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

Treatment Clinical Trial

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%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03351842
• Other study ID #: K17-151
• Status: Recruiting
• Phase: Phase 2
• First received: November 20, 2017
• Last updated: December 17, 2017
• Start date: September 1, 2017
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2017
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Yingran Shen, PhD
• Phone: 86-18117166317
• Email: elaineshen91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Chemotherapy, Adjuvant
• Histological Type of Neoplasm
• Lung Adenocarcinoma, Stage I
• Lung Neoplasms
• Neoplasms by Histologic Type
• Treatment

Intervention

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

Locations

Country	Name	City	State
China	Thoracic Surgery Department of Shanghai Pulmonary Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free-Survival-Rate	the percentage of people in the trial who are alive and cancer free after a specified number of years	up to 60 months
Secondary	Overall-Survival-Rate	the percentage of people in the trial who alive, with or without signs of cancer	up to 60 months
Secondary	Disease-Free-Survival-Time	From date of diagnosis until the date of first documented progression or date of cancer related death , whichever came first	up to 60 months
Secondary	Overall-Survival-Time	Time from randomization until death from any cause	up to 60 months