Goodman 1990.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES:
DURATION OF STUDY: September 1982 to September 1984
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 previously untreated limited disease SCLC EXCLUSION CRITERIA: Patients with extensive disease SCLC N RANDOMISED: 388 ASSESS STAGE: Yes (LD only) (N LIMITED): 388 (N EXTENSIVE): M: 247 F: 141 AGE: Median 61 in both arms |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
EVAC ‐ VP‐16, 75 mg/m2 IV on days 1, 2 and 3, vincristine 1.0 mg/m2 IV on days 1 and 8, Adriamycin 40 mg/m2 IV on day 1, cyclophosphamide 750 mg/m2 IV on day 1
Treatment was repeated every 3 weeks for 6 cycles VP‐16/CDDP alternating with VAC ‐ VP‐16 100 mg/m2 IV on days 1, 2 and 3, CDDP 100 mg/m2 IV on day 1, vincristine 1.0 mg/m2 IV on days 22 and 29, Adriamycin 50 mg/m2 IV on day 22, cyclophosphamide, 750 mg/m2 on day 22 Treatment was repeated every 6 weeks for a total of 6 cycles CO‐INTERVENTIONS: Chest irradiation Prophylactic cranial irradiation CLASSIFICATION OF INTERVENTION (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Survival
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 |