Lebeau 1994.
| Study characteristics | ||
| Methods | Trial acronym: 02 PC 85, run by the "Petites Cellules" group Design: multicentre, open‐label, randomised substudy, with intention‐to‐treat analyses Median duration of follow‐up: not reported |
|
| Participants | Patients with limited and extensive small‐cell lung cancer who had not been previously treated with chemotherapy or radiotherapy Mean age: not reported overall; 42 (15%) < 50 years; 104 (38%) 50–59 years; 88 (32%) 60–69 years, 44 (16%) 70–81 years Gender, n (%) males: 120 (87%) in heparin group; 132 (95%) in control group Metastatic disease, n (%): extensive disease: 74 (54%) in heparin group; 82 (59%) in control group Previous VTE: not reported |
|
| Interventions | Intervention: chemotherapy with SC UFH. The dose of UFH was initially adapted to weight (500 IU/kg/day) then adjusted by clotting times. UFH was administered in 2 or 3 daily injections for 5 weeks and stopped 1 week after the second course of chemotherapy. Control: chemotherapy without UFH |
|
| Outcomes | Primary outcome: overall survival, response to chemotherapy Secondary outcomes: bleeding, UFH‐related thrombocytopenia |
|
| Notes | Funding: none reported Disclosure of potential conflicts of interest: not disclosed, no COI forms available Publication format: full‐text publication |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomized through a centralized blind telephone assignment procedure." Comment: method of sequence generation not clearly reported. |
| Allocation concealment (selection bias) | Low risk | Quote: "randomized through a centralized blind telephone assignment procedure." Comment: adequate method of allocation concealment. |
| Blinding (performance bias and detection bias) All outcomes | High risk | Quote: "No bIinding procedure for patients and physicians was used." Comment: open‐label study with no blinding of participants or physicians. Not reported if there was blinding of outcome assessors. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "No patient was lost to follow up." Comment: all participants enrolled in the randomised substudy were analysed. |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported in the methods section were addressed in the results section. |