Study of Docetaxel or Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Esophageal Cancer

  • STATUS
    Recruiting
  • End date
    Jul 24, 2023
  • participants needed
    610
  • sponsor
    Sun Yat-sen University
Updated on 24 January 2021
esophagectomy
cancer
carcinoma
ivor
chemoradiotherapy
esophageal cancer
docetaxel
esophageal carcinoma
cancer treatment
vinorelbine
blood count
blood cell count
esophagus cancer

Summary

The primary objective is to compare docetaxel plus cisplatin (DP) versus vinorelbine plus cisplatin (NP) in neoadjuvant chemoradiotherapy, in terms of the overall survival and toxicity in patients with Stage IIB or III squamous cell esophageal carcinoma.

Description

Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 456,000 new cases and 400,000 deaths occurred annually worldwide. Every year in China, no matter new cases or deaths account for more than half of the world. Besides, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).

Preoperative chemoradiotherapy (CRT) followed by surgery can hopefully improve the survival of ESCC. The CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increase the overall survival of patients with EC compared with surgery alone. The therapeutic effects were also found in 84 ESCC cases enrolled in this trial. Previously, the investigators performed a phase III, randomized clinical trial (NCT01216527) to compare the overall survival of stage IIB-III ESCC patients treated with or without neoadjuvant CRT, in which vinorelbine plus cisplatin was used as chemotherapy regime. The enrollment was completed in 2014. The outcomes will hopefully prove the survival benefit of neoadjuvant CRT to ESCC.

However, the investigators also observed that some patients suffer from the toxic response of neoadjuvant therapy, such as myelosuppression (45.2%), pulmonary toxicity (42.9%), and esophagitis (59.5%). The toxicity caused by CRT will decrease the patient compliance; moreover increase the perioperative complications and deaths, which may totally offset the survival benefit. Therefore, it is important to improve chemoradiotherapy effect and reduce toxicity, so as to achieve better survival in ESCC patients.

Docetaxel draws increasing attentions with its high effective rate and low toxicity. Several Phase II clinical trials and retrospective studies suggested that docetaxel showed better survival benefits in both monotherapy and combined-therapy in EC patients. Therefore, the investigators intended to conduct a phase III, randomized clinical trial to further explore whether docetaxel plus cisplatin would be an effective therapy with lower toxicity.

The investigators are to carry out a phased III clinical trial to compare the effect and toxicity of docetaxel plus cisplatin with vinorelbine plus cisplatin in neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma.

Details
Condition Esophageal Diseases, Esophageal Disorders, Esophageal Cancer, Esophageal Cancer, Squamous cell carcinoma, Squamous cell carcinoma, head and neck cancer, head and neck cancer, Esophageal Carcinoma, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Esophagus, Esophageal Disorders, esophagus cancer, oesophageal cancer, cancer of the esophagus, oesophageal carcinoma
Treatment cisplatin, docetaxel, Radiation, Surgery, Vinorelbine
Clinical Study IdentifierNCT02465736
SponsorSun Yat-sen University
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T4aN0M0, according to 7th edition of Union for International Cancer Control (UICC) staging system
Patients must not have received any prior anticancer therapy
More than 6 months of expected survival
Age ranges from 18 to 70 years
Absolute white blood cells count 4.0109/L, neutrophil 1.5109/L, platelets 100.0109/L, hemoglobin 90g/L, and normal functions of liver and kidney
WHO performance status (PS) of 0-1
Signed informed consent document on file

Exclusion Criteria

Patients have received any prior anticancer therapy
Patients with advanced inoperable or metastatic esophageal carcinoma
Patients with concomitant hemorrhagic disease
Patients with other uncontrollable status that cannot tolerate surgery
Pregnant or breast feeding
Patients cannot signed the informed consent document because of psychological quality, family and social factors
Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more
Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer
Have a history of diabetes over 10 years and with poorly controlled blood sugar level
patients with serious cardiac, respiratory, hepatic, renal, hematologic, immunological disease or cachexy, who cannot tolerate chemoradiotherapy or surgery
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