Non-small cell lung cancer
Conditions
Interventions
None listed
Sponsors
North East Japan Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with NSCLC who were diagnosed with locoregional recurrence after surgical resection. (2)Patients undergoing complete resection (Pneumonectomy/bilobectomy/ lobectomy/segmentectomy) and radical resection with ND2a-1 or higher-level lymph node dissection. (3)Locoregional recurrence after complete surgical resection as recurrence only at the local site (the bronchial stump and adjacent areas) or also in the regional lymph node (ipsilateral hilar lymph nodes, mediastinal lymph nodes, and supraclavicular lymph nodes). Recurrence in the contralateral hilar lymph nodes and separate tumor nodule(s) in a different ipsilateral lobe were labeled as distant metastases and not included as locoregional recurrences. Postoperative recurrence was confirmed by one or both of computed tomography (CT) and 18F-fluorodeoxyglucose positron emission tomography-computed tomography (PET-CT). Histopathologic diagnosis (biopsy) is not required. (4) Patients with locoregional recurrences who had been treated for initial treatment by CRT containing platinum-based regimen followed by durvalumab (CRT-D group) or by CRT containing platinum-based regimen only (CRT group). Platinum-based chemotherapy must administered for at least 2 cycles. Patients must have received a total dose of radiation of 54 to 66 Gy. (5) Chemoradiotherapy must have been started between January 1, 2016 and December 31, 2020. (6) Patients who have not progressed following CRT in initial assessment. (7) In CRT group, patients must have received at least one dose of Durvalumab. (8) In CRT group, radiotherapy must have been completed by April 30, 2018. (9) Age of > 20 years at the start of CRT. (10)Patients for which survival and treatment information for postoperative recurrence information can be collected. (11)Patients who have not refused to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed as having small-cell lung cancer (SCLC), combined SCLC, large-cell neuroendocrine carcinoma. (2) In both groups, patients do not meet the eligibility criteria for Durvalumab (e.g. active autoimmune disease, grade 2 or higher pneumonitis from previous CRT) (3)Patients with distant metastases at diagnosis of recurrence or at initial evaluation after chemoradiotherapy. (4)Other cases that are determined to be inappropriate by attending physicians. (5)Patients with active multiple cancers. (6) Receipt of any investigational new drugs for post-treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS from the time of initiation of CRT. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year PFS rate and 2-year survival rate from the time of initiation of CRT. 2-year PFS rate and 2-year survival rate from the start date of durvalumab treatment. Objective Response rate (ORR) for CRT and Durvalumab. Safety during and after CRT. | — |
Countries
Japan
Contacts
Public ContactMegumi Furuta
Hokkaido University Graduate school of Medicine Department of Respiratory Medicine, Faculty of Medicine
Outcome results
None listed