Clinical trial NCT02498860: Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adenocarcinoma
Lung Neoplasm
Keywords: adenocarcinoma
lung
adjuvant chemotherapy
pemetrexed
cisplatin
surgery
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Kosin University Gospel Hospital
name: Korea University Guro Hospital
name: Severance Hospital
name: Chungnam National University Hospital
name: Kyungpook National University Hospital
name: Pusan National University Hospital
First posted: 2015-07-15
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Disease free survival rate
timeFrame: 2 year
Secondary outcomes:
measure: Overall survival
timeFrame: 4 year
measure: Adverse events
timeFrame: 4 months
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
state: Kyungpook
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Seoul
country: Korea, Republic of
facility: Korea university Guro hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Young-Chul Kim, MD, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
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.