A phase I trial testing TH-302, a tumor-selective Hypoxia-Activated cytotoxic Prodrug, in combination with preoperative chemoradiotherapy in patients with distal esophageal and esophago-gastric junction adenocarcinoma

Withdrawn

• Conditions: esophageal cancer; 10017991

• Registration Number: NL-OMON41947
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 18

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

*Recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
*Patients with difficult peripheral intravenous access
*History of prior thoracic radiotherapy
*Severe chronic obstructive pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state leading to hypoxemia
*Women who are pregnant or lactating
*Known infection with HIV, hepatitis B or C or any other active infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified