Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma
NCT ID: NCT04009265
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
819 participants
INTERVENTIONAL
2019-08-23
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy
Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.
adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
Chemoradiotherapy
5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
Surgery alone
Surgery alone, no adjuvant treatment.
No interventions assigned to this group
Interventions
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adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Responsible Party
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Principal Investigators
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Chun Chen, MD
Role: STUDY_DIRECTOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Bin Zheng, MD
Role: primary
Other Identifiers
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ACRTEC UNION
Identifier Type: -
Identifier Source: org_study_id