non small cell lung cancer
Conditions
Interventions
PET/CT taken within one week of completion of chemoradiotherapy
Sponsors
Juntendo University Faculty of Medicine Urayasu Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have FDG-avid (SUVmax>4.0) and histologically or cytologically proven NSCLC Patients must be clinical American Joint Committee on Cancer (AJCC) stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated RT is planned FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration Thoracic CT scan (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) >= 1.2 L or >50% predicted without bronchodilator Performance status 0-1 Absolute neutrophil count>1,500 cells/mm3 (within 2 weeks prior to registration) Platelets > 100,000 cells/mm3 (within 2 weeks prior to registration) Haemoglobin > 10.0 g/dL (use of transfusion or other intervention to achieve this is acceptable) (within 2 weeks prior to registration) Serum creatinine within normal institutional limits or a creatinine clearance > 60 ml/min (within 2 weeks prior to registration) Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study The patient must provide study-specific informed consent prior to study entry
Exclusion criteria
Exclusion criteria: Patients with any component of small cell lung carcinomaPatients with evidence of a malignant pleural or pericardial effusion Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years Prior systemic chemotherapy for the studied cancer (prior chemotherapy for a different cancer is allowable) Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fieldsSevere, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Acquired immune deficiency syndrome based upon current Centres for Disease Control definition Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumour causing significant narrowing and destruction of that artery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare SUVmax, SUVpeak, SUVlbm, SUVbsa, TLG, and MTV,between PET/CT taken within one week of completion of chemoradiotherapy and PET/CT taken after completion of Durvalumab.Find the best method and cut of value for stratifying patients with viable tumours on PET/CT taken within one week of completion of chemoradiotherapy. | — |
Countries
Japan
Contacts
Public ContactAnneyuko Saito
Juntendo University Faculty of Medicine Urayasu Hospital Radiation Oncology
Outcome results
None listed