{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"6"}],"units":"Participants"}],"description":"Local failure is defined as local enlargement (LE) or local failure (LF) tumor response, marginal failure (MF), or death. LFFS was to be estimated by the Kaplan-Meier method and arms compared by log-rank test. Analysis was to occur when at least 105 deaths had been reported. Given the small number of participants due to early study closure, only the number of patients last reported to be alive without failure at time of study termination is reported, and no statistical testing was done.\n\nLE: ≥ 20% increase in the largest diameter (LD) of target lesion from the smallest LD recorded since the treatment start; based on computed tomography (CT) scan.\n\nLF: Progression of pleural tumor thickness or appearance of a site of pleural thickness \\> 5 mm in the site of treated tumor.\n\nMF: The appearance of a new measurable site of pleural tumor \\> 5mm within the treated site or enlarging tumor dimensions corresponding to a 20% increase in LD compared to initial appearance on imaging evaluation.","groups":[{"description":"\\[Intent-to-treat\\]\n\nSTEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1.\n\nSTEP 2 (randomized): Patients receive no treatment.","id":"OG000","title":"Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)"},{"description":"\\[Intent-to-treat\\]\n\nSTEP 1 (all patients): Same as Arm 1.\n\nSTEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.","id":"OG001","title":"Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Randomized patients","reportingStatus":"POSTED","timeFrame":"From randomization to local failure, death, or last follow-up, whichever occurs first. Maximum follow-up was 25 months.","title":"Local-failure-free Survival (LFFS)","type":"SECONDARY","unitOfMeasure":"Participants"}