Pemetrexed and Platinum Use in the Neoadjuvant Setting for Resectable Stage II and IIIA Lung Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT02980991|
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : December 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Adenocarcinoma||Drug: Pemetrexed Drug: Cisplatin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pemetrexed and Platinum Use in the Neoadjuvant Setting for Resectable Stage II and IIIA Lung Adenocarcinoma|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: Neoadjuvant chemotherapy group
Two cycles of pemetrexed and cisplatin given to patients before surgery
Two cycles of pemetrexed 500mg/m2 day 1, 21 days per cycle for patients before surgery
Other Name: Neoadjuvant chemotherapy
Two cycles of cisplatin 75mg/m2 day 1 (or 25mg/m2 day 1-3), 21 days per cycle for patients before surgery
Other Name: Neoadjuvant chemotherapy
- radiological response rate [ Time Frame: Three to four weeks after the second cycle of neoadjuvant chemotherapy ]Three to four weeks after the first cycle of neoadjuvant chemotherapy, the same radiological examination as baseline chest CT or PET/CT scans are repeated for tumor response evaluation. Radiographic response was recorded by RECIST 1.1.
- Number of Adverse Events of chemotherapy [ Time Frame: ten months after neoadjuvant chemotherapy ]1) death due to cancer, toxicity or comorbidity,and 2) 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02980991
|Contact: Haiquan Chen, M.D, PH.Demail@example.com|
|Contact: Ting Ye, M.D.||+firstname.lastname@example.org|
|Fudan University Shanghai Cancer Center||Recruiting|
|Shanghai, China, 200032|
|Contact: Haiquan Chen, MD +86-21 64175590 ext 1707 email@example.com|
|Contact: Xinghua Cheng, MD,PhD +8618017317567 firstname.lastname@example.org|
|Principal Investigator: Haiquan Chen, MD|
|Study Chair:||Haiquan Chen, M.D, PH.D||Fudan University|