JCOG2108: A multicenter randomized phase III study of systemic chemotherapy followed by maintenance therapy versus local consolidation therapy for postoperative oligometastatic recurrent non-small cell lung cancer (Oligo-R)
- Conditions
- Non-small cell lung cancere
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Criteria for the primary registration (1) Histologically completely resected non-small cell lung cancer. (2) Ninety days or more have passed since theinitial lung resection, and more than 180 days* have passed since the definitive diagnosis of lung cancer.
- The date of diagnosis is the date of the imaging test if diagnosed by imaging tests, or the date of the biopsy if diagnosed by pathological tests, or the earliest test date if multiple tests were used. (3) The initial pathological stage was I to III non-small cell lung cancer. (4) If there is a history of postoperative adjuvant chemotherapy, including immune checkpoint inhibitors such as anti-PD-1 antibodies, anti-PD-L1 antibodies, and anti-CTLA-4 antibodies, 180 days or more have passed since the last administration of postoperative adjuvant chemotherapy. The conditions is not applicable to UFT therapy. (5) All of the examinations including contrast-enhanced neck to pelvic CT, FDG-PET (PET/CT orPET/MRI), and contrast-enhanced brain MRI should fulfill all of the following criteria for oligometastases: a) The number of metastases is three or less. Lymph node metastases count as one metastasis per lymph node and are included in the number of metastatic organs. b) No local recurrence or resectable single mediastinal lymph node metastases without extranodal invasion, with a total of two or three oligo metastases including local recurrence. c) Regardless of the number of metastases, the metastases are not limited to the brain only, d) All of the following criteria are met for bone metastasis.
- Not metastasis to three consecutive vertebral bodies.
- Not vertebral metastasis (Bilsky grade 1b or higher) that shows progression into the spinal canal.
- Not long bone metastasis.
- Does not have severe pain that is poorly controlled by medication. e) All of the following criteria are met for brain metastasis.
- The largest tumor diameter is 3cm or less and as symptomatic.
- If there are multiple brain metastases, the total of the largest tumor diameter is 5 cm or less. (6) All metastatic lesions can be treated by local therapies as determined by the participating institution's surgeon or radiotherapist. (7) In non-squamous cell carcinoma, EGFR gene driver mutations (exon 19 deletion, L858R, G719X,L861Q, S7681, and these mutations with T190Mmutation) and ALK immunostaining/ALK fusion genes are negative (EGFR gene teting and ALK immunostaining/ALK fusion gene are not mandatory insquamous cell carcinoma). (8) ROS1 fusion gene, BRAF (V600E) gene mutation, MET exon 14 skipping mutation, RET fusion gene, and NTRK fusion gene are negative or unknown. (9) The age on the primary registration is 18 or older. (10) Performance status (PS) is 0 or 1 according to ECOG criteria (PS must always be recorded in the medical record). If PD-L1 TPS>=50%, PS 2 is acceptable. (11) No history of systemic chemotherapy for metastasis lesions, excluding preoperative and postoperative adjuvant chemotherapy. (12) Adequate function of major organs. (13) Written informed consent has been obtained from the patient to participate in the study.
Criteria for the secondary registration (1) Primary registration was performed, and 4courses (1 couse = 3 weeks) of induction therapy have been performed, or the induction therapy is terminated at the third courses due to adverse events. (2) No apparent increase in size(*) in any of metastases or new distatnt metastasis are observed.
- An apparent increase is considered when the long diameter of any lesion is increased by more than 10% and more than 5 mm compared to pre-treatment diameter. However, lymph nodes are evaluated by their short diameter. (3) The secondary registration date is within 28 days (4 weeks) of the response evaluation of induction therapy (if there are multiple image modalityes used for the evaluation, the date of the latest examination is adopted). (4) Within 64 days (9 weeks) to 182 days (26 weeks) after primary registration. (5) No metastatic site larger than 3 cm in tumor diameter. (6) If brain metastases are found at the time of primary registration, radical local therapy (stereotactic irradiation or stereotactic radiotherapy) has been performed. (7) Al least one oligometastasis that canbe treatedlocally remains. However, brain lesions where radical local therapy has been performed are not included. (8) All metastatic lesions can be treated by local therapies as determined by the participating institution's surgeon or radiotherapist. (9) PS is 0 or 1 according to ECOG criteria (PS must always be recorded in the medical record). If PD-L1 TPS>=50%, PS 2 is acceptable. (10) Adequate function of major organs before the secondary resistrartion.
(1) Simultaneous or metachronous (within 2 years) double cancers, with the exception of intramucosal tumor curable with local therapy. However, even if the disease-free period is less than 2 years, the following are not considered to be active second primary cancers: prostate cancer in clinical stage I, laryngeal cancer in clinical stages 0 and I that have responded completely to radiation therapy, completely resected lung adenocarcinoma without vascular invasion Stage 0-IA2 (regardless of surgical method), cancers with a 5-year relative survival rate of 95% or more, such as cancers with the following pathological stages (cancers with a history of complete resection are not included in the category of active multiple cancers/multiple cancers).
(2) Active infection requiring systemic therapy.
(3) Fever over 38 degrees Celsius
(4) Female during pregnancy, within 28 days of postparturition, or during lactation. Male who wants partner's pregnancy.
(5) Psychological disorder difficult to participate in this clinical study.
(6) Receiving a continuous systemic administration (oral or intravenous) of steroids exceeding 10 mg/day in predonisolone equivalents, or other immunosuppressive drugs.
(7) Uncontrollable diabetes mellitus.
(8) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration.
(9) Have an uncontrolled valvular disease, dilated cardiomyopathy, hypertrophic cardiomyopathy.
(10) One or a combination of the following conditions diagnosed via chest CT scan: interstitial pneumonia, severe pulmonary fibrosis, or seveare emphysema.
(11) Positive HBs antigen and/or HCV antibody.
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method - Overall Survival
- Secondary Outcome Measures
Name Time Method Progression lesions oligometastases, non-oligometastases
Quality of life FACT-TOI, EQ-5D-5L