Contact information
Type
Scientific
Contact name
Dr J. M. T. Omloo
ORCID ID
Contact details
Academic Medical Center
UvA
Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5663405
j.m.omloo@amc.uva.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NTR253
Study information
Scientific title
Acronym
NEOPEC
Study hypothesis
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
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
Patient information sheet
Condition
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
Overall study end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
150
Participant 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%
Recruitment start date
01/01/2005
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol | 31/07/2008 | Yes | No |