Study Compare Adjuvant Chemotherapy Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma

  • STATUS
    Recruiting
  • End date
    Jul 1, 2027
  • participants needed
    819
  • sponsor
    Fujian Medical University Union Hospital
Updated on 20 November 2021
cancer
carcinoma
squamous cell carcinoma
chemoradiotherapy
esophageal cancer
chemotherapy regimen
esophageal carcinoma
antineoplastic
esophagus cancer

Summary

A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.

Description

A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.

Details
Condition Esophageal Cancer, Squamous Cell Carcinoma of Esophagus, Squamous cell carcinoma, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma
Treatment adjuvant treatment
Clinical Study IdentifierNCT04009265
SponsorFujian Medical University Union Hospital
Last Modified on20 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants volunteer to participate the study and signed the informed consent
Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma
No antineoplastic treatments before operation
According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer
WHO PS score: 0-1
Age and gender: 18-75 years old, male and female unlimited
Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements

Exclusion Criteria

The surgical approach is left thoracic approach
Patients with severe postoperative complications who cannot receive adjuvant therapy
Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer
Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment
Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency
Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response
Known or suspected allergy to chemotherapeutic drugs
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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