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

Completed

Conditions: Oesophageal cancer
Cancer
Malignant neoplasm of oesophagus

Registration Number: ISRCTN45750457

Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

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

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%

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>These primary endpoints will quantify the diagnostic potential and clinical applicability / usefulness of each technique to predict early treatment response.

Secondary Outcome Measures