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Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%

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ClinicalTrials.gov Identifier: NCT03351842
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Gening Jiang, Shanghai Pulmonary Hospital, Shanghai, China

Study Description
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Brief 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%.

Condition or disease Intervention/treatment Phase
Chemotherapy, Adjuvant Lung Adenocarcinoma, Stage I Treatment Histological Type of Neoplasm Drug: cis Platinum/Carboplatin, Pemetrexed Disodium Procedure: Undergo surgery Phase 2

Detailed Description:

The presence of micropapillary component in adenocarcinoma is a predictor of poor prognosis, and has been reported to be to be chemosensitive to platinum-based chemotherapy. Seeking a more appropriate treatment for these patients, we perform this randomized phase II clinical trial. About 460 stage I lung adenocarcinoma patients with micropapillary component ≥ 20% will be included and divided into two group. Patients in the control group will only undergo complete R0 resection of the lesion, no further therapy will be used. While patients in the experimental group are going to receive platinum-based chemotherapy (comprising cisplatin and pemetrexed disodium)about 1 month after therapeutic surgery. Treatment continues every 3 weeks for 4 courses. Clinic and telephone follow up will be conducted for survival data monitoring.

DFS(disease free survival rate) and OS(overall survival rate) curves will be calculated using the Kaplan-Meier, life-table method. Comparison of the survival curve for the two groups will be performed using the log-rank test.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I
Undergo surgery, followed by observation. Patients receive no further therapy
 Procedure: Undergo surgery
Therapeutic conventional surgery, R0 resection
Experimental: Arm II
Undergo surgery, followed by chemotherapy (cis Platinum/Carboplatin, Pemetrexed Disodium). Patients receive chemotherapy comprising cisplatin 75mg/m2 or Carboplatin AUC=5mg/ml/min, and pemetrexed 500mg/m2 in day 1. Treatment continues every 3 weeks for 4 courses.
 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
Other Names:
  • Pemetrexed Disodium for Injection
  • ALIMTA
  • Cisplatin
  • Paraplatin

Procedure: Undergo surgery
Therapeutic conventional surgery, R0 resection


Outcome Measures
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Primary Outcome Measures :
  1. Disease-Free-Survival-Rate [ Time Frame: up to 60 months ]
    the percentage of people in the trial who are alive and cancer free after a specified number of years


Secondary Outcome Measures :
  1. Overall-Survival-Rate [ Time Frame: up to 60 months ]
    the percentage of people in the trial who alive, with or without signs of cancer

  2. Disease-Free-Survival-Time [ Time Frame: up to 60 months ]
    From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first

  3. Overall-Survival-Time [ Time Frame: up to 60 months ]
    Time from randomization until death from any cause


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completely resected Stage I NSCLC as defined by the International Staging System
  • Pathologically diagnosed Stage I micropapillary predominant lung adenocarcinoma
  • Patients must be randomized within 4 weeks from the date of surgery
  • No prior chemotherapy or radiation for non-small cell lung cancer
  • Performance status of 0 or 1
  • Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
  • Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has been disease free for five years
  • Granulocytes >= 1,800/ul
  • Platelets >= 100,000/ul
  • Bilirubin < 1.5 mg/dl
  • SGOT(serum glutamic-oxaloacetic transaminase) (AST) < 2.0 x ULN(upper limit of normal value)

Exclusion Criteria:

  • Do not meet the inclusion criteria
  • There is evidence of distant metastases
  • Suffered from other malignancies in five years
  • Within the past January subjects received other drug trials
  • Having serious allergies or idiosyncratic persons, such as you can not use folic acid, dexamethasone, vitamin B12 patients
  • Severe lung or heart disease, a history
  • Refuses or is unable to sign informed consent to participate in trials
  • The abuse of drugs or alcohol addicts.
  • Patients with difficult to control bacterial, viral, fungal infections
  • Having a personality or mental disorders, without civil capacity or restricted civil capacity.
  • Being pregnant or lactating women.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351842


Contacts
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Contact: Yingran Shen, PhD 86-18117166317 elaineshen91@gmail.com

Locations
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China
Thoracic Surgery Department of Shanghai Pulmonary Hospital Recruiting
Shanghai, China, 200000
Contact: Yingran Shen    86-18117166317    elaineshen91@gmail.com   
Sponsors and Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
More Information
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Responsible Party: Gening Jiang, Head of thoracic surgery, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials.gov Identifier: NCT03351842    
Other Study ID Numbers: K17-151
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Gening Jiang, Shanghai Pulmonary Hospital, Shanghai, China:
Adjuvant chemotherapy
Micropapillary Component
Early stage lung cancer
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Neoplasms by Histologic Type
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors