Urban 1999a.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES: France
DURATION OF STUDY: October 1 1985 to April 30 1988
CONCEALMENT OF ALLOCATION: C
DESCRIBED AS RANDOMISED: Yes
DESCRIBED AS DOUBLE BLIND: No
METHOD OF RANDOMISATION WELL‐DESCRIBED/APPROPRIATE: Not described
METHOD OF BLINDING WELL‐DESCRIBED/APPROPRIATE: Not described
DESCRIPTION OF WITHDRAWALS/DROP‐OUTS: Yes GRADE ASSESSMENT QUALITY RATING: High TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY INCLUSION CRITERIA: Patients with proven small cell lung cancer. There were no eligibility restrictions in terms of age, sex, performance status or extent of disease. EXCLUSION CRITERIA: Patients with associated neoplasia, heart failure or renal failure and patients previously treated by surgery, chemotherapy or radiation were eligible for this trial. N RANDOMISED: 394 (standard ‐ 203; alternating ‐ 191) ASSESS STAGE: Yes (N LIMITED): 169 (N EXTENSIVE): 225 M: 361 F: 33 AGE: median: standard ‐ 59 ± 11, alternating ‐ 60 ± 19 (range: standard ‐ 28 to 79; alternating ‐ 29 to 81) | |
| Interventions | TYPE: Chemotherapy
REGIMENS:
Standard regimen ‐ (CCVAP 16) consisted of CCNU 80 mg orally, cyclophosphamide 1000 mg/m2 IV d1, doxorubicin 45 mg/m2 IV d1, and VP 16 225 mg/m2 IV d1.
Alternating regimen ‐ consisted of sequence B with CCNU 80 mg orally d1, cyclophosphamide 1000 mg/m2 IV d1, and doxorubicin 45 mg/m2 IV d1 alternating at 4‐weekly intervals with sequence C, consisting of cisplatin 80 mg/m2 IV d1, vindesine 3 mg/m2 IV d1, and VP 16 225 mg/m2 IV d1. Courses of therapy were administered every 28 days in the 2 groups. CO‐INTERVENTIONS: Thoracic irradiation was scheduled for patients with limited forms of disease after 2 cycles of chemotherapy in the case of no response. Thoracic irradiation delivered 45 to 50 Grays equivalent. Cephalic irradiation was administered to patients with cerebral metastases ‐ 40 Grays equivalent or recommended prophylactically ‐ 24 to 30 Grays equivalent in the case of complete response. |
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| Outcomes | OUTCOMES MEASURED: Survival Tumour response (defined as best response for at least 1 month at any time during treatment) Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Survival Tumour response (defined as best response for at least 1 month at any time during treatment) Toxicity | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Sequence generation reported and adequate |
| Allocation concealment (selection bias) | High risk | Allocation concealment not adequate |
| Blinding (performance bias and detection bias) Participants | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Investigators | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Survival | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Tumour Response | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Toxicity | Unclear risk | Not reported |
| Blinding (performance bias and detection bias) Quality of Life | Unclear risk | N/A |
| Incomplete outcome data (attrition bias) Survival | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Tumour Response | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Toxicity | Low risk | Reasons for withdrawals, drop‐outs and exclusions reported |
| Incomplete outcome data (attrition bias) Quality of Life | Unclear risk | N/A |
| Selective reporting (reporting bias) | Low risk | Adequate |
| Other bias | Low risk | Adequate |