Urban 1999b.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES: Multicentre, 39 French centres
DURATION OF STUDY: May 1988 to May 1994
CONCEALMENT OF ALLOCATION: C
DESCRIBED AS RANDOMISED: Yes
DESCRIBED AS DOUBLE BLIND: No
METHOD OF RANDOMISATION WELL‐DESCRIBED/APPROPRIATE: Appropriate
METHOD OF BLINDING WELL‐DESCRIBED/APPROPRIATE: Not described
DESCRIPTION OF WITHDRAWALS/DROP‐OUTS: Not described GRADE ASSESSMENT QUALITY RATING: Moderate TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY
INCLUSION CRITERIA:
Biopsy confirmed limited or extensive disease SCLC EXCLUSION CRITERIA: Patients who had undergone thoracic surgery to remove the tumour Patients who had been treated previously with chemotherapy and radiotherapy Patients for whom close follow up would be unlikely Age >70 years, renal or hepatic disease, serious cardiac disease, history of prior malignant tumour in the past 5 years Patients who did not meet the standard criteria for haematological status N RANDOMISED: 457 ASSESS STAGE: Yes (N LIMITED): 97 (N EXTENSIVE): 360 M:37 F: 420 AGE: Mean CDE ‐ 57 +/‐ 9 years; PCDE ‐ 56 +/‐ 10 years |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
CDE ‐ Cyclophosphamide (1000 mg/m2 on day 1), doxorubicin (45 mg/m2 on day 1) and etoposide (150 mg/m2 on days 1 and 2) PCDE ‐ Cisplatin (100 mg/mm2 on day 1), cyclophosphamide (1000 mg/m2 on day 1), doxorubicin (45 mg/m2 on day 1) and etoposide (150 mg/m2 on days 1 and 2) Chemotherapy was administered every 4 weeks for a total of 6 courses CO‐INTERVENTIONS: Thoracic radiotherapy Prophylactic brain irradiation Brain irradiation CLASSIFICATION OF INTERVENTION: (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Survival
Tumour response
Haematologic toxicity
Mortality related to toxic events FOLLOW UP ASSESSMENT POINTS: Monthly during treatment 2‐monthly after treatment up to 1 year 3‐monthly from 1 year after treatment OUTCOMES INCLUDED IN ANALYSES: Survival Tumour response Haematologic toxicity Mortality related to toxic events |
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| 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 | High risk | Reasons for withdrawals, drop‐outs and exclusions not reported |
| Incomplete outcome data (attrition bias) Tumour Response | High risk | Reasons for withdrawals, drop‐outs and exclusions not reported |
| Incomplete outcome data (attrition bias) Toxicity | High risk | Reasons for withdrawals, drop‐outs and exclusions not 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 |