Pemetrexed and Platinum Use in the Neoadjuvant Setting for Resectable Stage II and IIIA Lung Adenocarcinoma (ECTOP-1002)
Condition: Lung Adenocarcinoma
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered
      as ECTOP-1002. The study is a prospective, single-center, open-label, single-armed, phase II
      clinical trial. The aim of the study is to evaluate the radiological response rate (RR) of 2
      cycles of neoadjuvant chemotherapy with pemetrexed and cisplatin in patients with resectable
      stage II and IIIA lung adenocarcinoma.
    

Detailed description: 
      The study is a prospective, single-center, open-label, single-armed, phase II clinical trial.
      Clinical staging is determined according to the routine protocol, which include enhanced
      chest CT scans, brain MRI or CT, bone scintigraphy, abdominal ultrasonography and
      cardiopulmonary tests. PET/CT scan was optional. Preoperative diagnoses of lymph node
      metastasis were performed using enhanced chest CT or PET/CT. Preoperative pathological
      diagnosis is confirmed by electronic fiber bronchoscopic biopsy, CT-guided percutaneous lung
      puncture biopsy and endobronchial ultrasonography （EBUS/EUS） when necessary.

      Patients are going to receive two cycles of pemetrexed 500mg/m2 day 1 and cisplatin 75mg/m2
      day 1 (or 25mg/m2 day 1-3), 21 days per cycle. Treatment cycles are repeated every 21 days.
      Following two cycles of chemotherapy, the same radiological examination as baseline chest CT
      or PET/CT scans are repeated for tumor response evaluation. Radiographic response was
      recorded by Response Evaluation Criteria in Solid Tumors （RECIST 1.1）. Patients undergo
      complete resection between 2 and 6weeks following the last dose of chemotherapy. The surgical
      extents left to the discretion of the general thoracic surgeon. And lobectomy and
      pneumonectomy with mediastinal lymph node dissection are recommended. Two cycles of
      post-surgery pemetrexed/cisplatin treatment will be administrated subsequently.

      The primary objective is to determine the radiological response rate (RR) of 2 cycles of
      neoadjuvant chemotherapy with pemetrexed and cisplatin in patients with resectable stage II
      and IIIA lung adenocarcinoma. The radiological response rate is measured 3 to 4 weeks after
      the second cycle of chemotherapy according to the RECIST criteria 1.1.

      The secondary objectives are to determine the pathological response rate, safety, the
      clinical feasibility rate, the drug delivery, 2-year disease free survival (DFS) and 2-year
      overall survival (OS).The pathological response rate is investigated by determination of the
      type and extent of vital tumor tissue and tumor necroses as well as reactive alterations with
      foam cell reaction and fibrosis or scar formation on light microscopic evaluation of surgical
      resection specimens stained with H&E.The clinical feasibility is achieved if 1) no death due
      to cancer, toxicity or comorbidity,and 2) no toxicity events including Grade 4 neutropenia >7
      days; febrile grade 3/4 neutropenia; grade 4 thrombocytopenia >7 days or any grade with
      bleeding; grade 3/4 nonhematologic toxicity related to chemotherapy (except
      nausea/vomiting/hair loss) are observed. The drug delivery is defined as the accomplishment
      of the chemotherapy.DFS is measured from the date of operation until the date of first
      progression or recurrence. OS is measured from the date of operation until the date of death
      from NSCLC or the date last seen alive.
    

Intervention name(s): Pemetrexed; Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Two cycles of pemetrexed 500mg/m2 day 1, 21 days per cycle for patients before surgery; Two cycles of cisplatin 75mg/m2 day 1 (or 25mg/m2 day 1-3), 21 days per cycle for patients before surgery
Other intervention name(s): Neoadjuvant chemotherapy; Neoadjuvant chemotherapy
Intervention MeSH terms: Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment