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

NCT03351842 | Recruiting Phase 2 FDA Drug

• 1 other identifier: K17-151
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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%.

Conditions

Chemotherapy, Adjuvant; Lung Adenocarcinoma, Stage I; Treatment; Histological Type of Neoplasm

Keywords

Adjuvant chemotherapy; Micropapillary Component; Early stage lung cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall-Survival-Rate

  up to 60 months

• Disease-Free-Survival-Time

  up to 60 months

• Overall-Survival-Time

  up to 60 months

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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

Procedure: Undergo surgery

Arm II

EXPERIMENTAL

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; Procedure: Undergo surgery

Interventions

cis Platinum/Carboplatin, Pemetrexed Disodium DRUG

Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours

Also known as: Pemetrexed Disodium for Injection, ALIMTA, Cisplatin, Paraplatin

Arm II

Undergo surgery PROCEDURE

Therapeutic conventional surgery, R0 resection

Arm I; Arm II

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Thoracic Surgery Department of Shanghai Pulmonary Hospital

Shanghai, 200000, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma of Lung; Neoplasms by Histologic Type

Interventions

Cisplatin; Carboplatin; Pemetrexed; Injections

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Yingran Shen, PhD

CONTACT

86-18117166317; elaineshen91@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of thoracic surgery

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2024
• Last Updated: December 19, 2017

Record last verified: 2017-12

Locations

CN (1)