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Completed

NCT Number: NCT02498860

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

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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Key information

Conditions

Adenocarcinoma Carcinoma Lung Diseases Lung Neoplasm Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chonnam National University Hwasun Hospital, Hwasun, Jeollanam-do, South Korea

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About this study

Primary endpoint : 2 year disease free survival

Secondary endpoints:

Overall survival, Frequency and severity of adverse events

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pemebit

Drug

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

Other names: Pemetrexed

Cisplatin

Drug

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

Primary outcomes

  1. Disease free survival rate

    Time frame: 2 year

    Disease free survival time is measured from the date of enrollment to date of tumor recurrence.

Secondary outcomes

  1. 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.

  2. Adverse events

    Time frame: 4 months

    adverse events using common terminology criteria for adverse events 4.0

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: APICAL

Important dates

Study start
2015
Primary completion
2018
Study completion
2021
First posted
Jul 15, 2015
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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