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OpenTrials
Completed

NCT Number: NCT02916511

Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma

The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for 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

  • Joined the study voluntarily and signed informed consent form;
  • Age 18-75;
  • ECOG 0-2;
  • Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
  • The operative incision healed well;
  • T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
  • No radiotherapy, chemotherapy or other treatments pre (post) surgery;
  • PS ECOG 0-2;
  • Life expectancy of more than 3 months;
  • Hemoglobin (Hb) ≥ 9 g/dL • WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L • platelet count (Pt) ≥ 100 x 109/L • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL< 1.5 x ULN • Renal function: creatinine < 1.5 x ULN
  • No immuno-deficiency;
  • Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion criteria

  • Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
  • Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
  • Participation in other interventional clinical trials within 30 days;
  • Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
  • Drug addiction, Alcoholism or AIDS;
  • Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  • Unsuitable to be enrolled in the trial in the opinion of the investigators.

Treatment and study plan

paclitaxel

Drug

paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5

carboplatin

Drug

carboplatin AUC=2, ivgtt, d1, qw*5

Radiotherapy

Radiation

1.8Gy/d, d1-5/week, 25Fx

Primary outcomes

  1. Local control rate

    Time frame: 2 years

Secondary outcomes

  1. overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Acronym: ESO-Shanghai9

Important dates

Study start
2016
Primary completion
2021
Study completion
2023
First posted
Sep 27, 2016
Registry last updated
Dec 22, 2023

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.