Skip to main content
OpenTrials
Completed

NCT Number: NCT02607982

CCRT for Esophageal Cancer.

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

paclitaxel

Drug

PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.

Oxaliplatin

Drug

oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.

Radiotherapy

Radiation

Radiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used.

Primary outcomes

  1. response rate

    Time frame: week 4

    Response rate was done after 4 weeks following the last radiotherapy session.

Secondary outcomes

  1. Survival outcome

    Time frame: year 0- year 5

    Progression-free survival (PFS) was calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining. Overall survival (OS) was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.

  2. Toxicity

    Time frame: year 0- year 5

    Acute toxicities and late toxicities based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).

Sponsors and collaborators

Lead sponsor

Hangzhou Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2014
Study completion
2015
First posted
Nov 18, 2015
Registry last updated
Feb 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.