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Recruiting NCT04009265

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

Phase III Interventional Esophageal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: adjuvant treatment.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma

Overview

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.

Detailed 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.

Interventions

  • Combination product adjuvant treatment
    adjuvant treatments include chemotherapy or chemoradiotherapy

Primary outcome measures

  • Overall Survival [Time frame: 3-year overall survival]
  • Overall Survival [Time frame: 5-year overall survival]
Secondary outcome measures (4)
  • Disease Free Survival [Time frame: 3-year disease free survival]
  • Disease Free Survival [Time frame: 5-year disease free survival]
  • Adverse Events [Time frame: 1 year]
  • Scores of Quality of Life [Time frame: 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fujian Medical University Union Hospital — Fuzhou

Identifiers

NCT: NCT04009265 · ACRTEC UNION

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗