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

A PHASE II STUDY Of ADJUVANT CHEMOTHERAPY After SURGERY For STAGE I Lung ADENOCARCINOMA PATIENTS With MICROPAPILLARY COMPONENT More Than Or EQUAL To 20%

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%.

Study Overview

• Status: Recruiting
• Conditions: Treatment; Histological Type of Neoplasm; Lung Adenocarcinoma, Stage I; Chemotherapy, Adjuvant
• Intervention / Treatment: Procedure: Undergo surgery; Drug: cis Platinum/Carboplatin, Pemetrexed Disodium

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 Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yingran Shen, PhD; Phone Number: 86-18117166317; Email: elaineshen91@gmail.com

Study Locations

• China
  • Shanghai, China, 200000
    • Recruiting
    • Thoracic Surgery Department of Shanghai Pulmonary Hospital
    • Contact: Yingran Shen; Phone Number: 86-18117166317; Email: elaineshen91@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Procedure: Undergo surgery; Therapeutic conventional surgery, R0 resection; 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: Paraplatin; ALIMTA; Cisplatin; Pemetrexed Disodium for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall-Survival-Rate	the percentage of people in the trial who alive, with or without signs of cancer	up to 60 months
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
Overall-Survival-Time	Time from randomization until death from any cause	up to 60 months

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 17, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Adjuvant chemotherapy; Early stage lung cancer; Micropapillary Component
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Neoplasms by Histologic Type; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Carboplatin; Cisplatin; Pemetrexed
• Other Study ID Numbers: K17-151

Drug and device information, study documents

• 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