Long-term Results of Definitive Concurrent Chemoradiotherapy Using Paclitaxel Plus Oxaliplatin in Unresectable Locally Advanced Esophageal Cancer.

Hangzhou Cancer Hospital0 sites34 target enrollmentJanuary 2005

Overview

Brief Summary

This study aimed at assessing the efficiency and safety of concurrent chemoradiotherapy (CCRT) using paclitaxel (PTX) plus oxaliplatin (OHP) in unresectable locally advanced esophageal cancer patients.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hangzhou Cancer Hospital

Responsible Party

Principal Investigator

Shixiu Wu

MD

Hangzhou Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•Cytologically or histologically confirmed esophageal carcinoma
•Age of 20 -80
•ECOG performance status: 0-1;
•No treatments prior to enrollment;
•At least one measurable lesion on CT, MRI or esophageal barium exam;
•Normal functions of heart, lung, liver, kidney and bone marrow
•Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL
•Informed consent signed

Exclusion Criteria

•Prior treatments of chemotherapy or irradiation;
•Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
•Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
•Participating in other clinical trials;
•Pregnancy, breast feeding, or not adopting birth control;
•Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
•The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;

Arms & Interventions

Concurrent Chemoradiotherapy Arm

Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.

Intervention: Paclitaxel

Concurrent Chemoradiotherapy Arm

Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.

Intervention: Oxaliplatin

Concurrent Chemoradiotherapy Arm

Radiotherapy was delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks. Concurrent paclitaxel (135mg/m², d1) and oxaliplatin (125mg/ m², d1) were administered on Days 1 and Day 29 of radiotherapy.

Intervention: Radiotherapy