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

Phase 3

Recruiting

• Conditions: Esophageal Squamous Cell Carcinoma
• Interventions: Combination Product: adjuvant treatment

• Registration Number: NCT04009265
• Lead Sponsor: Fujian Medical University Union Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-05
• Study Start: 2019-08-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-10
• Last Update Posted: 2021-11-12
• Primary Completion: 2022-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 819

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy	adjuvant treatment	5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
Chemotherapy	adjuvant treatment	Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.

Primary Outcome Measures

Name	Time	Method
Overall Survival	5-year overall survival	overall survival rate of each arms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China