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OpenTrials
Completed

NCT Number: NCT02459457

A Comparison of Paclitaxel-based Three Regimens Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Cancer

The purpose of this study is to determined the best scheme in paclitaxel and cisplatin,paclitaxel and fluorouracil,paclitaxel and carboplatin concurrent with radiotherapy for patients with local advanced esophageal Squamous Cell Carcinoma.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

To be eligible for this study, patient must fulfill all of the following criteria:

  • Histologically confirmed esophageal squamous cell carcinoma
  • Clinical stages II, III or IVa based on the 6th UICC-TNM classification
  • No prior treatment of chemotherapy, radiotherapy or surgery against esophageal cancer, except for non-curative resection by EMR/ESD.
  • Aged 18-75 years
  • Adequate organ functions
  • White blood cell (WBC) ≥3×109⁄L
  • Absolute neutrophil counts (ANC) ≥1.5×109⁄L
  • Hemoglobin (Hb) ≥10g⁄dl
  • Platelet (Plt) ≥100×109⁄L
  • Total bilirubin <1.5 upper limit of normal (ULN)
  • Aspartate transaminase (AST) ≤2.5 ULN
  • Alanine aminotransferase (ALT) ≤2.5 ULN
  • Creatinine ≤1.5 ULN
  • ECOG PS of 0-2
  • Life expectancy ≥3 months
  • Written informed consent

Exclusion criteria

Patients fulfilling any of the following criteria are ineligible for this study.

  • Esophageal perforation or hematemesis
  • Synchronous or metachronous malignancies (except for cutaneous (non-melanomas) carcinoma, thyroid papillary carcinoma, phase I seminoma or cervical carcinoma in situ curatively treated and disease free for a minimum of 3 months)
  • Received thoracic, abdominal or craniocerebral surgery within 30 days
  • Enrolled in other clinical trials within 30 days
  • Unstable angina and/or congestive heart failure requiring hospitalization within 6 months
  • Severe psychiatric disease
  • Pregnancy, lactation or unwillingness to adopt contraception
  • Drug addiction
  • Acquired immune deficiency syndrome (AIDS) based upon current CDC definition
  • Patients with hearing impairment or sensory-motor neuropathy of WHO grade > 1
  • History of radiotherapy in the planning area
  • Other ineligible conditions according to researchers

Treatment and study plan

Paclitaxel and cisplatin

Drug

patients get Paclitaxel and Cisplatin according to protocol

Other names: TP

Paclitaxel and Fluorouracil

Drug

patients get Paclitaxel and Fluorouracil according to protocol

Other names: TF

Paclitaxel and Carboplatin

Drug

patients get Paclitaxel and Carboplatin according to protocol

Other names: TC

Radiotherapy

Radiation

1.8Gy/d, d1-5/week, 34Fx

Primary outcomes

  1. overall survival

    Time frame: 3 years

Secondary outcomes

  1. progression free survival

    Time frame: 1year, 2 years, 3 years

  2. adverse event

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Collaborators

  • Gansu Cancer Hospital
  • Huadong Hospital
  • Jiangsu Cancer Institute & Hospital
  • Jiangxi Provincial Cancer Hospital
  • Shanxi Province Cancer Hospital
  • The First Affiliated Hospital of Xiamen University
  • Wuxi No. 4 People's Hospital

Registry information

Official study title

A Comparison of Paclitaxel in Combination With Cisplatin(TP), Carboplatin(TC) or Fluorouracil(TF) Concurrent With Radiotherapy for Patients With Local Advanced Esophageal Squamous Cell Carcinoma: A Three-Arm Randomized Phase III Trial

Important dates

Study start
2015
Primary completion
2020
Study completion
2022
First posted
Jun 2, 2015
Registry last updated
Feb 9, 2022

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.

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