
Protocol article	Protocol	31/07/2008		Yes	No