esophageal cancer
Conditions
Interventions
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: *Histologically proven adenocarcinoma of the esophagus *Age>18 years *UICC T2-4 N0-2 M0, potentially resectable disease *Patient discussed at tumour board (multidisciplinary team meeting) *No evident tumor invasion in nearby regions like aorta, trachea *WHO performance status 0-2 *Less than 10 % weight loss the last 6 months *Laboratory requirements within 7 days prior to enrollment (start chemoradiotherapy): Haemotology: haemoglobin >10g/dl, absolute neutrophils * 1.5 x 109/L,platelets * 100x109/L Biochemistry:bilirubin within normal limits, AST(SGOT)/ALT (SGPT) * 2.5 institutional upper limit, Creatinine clearance * 60 ml/min. *Willing and able to comply with the study prescriptions *No history of prior thoracic radiotherapy *No severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia *Women should not be pregnant or lactating *No known infection with HIV, hepatitis B or C or any other active infection *Normal ECG with careful evaluation of QT/QTc *Have given written informed consent before patient registration
Exclusion criteria
Exclusion criteria: *Recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of *Uncommon grade 3 or higher non-hematological toxicity (according to CTCAE v4.0 see appendix) except for esofagitis where grade III toxicity is already an acceptable toxicity in up to 10% of patients. We accept in this phase I study a grade III esophagitis of 50%. We accept grade 3 nausea and emesis unless standard anti-emetics have been used. *Grade 4 or higher hematological toxicity (according to CTCAE v4.0) *Grade 4 or higher postoperative toxicity within 30 days post-surgery according to the Clavien-Dindo classification . For anastomic leakage we accept a grade IV of 50% and for cardiorespiratory complications up to 30% grade IV will be *Any grade 2 or higher non-hematologic toxicity except for esophagitis that does not resolve to grade 0 or 1 toxicity by the start of the next cycle of chemotherapy which, in judgment of the investigator or sponsor is considered a DLT *Inability to begin the next cycle of chemotherapy of treatment within two weeks of the last dose due to unresolved toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| *Presence of hypoxia response based on quantifiable changes in hypoxia calculated from HX4 images at baseline compared to those at first administration TH-302 (before chemoradiotherapy). *Presence of anti-tumor activity measured by the rate of pathological Complete Remission (pCR), histopathologic negative circumferential resection margin (CRM) rate, local and distance recurrence rate, progression free and overall survival, metabolic response one month after treatment. *Correlation between HX4 PET/CT-scans and serum biomarker expression | — |
Countries
The Netherlands
Outcome results
None listed