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

Chonnam National University

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasm; Adenocarcinoma

Treatments: Drug: Cisplatin; Drug: Pemebit

Study type: Interventional

Funder types: Other

Identifiers

NCT02498860

CNUHH-2015-7

Details and patient eligibility

About

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.

Full description

Primary endpoint : 2 year disease free survival

Secondary endpoints:

Overall survival, Frequency and severity of adverse events

Enrollment: 106 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Pemebit plus Cisplatin

Experimental group

Description:

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

Treatment:

Drug: Cisplatin

Drug: Pemebit