JCOG1914: A clinical trial for elderly patients with unresectable locally advanced non-small cell lung cancer

JRCT ID: jRCTs031200230

Registered date:04/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable locally advanced non-small cell lung cancer.
• Date of first enrollment: 16/12/2020
• Target sample size: 166
• Study type: Interventional

Intervention(s)

Arm A: Radiotherapy (60 Gy/30 fr, 5 days/week) with intravenous administration of CBDCA (30mg/m2, on the first 20 days of radiotherapy).
Arm B: Radiotherapy (60 Gy/30 fr, 5 days/week) with intravenous administration of CBDCA (AUC 2 (min*mg/mL), weekly, on the first day of radiotherapy) and nab-PTX (30mg/m2, weekly, on the first day of radiotherapy).

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Progression free survival, response rate, proportion of patients starting maintenance durvalumab therapy, proportion of patients with adverse events, proportion of patients with serious adverse events, location of progression, proportion of patients without FACT-TOI deterioration, proportion of patients without IADL deterioration.

Key inclusion & exclusion criteria

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

Include criteria

(1) Histologically or cytologically proven non-small cell lung cancer.
(2) Diagnosed as unresectable c-stage III and also fulfills at least one of the following conditions on imaging studies. (Excluding postoperative recurrence)
(i) N0-1 and presence of direct invasion into the parietal pleura, chest wall, phrenic nerve, or pericardium.
(ii) N0-1 and presence of direct invasion into the diaphragm, mediastinum, heart, great vessels, trachea, recurrent laryngeal nerve, esophagus, vertebral body, or carina, or separate tumor in different love of ipsilateral lung.
(iii) N2-3 with any T.
(iv) Judged unresectable by both an oncologist and a thoracic surgeon.
(3) Aged 75 years and older at the time of enrollment.
(4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
(5) IMRT or 3D-CRT according to the protocol is considered possible by a radiation oncologist.
(6)No previous chemotherapy and radiotherapy against the lung cancer
(7) If prior history of radiotherapy is present, the patient fulfills both of the following requirements.
(i) No past radiotherapy to the hilums of the lungs or the mediastinum.
(ii) No prior history of radiation pneumonitis of grade 2 or higher.
(8) Sufficient org an function. (Results of tests performed within 14 days prior to enrollment.)
(i) Neutrophil count >= 1,500/mm3
(ii) Hemoglobin >= 9.0 g/dL (transfusion within 14 days prior to the blood test is not allowed)
(iii) Platelet count >= 100,000 /mm3
(iv) Total bilirubin <= 1.5 mg/dL
(v) Asparate aminotransferase <= 100 U/L
(vi) Alanine aminotransferase <= 100 U/L
(vii) Creatinine <= 1.2 mg/dL
(viii) SpO2 >= 93%
(9) Written informed consent.

Exclude criteria

(1) History of synchronous or metachronous (within 2 years) malignancies with 5-year relative survivals of less than 95% at the time of diagnosis.)
(2) Active infection requiring systemic therapy.
(3) Fever with a body temperature higher than 38.0 degrees Celsius at the time of enrollment.
(4) Psychiatric illnesses or symptoms affecting daily lives.
(5) Systemic administration of steroids or immunosuppressive agents.
(6) Uncontrolled diabetes.
(7) Unstable angina (diagnosis or worsening of chest pain within 3 weeks); history of myocardial infarction within 6 months prior to enrollment; or uncontrolled heart valve disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
(8) Interstitial pneumonia, pulmonary fibrosis on chest CT.
(9) Complications such as a total unilateral lung atelectasis or an obstructive pneumonia.

Related Information

• Primary Sponsor: TAKAHASHI Toshiaki
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development