Clinical trial · Interventional

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

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

NCT02498860CI-TRIAL-00053146APICALcompletedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Adenocarcinoma	Adenocarcinoma	ONTOLOGY_EXACT	0.90
Lung Neoplasm	Lung Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Cisplatin	Drug	Cisplatin	ALIAS
Pemebit	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Pemebit plus Cisplatin
description
Pemetrexed (Pemebit 500 mg/m2) plus cisplatin (75 mg/m2) every 3 weeks up to 4 cycles
interventionNames
1. Drug: Pemebit
2. Drug: Cisplatin

Primary outcomes (1)

measure
Disease free survival rate
timeFrame
2 year
description
Disease free survival time is measured from the date of enrollment to date of tumor recurrence.

Secondary outcomes (2)

measure
Overall survival
timeFrame
4 year
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years

Show eligibility criteria text

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

References

Publications (4)

RESULTKreuter 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 23161898
RESULTDouillard 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 16945766
RESULTOlaussen 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 16957145
DERIVEDPark 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 36090637

Registry

Dates and enrollment

Start: Sep 1, 2015
Primary completion: Feb 6, 2018
Completion: Jul 31, 2021
First posted: Jul 15, 2015
Last update posted: Aug 6, 2021
Enrollment: 106 (actual)
Lead sponsor: Chonnam National University Hospital OTHER
Collaborators: Kosin University Gospel Hospital; Korea University Guro Hospital; Severance Hospital; Chungnam National University Hospital; Kyungpook National University Hospital; Pusan National University Hospital
Keywords: adenocarcinoma, lung, adjuvant chemotherapy, pemetrexed, cisplatin, surgery

Data updated 22 days agoSource updated Aug 6, 2021source: clinicaltrials

Locations

Locations by country (7)

Country	Sites	Recruiting
South Korea	7	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.