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Testing TH-302, in Combination With Preoperative Chemoradiotherapy, in Esophageal Cancer.

NCT02598687 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-04-21

No results posted yet for this study

Summary

Open-label, single-center phase 1 study of an investigational agent TH-302 and standard chemoradiotherapy with a 3+3 dose escalation design through 3 dose levels.

Conditions

  • Esophageal Cancer

Interventions

DRUG

TH-302

TH-302 day 4 (pre-treatment) and weekly during chemo-radiotherapy (CRT)

OTHER

HX4 scan

HX 4 scan day 1 and day 8

DRUG

Carboplatin

2mg/ml/min

DRUG

Paclitaxel

50 mg/m2

RADIATION

Radiotherapy

23 x 1.8 Gy

PROCEDURE

surgery

minimally invasive transhiatal approach including a one-field node dissection or transthoracic approach with a two-field lymph node dissection

Sponsors & Collaborators

  • Threshold Pharmaceuticals

    collaborator INDUSTRY

  • Zuyderland Medical Centre

    collaborator OTHER

  • Maastricht Radiation Oncology

    lead OTHER

Principal Investigators

  • Philippe Lambin, MD, PhD · MUMC+, dept Radiotherapy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-04-30
Completion
2016-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02598687 on ClinicalTrials.gov