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
- Conditions
- on-small cell lung cancere
- Registration Number
- JPRN-jRCTs031230475
- Lead Sponsor
- Watanabe Shun-ichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Criteria for the primary registration
(1) Histologically completely resected non-small cell lung cancer.
(2) One hundred and eighty days or more have passed since the initial lung resection.
(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 (*1), FDG-PET (or PET/CT), and contrast-enhanced brain MRI (*2) should fulfill all of the following criteria for oligometastases:
*1 If the use of contrast media is not possible due to the allergy, renal dysfunction, or bronchial asthma, unenhanced CT is acceptable.
*2 If the use of contrast media is not possible due to the allergy, renal dysfunction, or bronchial asthma, unenhanced MRI is permissible. If MRI is not possible due to a pacemaker or claustrophobia, evaluation by CT is permissible.
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 (*3), regardless of the number of metastases.
*3 This study defines local recurrence as recurrence at the resection margin, including the bronchial stump, the hilar and mediastinal lymph nodes on the ipsilateral side as the primary lesion, the hilar and mediastinal lymph nodes on the contralateral side, the intrapulmonary lymph nodes on the ipsilateral side, malignant pleural effusion on the ipsilateral side, and disseminations on the ipsilateral
c) If the number of metastasis is one, it should not be limited to one lung nodule.
d) Regardless of the number of metastases, the metastases are not limited to the brain only,
e) 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.
f) All of the following criterial are met for brain metastasis.
- The largest tumor diameter is 3cm or less and asymptomatic.
- If there are multiple brain metastases, the total of the 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 T190M mutation) and ALK immunostaining/ALK fusion genes are negative (EGFR gene teting and ALK immunostaining/ALK fusion gene are not mandatory in squamous 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).
(11) No history of systemic chemotherapy for metastasis lesions, excluding preoperative and postoperative adjuvant chemotherapy.
(12) The latest values within 14 days before the primary resistrart
(1) Simultaneous or metachronous (within 2 years) double cancers, with the exception of intramucosal tumor curable with local therapy.
(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
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival
- Secondary Outcome Measures
Name Time Method Progression-free survival, Progression lesions (oligometastases, non-oligometastases), Oligometastases-free survival by type of local therapy, Adverse event rate, Severe adverse event rate, Quality of life (FACT-TOI, EQ-5D-5L )