Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
10/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

01/01/2008

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

http://www.amc.uva.nl/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18671847

Publication citations

  1. Protocol

    van Heijl M, Omloo JM, van Berge Henegouwen MI, Busch OR, Tilanus HW, Bossuyt PM, Hoekstra OS, Stoker J, Hulshof MC, van der Gaast A, Nieuwenhuijzen GA, Bonenkamp HJ, Plukker JT, Bilgen EJ, Ten Kate FJ, Boellaard R, Pruim J, Sloof GW, van Lanschot JJ, NEOadjuvant therapy monitoring with PET and CT in Esophageal Cancer (NEOPEC-trial)., BMC Med Phys, 2008, 8, 3, doi: 10.1186/1756-6649-8-3.

Additional files

Editorial Notes