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

Esophageal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04009265
• Other study ID #: ACRTEC UNION
• Status: Recruiting
• Phase: Phase 3
• Start date: August 23, 2019
• Est. completion date: July 1, 2027

Study information

• Verified date: November 2021
• Source: Fujian Medical University Union Hospital
• Contact: Bin Zheng, MD
• Phone: +8659186218408
• Email: lacustrian[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 819
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Combination Product:
• adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

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