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

NCT04009265 | Recruiting Phase 3 DMC

• 1 other identifier: ACRTEC UNION
• Study Type: interventional
• Target: 819
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinoma; adjuvant chemotherapy; adjuvant chemoradiotherapy; surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Disease Free Survival

  3-year disease free survival

• Disease Free Survival

  5-year disease free survival

• Adverse Events

  1 year

• Scores of Quality of Life

  5 years

Study Arms (3)

Chemotherapy

EXPERIMENTAL

Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.

Combination Product: adjuvant treatment

Chemoradiotherapy

EXPERIMENTAL

5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles

Combination Product: adjuvant treatment

Surgery alone

NO INTERVENTION

Surgery alone, no adjuvant treatment.

Interventions

adjuvant treatment COMBINATION_PRODUCT

adjuvant treatments include chemotherapy or chemoradiotherapy

Chemoradiotherapy; Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Chun Chen, MD

  Fujian Medical University Union Hospital

  STUDY DIRECTOR

Central Study Contacts

Bin Zheng, MD

CONTACT

+8659186218408; lacustrian@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: August 23, 2019
• Primary Completion: July 1, 2022
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)