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Completed

NCT Number: NCT03600831

Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chinese Peiple's Liberation Army No.82 Hospital, Huai'an, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • biopsy-confirmed esophageal squamous cell carcinoma
  • age ≤ 70 years old,
  • Karnofsky performance status ≥ 70,
  • R0 esophagectomy according to the pathological examination of the resected specimens,
  • postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
  • Adequate organ functions (1).white blood cell (WBC) ≥3×109⁄L; (2).Absolute neutrophil counts (ANC) ≥1.5×109⁄L; (3).Hemoglobin (Hb) ≥10g⁄dl; (4).Platelet (Plt) ≥100×109⁄L; (5).Total bilirubin <1.5 upper limit of normal (ULN); (6).Aspartate transaminase (AST) ≤2.5 ULN; (7).Alanine aminotransferase (ALT) ≤2.5 ULN; (8).Creatinine ≤1.5 ULN; (9).adequate pulmonary function (FEV1>0.8 L;.
  • no previous treatment or severe complications
  • Written informed consent

Exclusion criteria

  • previous treatment with chemotherapy or radiotherapy
  • greater than 3 months after surgery
  • complete esophageal obstruction after surgery, esophageal perforation;
  • other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
  • pregnant or breast-feeding women;
  • patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease;
  • drug addiction, Alcoholism or AIDS;
  • uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  • with clear chemotherapy drug allergy
  • participation in other interventional clinical trials within 30 days;

Treatment and study plan

Docetaxel plus cisplatin

Drug

cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks

Radiotherapy

Radiation

radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

    From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。

Secondary outcomes

  1. Overall survival (OS)

    Time frame: From date of randomization to death from any cause, assessed up to 3 years

    From the date of randomization until the date of death

  2. treatment-related toxicities

    Time frame: From the date of randomization until six months after treatment completion

    Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0

  3. Quality of life(QOL)

    Time frame: 1 year

    Quality of life of patient will be evaluated using EORTC QLQ-C30. Evaluation of quality of life will be performed every 3 months.

Sponsors and collaborators

Lead sponsor

Huai'an First People's Hospital

Other

Collaborators

  • Chinese People's Liberation Army No. 82 Hospital
  • The Second People's Hospital of Huai'an
  • lian shui county People's Hospital
  • xuyi People's Hospital

Registry information

Official study title

A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Jul 26, 2018
Registry last updated
Jan 9, 2024

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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