Eagan 1981.
| Methods | STUDY DESIGN: Parallel group
LOCATION, NUMBER OF CENTRES:
DURATION OF STUDY: July 1976 to July 1978
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: Previously untreated limited stage small cell lung cancer EXCLUSION CRITERIA: Patients with significant cardiac disease or serum creatinines > 1.5 mg/dl N RANDOMISED: 62 N COMPLETED: ASSESS STAGE: Yes (N LIMITED): 62 (VOCA ‐ 31; VOCAP ‐ 31) (N EXTENSIVE): 0 M: 45 (VOCA ‐ 22; VOCAP ‐ 23) F: 17 (VOCA ‐ 9; VOCAP ‐ 8) AGE: Median VOCA ‐ 58 (39 to 74); VOCAP ‐ 59 (38 to 77) |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
VOCA ‐ VP‐16 50 mg/m2 IV on days 1, 2 and 3; vincristine (Oncovin) 1.4 mg/m2 IV on day 1; cyclophosphamide 150 mg/m2 IV on days 1, 2 and 3; and Adriamycin 15 mg/m2 IV on days 1, 2 and 3. VOCAP ‐ VP‐16 50 mg/m2 IV on days 1, 2 and 3; vincristine (Oncovin) 1.4 mg/m2 IV on day 1; cyclophosphamide 150 mg/m2 IV on days 1, 2 and 3; Adriamycin 15 mg/m2 IV on days 1, 2 and 3; and cisplatin 40 mg/m2 IV on day 1. Both treatment arms were administered for 8 cycles CO‐INTERVENTIONS: Thoracic radiation therapy was administered concomitantly with the third and fourth courses of chemotherapy CLASSIFICATION OF INTERVENTION: (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Regression rates
Time to progression
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) | Unclear risk | Insufficient information |
| Other bias | Low risk | Adequate |