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

Sponsor

Fujian Medical University Union Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04009265

Collaborator

(none)

819

Enrollment

Location

Arms

94.3

Anticipated Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Combination Product: adjuvant treatment	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

819 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 23, 2019

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Overall Survival [3-year overall survival]
overall survival rate of each arms
Overall Survival [5-year overall survival]
overall survival rate of each arms

Secondary Outcome Measures

Disease Free Survival [3-year disease free survival]
Disease free survival rate of each arms
Disease Free Survival [5-year disease free survival]
Disease free survival rate of each arms
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.