NCT02498860

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2018

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

2.4 years

First QC Date

July 13, 2015

Last Update Submit

August 1, 2021

Conditions

AdenocarcinomaLung Neoplasm

Keywords

adenocarcinomalungadjuvant chemotherapypemetrexedcisplatinsurgery

Outcome Measures

Primary Outcomes (1)

  • Disease free survival rate

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

    2 year

Secondary Outcomes (2)

  • Overall survival

    4 year

  • Adverse events

    4 months

Study Arms (1)

Pemebit plus Cisplatin

EXPERIMENTAL

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

Drug: PemebitDrug: Cisplatin

Interventions

PemebitDRUG

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

Also known as: Pemetrexed
Pemebit plus Cisplatin
CisplatinDRUG

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

Pemebit plus Cisplatin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 519-763, South Korea

Location

Kyungpook National University Medical Center

Daegu, Kyungpook, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Pusan National University Hospital

Pusan, 602-739, South Korea

Location

Kosin University Gospel Hospital

Pusan, South Korea

Location

Korea university Guro hospital

Seoul, South Korea

Location

Severance hospital

Seoul, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 23161898RESULT

  • 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.

    PMID: 16945766RESULT

  • 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.

    PMID: 16957145RESULT

  • 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.

    PMID: 36090637DERIVED

MeSH Terms

Conditions

AdenocarcinomaLung Neoplasms

Interventions

PemetrexedCisplatin

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Young-Chul Kim, MD, PhD

    Chonnam National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 15, 2015

Study Start

September 1, 2015

Primary Completion

February 6, 2018

Study Completion

July 31, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

KR(7)