previously untreated non-small-cell lung ccancer, stage III (N2 positive)
Conditions
Interventions
Group A: Chemoradiotherapy consiting of Cisplatin and Docetaxel before surgery. Surgical resection is performed within 4 to 8 weeks after chemoradiotherapy is completed. After that, within 4 to 8 week
Sponsors
Okayama Lung Cancer Study Group (OLCSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) A case of non-small-cell lung cancer who proved pathologically (by histology or cytology). and seemed to be completely resectable. (2) Age is over 20 years old and under 75 years old. (3) A case of the first treatment. (4) A case of stage III whose metastasis to ipsilateral mediastinum and / or tracheal bifurcation lymph nodes was proved by longitudinal mediastinoscope or ultrasonic bronchoscope guided needle biopsy (EBUS - TBNA) etc. However, no pathological proof is required for #5 and 6 lymph nodes, if PET-CT is positive. The stage is evaluated by CT, MRI, PET-CT, etc. (5) A case whose ECOG Performance status (PS) is 0 - 1. (6) A case in which a three-dimensional radiation treatment plan is performed before registration and the treatment plan that V20 is 35% or less and radiation therapists comply with this protocol radiation treatment regulation is possible. (7) No case of other primary cancers within the past 5 years, and no active double cancer. (8) A Case with measurable lesions based on RECIST v 1.1. (9) A Case whose major organ function satisfies all of the following. White blood cell count > 4,000 / mm3, neutrophil count > 2,000 / mm3 Platelet count > 10,000 / mm3 Hemoglobin > 10.0 g / dL Serum AST and ALT: 2.5 times or less the upper limit of reference value of each facility Serum total bilirubin: 1.5 times or less the upper limit of reference value of each facility Serum creatinine < 1.5 mg / dL, CCr > 60 ml / min SpO2 > 92% in in room air (if SpO2 <92%, it is eligible if PaO2 > 70 Torr) forced expiratory volume in one second > 1.5 L / min (10) A case without any other serious complications, other physicians, surgeons and radiologists have agreed to implement the protocol. (11) A case judged to be able to survive for 3 months or more from the date of registration. (12) A case in which the subject consent has been obtained from the subject himself / herself.
Exclusion criteria
Exclusion criteria: (1) A case who has active double cancer. Even in case of metachronous double cancer (more than 5 years), patient with a history of chemotherapy or chest radiotherapy is excluded. (2) A case with severe drug allergy history. (3) Pregnant / lactating woman, a woman with an intention of pregnancy, a man with a partner who has an intention of pregnancy. (4) A case with severe complications such as the following. Active interstitial lung disease in chest X ray and CT Serious heart disease (difficult to control angina, myocardial infarction within 3 months, etc.) Diabetes mellitus difficult to control Serious infection Active hepatitis B, hepatitis C Other complications that are thought to have serious obstacles to the performance of treatment (5) A case with peripheral sensory neuropathy or peripheral motor neuropathy of more than grade 2. (6) A case that the doctor judged inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of preoperative treatment, progression-free survival, 2-year survival rate, overall survival time, curative resection rate of surgery, completion rate of protocol treatment , adverse event | — |
Countries
Japan
Contacts
Public ContactToshio Kubo
Okayama University Hospital Center for oncology
Outcome results
None listed