Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2021-07-31

Brief Summary

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Two-Year Disease Free Survival Rate of Stage IB\~IIIA adenocarcinoma after Adjuvant Chemotherapy with Pemetrexed and Cisplatin will be assessed. A total of 106 patients will be recruited for 12 months, and followed for two years, thus the duration of study will be 36 months.

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Detailed Description

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Primary endpoint : 2 year disease free survival

Secondary endpoints:

Overall survival, Frequency and severity of adverse events

Conditions

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Adenocarcinoma Lung Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pemebit plus Cisplatin

Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles

Group Type EXPERIMENTAL

Pemebit

Intervention Type DRUG

500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

Cisplatin

Intervention Type DRUG

75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

Interventions

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Pemebit

500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

Intervention Type DRUG

Cisplatin

75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

Intervention Type DRUG

Other Intervention Names

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Pemetrexed

Eligibility Criteria

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Inclusion Criteria

* Adenocarcinoma of Lung
* Postoperative pathologic stage IB\~IIIA
* Complete surgical resection (R0 resection) N1-2: R0 resection with lobectomy and mediastinal lymph nodes dissection (MLND) N0: R0 resection with lobectomy with or without MLND
* Adjuvant treatment should start between 4 to 6 weeks after surgery
* ECOG performance status 0-1
* Weight loss during last 3 months should be less than 10%.
* Normal hematologic, hepatic and renal function Neutrophil count \> 1500 /microliter, Platelet \> 100,000/microliter, Hemoglobin \> 9 g/dL Bilirubin \<=1.5 x upper limit normal, transaminase \< 2.5 x upper limit normal Serum Creatinine \<=1.5 mg/dL
* Women in child bearing age should consent using contraceptive measures, and must have negative pregnancy test.

Exclusion Criteria

* Other malignant neoplastic disease within 5 years.
* Neoadjuvant chemotherapy before surgery of lung cancer
* Patients who will be treated with postoperative radiation.
* Stage IIIB or IV lung cancer
* Severe infection, or cardiorespiratory, hematologic illness
* HIV positive cases
* Pregnancy or lactating women
* Autoimmune diseases or those who receiving immune suppressive treatment
* Symptomatic neuropathy \> CTCAE grade 1
* Those who consented other clinical trials within 3 months
* Other significant medical conditions contraindicated to clinical trial

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No