Status:
UNKNOWN
Adjuvant Chemotherapy for High Risk Stage I Lung Adenocarcinoma
Lead Sponsor:
Fudan University
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1004. Solid subtype, micropapillary subtype, vascular involvement, pleural involvement and low di...
Detailed Description
Background: Management of lung cancer varies according to the clinical and pathological stage. For stage I lung adenocarcinoma, radical surgery is the preferred initial treatment and adjuvant chemoth...
Eligibility Criteria
Inclusion
- Stage pI lung adenocarcinoma confirmed through formalin-fixed paraffin-embedded tumor tissue, complete resection with mediastinal lymph node dissection
- Meet one of following conditions: a, Solid predominant adenocarcinomas; b, micropapillary predominant adenocarcinoma; c, low differentiation, unable to identify histological subtypes; d, pleural involvement; e, vascular involvement with solid subtype component or micropapillary component.
- Aged 18-70 years old.
- Eastern Cooperative Oncology Group score standard (ECOG) status 0-1.
- Medical condition permits adjuvant chemotherapy.
- Patients accept the clinical trial protocol and Informed Consent Form (ICF) signed.
Exclusion
- Concurrent other malignancies
- Prior chemotherapy and/or radiation therapy for lung cancer
- Central type lung cancer
- Concurrent other unresected suspicious nodules or masses in lung
- Medical condition that will not permit treatment or follow up according to the protocol, or ECOG status \>1.
- Pregnant or nursing women.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03380468
Start Date
January 1 2018
End Date
December 31 2025
Last Update
July 20 2023
Active Locations (1)
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1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032