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

Primary Purpose

Adenocarcinoma, Lung Neoplasm

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pemebit
Cisplatin
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenocarcinoma focused on measuring adenocarcinoma, lung, adjuvant chemotherapy, pemetrexed, cisplatin, surgery

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonnam National University Hwasun Hospital
  • Kyungpook National University Medical Center
  • Chungnam National University Hospital
  • Pusan National University Hospital
  • Kosin University Gospel Hospital
  • Korea university Guro hospital
  • Severance hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemebit plus Cisplatin

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall survival
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.
Adverse events
adverse events using common terminology criteria for adverse events 4.0

Full Information

First Posted
July 13, 2015
Last Updated
August 1, 2021
Sponsor
Chonnam National University Hospital
Collaborators
Kosin University Gospel Hospital, Korea University Guro Hospital, Severance Hospital, Chungnam National University Hospital, Kyungpook National University Hospital, Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02498860
Brief Title
Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung
Acronym
APICAL
Official Title
Efficacy and Safety of Pemetrexed Plus Cisplatin as Combination Chemotherapy for Post-operative Adenocarcinoma : Multi-center, Single Arm, Open-label, Phase Ⅱ Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Kosin University Gospel Hospital, Korea University Guro Hospital, Severance Hospital, Chungnam National University Hospital, Kyungpook National University Hospital, Pusan National University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Primary endpoint : 2 year disease free survival Secondary endpoints: Overall survival, Frequency and severity of adverse events

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenocarcinoma, Lung Neoplasm
Keywords
adenocarcinoma, lung, adjuvant chemotherapy, pemetrexed, cisplatin, surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pemebit plus Cisplatin
Arm Type
Experimental
Arm Description
Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles
Intervention Type
Drug
Intervention Name(s)
Pemebit
Other Intervention Name(s)
Pemetrexed
Intervention Description
500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
Primary Outcome Measure Information:
Title
Disease free survival rate
Description
Disease free survival time is measured from the date of enrollment to date of tumor recurrence.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
4 year
Title
Adverse events
Description
adverse events using common terminology criteria for adverse events 4.0
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Chul Kim, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeonnam
ZIP/Postal Code
519-763
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
State/Province
Kyungpook
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Korea university Guro hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23161898
Citation
Kreuter M, Vansteenkiste J, Fischer JR, Eberhardt W, Zabeck H, Kollmeier J, Serke M, Frickhofen N, Reck M, Engel-Riedel W, Neumann S, Thomeer M, Schumann C, De Leyn P, Graeter T, Stamatis G, Zuna I, Griesinger F, Thomas M; TREAT investigators. Randomized phase 2 trial on refinement of early-stage NSCLC adjuvant chemotherapy with cisplatin and pemetrexed versus cisplatin and vinorelbine: the TREAT study. Ann Oncol. 2013 Apr;24(4):986-92. doi: 10.1093/annonc/mds578. Epub 2012 Nov 15.
Results Reference
result
PubMed Identifier
16945766
Citation
Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzales-Larriba JL, Grodzki T, Pereira JR, Le Groumellec A, Lorusso V, Clary C, Torres AJ, Dahabreh J, Souquet PJ, Astudillo J, Fournel P, Artal-Cortes A, Jassem J, Koubkova L, His P, Riggi M, Hurteloup P. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncol. 2006 Sep;7(9):719-27. doi: 10.1016/S1470-2045(06)70804-X. Erratum In: Lancet Oncol. 2006 Oct;7(10):797.
Results Reference
result
PubMed Identifier
16957145
Citation
Olaussen KA, Dunant A, Fouret P, Brambilla E, Andre F, Haddad V, Taranchon E, Filipits M, Pirker R, Popper HH, Stahel R, Sabatier L, Pignon JP, Tursz T, Le Chevalier T, Soria JC; IALT Bio Investigators. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med. 2006 Sep 7;355(10):983-91. doi: 10.1056/NEJMoa060570.
Results Reference
result
PubMed Identifier
36090637
Citation
Park CK, Oh HJ, Yoo SS, Lee SY, Lee SH, Kim EY, Lee SY, Choi J, Lee MK, Kim MH, Jang TW, Chung C, Oh IJ, Kim YC. Open-label, multi-center, phase II study of adjuvant pemetrexed plus cisplatin for completely resected stage IB to IIIA adenocarcinoma of the lung: APICAL trial. Transl Lung Cancer Res. 2022 Aug;11(8):1606-1618. doi: 10.21037/tlcr-22-183.
Results Reference
derived

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

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