LOGIK1902

JRCT ID: jRCTs071200019

Registered date:29/06/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: non-small cell lung cancer
• Date of first enrollment: 29/09/2020
• Target sample size: 45
• Study type: Interventional
• Intervention(s): chemoradiation with use of weekly carboplatin and concurrent radiotherapy

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: Progression-free survival, overall survival, maintenance therapy shift rate, safety, response rate (no confirmation) during chemotherapy / concurrent chest radiotherapy

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with histologically or cytologically confirmed non-small cell lung cancer.
2)No prior history of chemotherapy, thoracic radiotherapy or surgical resection
3)Unresectable stage 3disease.
4)V20 is under 35%.
5)There is measurable region.
6)Age>=75
7)Eastern Cooperative Oncology Group performance status=<1
8)Leucocyte>=4000/mm3, Neutrocyte>=2000/mm3, platelets>=100000/mm3, hemoglobin>=9.0g/dl, AST and ALT=<100, bilirubin=<1.5mg/dl and serum creatinine=<1.5mg/dl. PaO2>=65torr or SpO2>=92%
9)Written informed consent.

Exclude criteria

1)Involvement of contralateral hilar lymph nodes.
2)Interstitial pneumonia or pulmonary fibrosis detected with chest X-ray.
3)SVC syndrome.
4)Obstructive pneumonia or active severe infection.
5)Other active invasive malignancies
6)Severe complications such as gastrointestinal bleeding, significant heart failure or uncontrolled diabetes and so on.
7)History of severe hypersensitivity.
8)Regular use of corticosteroids.
9)Mental illness
10)Pregnant woman and lactating woman
11)Active hepatitis B
12)A case considered by an investigator inadequate for the trial.

Related Information

• Primary Sponsor: Harada Taishi