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

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China (Other)

Overall Status

Recruiting

CT.gov ID

NCT03351842

Collaborator

(none)

460

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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%.

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

Study Type:

Interventional

Anticipated 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 :

Sep 1, 2017

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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

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

Primary Outcome Measures

Disease-Free-Survival-Rate [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

Overall-Survival-Rate [up to 60 months]
the percentage of people in the trial who alive, with or without signs of cancer
Disease-Free-Survival-Time [up to 60 months]
From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first
Overall-Survival-Time [up to 60 months]
Time from randomization until death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.