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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Combination product: adjuvant treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 819
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bin Zheng, MD; Phone Number: 8408 +8659186218408; Email: lacustrian@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Bin Zheng, MD; Phone Number: +8659186218408

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. The surgical approach is left thoracic approach;
2. Patients with severe postoperative complications who cannot receive adjuvant therapy;
3. 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.
4. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
5. 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;
6. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
7. Known or suspected allergy to chemotherapeutic drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chemotherapy; Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.	Combination product: adjuvant treatment; adjuvant treatments include chemotherapy or chemoradiotherapy
Experimental: Chemoradiotherapy; 5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles	Combination product: adjuvant treatment; adjuvant treatments include chemotherapy or chemoradiotherapy
No Intervention: Surgery alone; Surgery alone, no adjuvant treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	overall survival rate of each arms	3-year overall survival
Overall Survival	overall survival rate of each arms	5-year overall survival

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	Disease free survival rate of each arms	3-year disease free survival
Disease Free Survival	Disease free survival rate of each arms	5-year disease free survival
Adverse Events	Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE)	1 year
Scores of Quality of Life	Assess the quality of life based on EORTC QLQ-C30 and OES18	5 years

Collaborators and Investigators

• Sponsor: Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2027

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 10, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: surgery; adjuvant chemotherapy; esophageal squamous cell carcinoma; adjuvant chemoradiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: ACRTEC UNION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No