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

Primary Purpose

Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I, Treatment

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cis Platinum/Carboplatin, Pemetrexed Disodium
Undergo surgery
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy, Adjuvant focused on measuring Adjuvant chemotherapy, Micropapillary Component, Early stage lung cancer

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Thoracic Surgery Department of Shanghai Pulmonary HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

Undergo surgery, followed by observation. Patients receive no further therapy

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.

Outcomes

Primary Outcome Measures

Disease-Free-Survival-Rate
the percentage of people in the trial who are alive and cancer free after a specified number of years

Secondary Outcome Measures

Overall-Survival-Rate
the percentage of people in the trial who alive, with or without signs of cancer
Disease-Free-Survival-Time
From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first
Overall-Survival-Time
Time from randomization until death from any cause

Full Information

First Posted
November 20, 2017
Last Updated
December 17, 2017
Sponsor
Shanghai Pulmonary Hospital, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT03351842
Brief Title
Surgery With or Without Chemotherapy for Stage I NSCLC With Micropapillary Component ≥ 20%
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%
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

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

5. Study Description

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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy, Adjuvant, Lung Adenocarcinoma, Stage I, Treatment, Histological Type of Neoplasm
Keywords
Adjuvant chemotherapy, Micropapillary Component, Early stage lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Undergo surgery, followed by observation. Patients receive no further therapy
Arm Title
Arm II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cis Platinum/Carboplatin, Pemetrexed Disodium
Other Intervention Name(s)
Pemetrexed Disodium for Injection, ALIMTA, Cisplatin, Paraplatin
Intervention Description
Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
Intervention Type
Procedure
Intervention Name(s)
Undergo surgery
Intervention Description
Therapeutic conventional surgery, R0 resection
Primary Outcome Measure Information:
Title
Disease-Free-Survival-Rate
Description
the percentage of people in the trial who are alive and cancer free after a specified number of years
Time Frame
up to 60 months
Secondary Outcome Measure Information:
Title
Overall-Survival-Rate
Description
the percentage of people in the trial who alive, with or without signs of cancer
Time Frame
up to 60 months
Title
Disease-Free-Survival-Time
Description
From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first
Time Frame
up to 60 months
Title
Overall-Survival-Time
Description
Time from randomization until death from any cause
Time Frame
up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingran Shen, PhD
Phone
86-18117166317
Email
elaineshen91@gmail.com
Facility Information:
Facility Name
Thoracic Surgery Department of Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingran Shen
Phone
86-18117166317
Email
elaineshen91@gmail.com

12. IPD Sharing Statement

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

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