Wampler 1991.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES:
DURATION OF STUDY: November 1983 to November 1987
CONCEALMENT OF ALLOCATION: D
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: Not described GRADE ASSESSMENT QUALITY RATING: Low TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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| Participants | ELIGIBILITY
INCLUSION CRITERIA:
Patients with histologically or cytologically documented extensive disease SCLC without prior treatment
A performance status of 0, 1, 2 or 3
Adequate marrow, renal and hepatic function EXCLUSION CRITERIA: N RANDOMISED: 167 ASSESS STAGE: Yes (ED only) (N LIMITED): (N EXTENSIVE): 167 M: 113 F: 54 AGE: |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
CAV ‐ 3‐week cycle of cyclophosphamide (1200 mg/m2), doxorubicin (45 mg/m2), vincristine (1.4 mg/m2, maximum dose 2 mg) all on day 1 MEP/CAV ‐ 3‐weekly alternating cycles of MEP ‐ methotrexate (40 mg/m2 on day 1), etopside (100 mg/m2 on days 1, 2, 3) and cisplatin (100 mg/m2 on day 3) CAV ‐ cyclophosphamide (1200 mg/m2), doxorubicin (45 mg/m2), vincristine (1.4 mg/m2, maximum dose 2 mg) all on day 1 CO‐INTERVENTIONS: CLASSIFICATION OF INTERVENTION (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Survival
Time to progression
Tumour response
Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Survival Tumour response Toxicity |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| 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 |