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

Adenocarcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498860
• Other study ID #: CNUHH-2015-7
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2015
• Est. completion date: July 31, 2021

Study information

• Verified date: August 2021
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary endpoint : 2 year disease free survival

Secondary endpoints:

Overall survival, Frequency and severity of adverse events

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 31, 2021
• Est. primary completion date: February 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Lung Neoplasm
• Lung Neoplasms

Intervention

Drug:
• Pemebit
500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
• Cisplatin
75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Medical Center	Daegu	Kyungpook
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeonnam
Korea, Republic of	Kosin University Gospel Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Korea university Guro hospital	Seoul
Korea, Republic of	Severance hospital	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Chungnam National University Hospital, Korea University Guro Hospital, Kosin University Gospel Hospital, Kyungpook National University Hospital, Pusan National University Hospital, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Douillard JY, Rosell R, De Lena M, Carpagnano F, Ramlau R, Gonzáles-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, Hu — View 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 — View Citation

Olaussen KA, Dunant A, Fouret P, Brambilla E, André 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 an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival rate	Disease free survival time is measured from the date of enrollment to date of tumor recurrence.	2 year
Secondary	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.	4 year
Secondary	Adverse events	adverse events using common terminology criteria for adverse events 4.0	4 months