Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
NCT03351842 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 460
Last updated 2017-12-19
Summary
Randomized phase II trial aims to compare surgery with or without adjuvant chemotherapy in treating patients who are pathologically diagnosed as stage I lung adenocarcinoma with micropapillary component no less than 20%.
Conditions
- Chemotherapy, Adjuvant
- Lung Adenocarcinoma, Stage I
- Treatment
- Histological Type of Neoplasm
Interventions
- DRUG
-
cis Platinum/Carboplatin, Pemetrexed Disodium
Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
- PROCEDURE
-
Undergo surgery
Therapeutic conventional surgery, R0 resection
Sponsors & Collaborators
-
Shanghai Pulmonary Hospital, Shanghai, China
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-01
- Primary Completion
- 2019-09-01
- Completion
- 2024-09-01
- FDA Drug
- Yes
Countries
- China
Study Locations
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