Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung (APICAL)

August 1, 2021 updated by: Young-Chul Kim, Chonnam National University Hospital

Efficacy and Safety of Pemetrexed Plus Cisplatin as Combination Chemotherapy for Post-operative Adenocarcinoma : Multi-center, Single Arm, Open-label, Phase Ⅱ Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary endpoint : 2 year disease free survival

Secondary endpoints:

Overall survival, Frequency and severity of adverse events

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Pusan, Korea, Republic of, 602-739
        • Pusan National University Hospital
      • Pusan, Korea, Republic of
        • Kosin University Gospel Hospital
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
    • Jeonnam
      • Hwasun, Jeonnam, Korea, Republic of, 519-763
        • Chonnam National University Hwasun Hospital
    • Kyungpook
      • Daegu, Kyungpook, Korea, Republic of
        • Kyungpook National University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pemebit plus Cisplatin
Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles
Drug: Pemebit
500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
Other Names:
  • Pemetrexed
Drug: Cisplatin
75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival rate
Time Frame: 2 year
Disease free survival time is measured from the date of enrollment to date of tumor recurrence.
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 4 year
Overall survival time is measured from the date of enrollment to date of death from any cause. Participants who are alive when the data lock or is lost to follow-up will have their overall survival time censored on the last date the participant is known to be alive.
4 year
Adverse events
Time Frame: 4 months
adverse events using common terminology criteria for adverse events 4.0
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Collaborators

Pusan National University Hospital
Korea University Guro Hospital
Kyungpook National University Hospital
Severance Hospital
Chungnam National University Hospital
Kosin University Gospel Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

February 6, 2018

Study Completion (Actual)

July 31, 2021

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNUHH-2015-7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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