Wolf 1987.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES: 14 German hospitals
DURATION OF STUDY: December 1983 to December 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:
Histologic proof of small cell lung cancer
Signs of measurable or evaluable disease
Karnofsky Performance Status of 50% of more
Informed patient's consent EXCLUSION CRITERIA: Age > 70 years Prior treatment (chemotherapy, radiotherapy or surgery) Existence of accessory malignant disease Evidence of renal dysfunction Chronic hepatic disease Advanced respiratory or cardiac insufficiency N RANDOMISED: 141 ASSESS STAGE: Yes (N LIMITED): 54 (PE ‐ 27; IE ‐ 27) (N EXTENSIVE): 87 (PE ‐ 46; IE ‐ 41) M: 127 (PE ‐ 65; IE ‐ 62) F: 14 (PE ‐ 8; IE ‐ 6) AGE: |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
PE ‐ cisplatin 80 mg/m2, IV on day 1 and etoposide 150 mg/m2, IV on days 3 through 5. IE ‐ ifosfamide, 1500 mg/m2 IV on days 1 through 5 and etoposide 120 mg/m2 IV on days 3 through 5. A maximum of 6 cycles as administered in 3‐week intervals CO‐INTERVENTIONS: In both arms, second‐line therapy consisted of CAV ‐ cyclophosphamide 600 mg/m2 IV on days 1 and 2, Adriamycin 50 mg/m2 IV on day 1 and vincristine 2 mg IV on day 1. Chest irradiation was applied to patients in both arms. In limited stage, 45 Gy was administered. Patients achieving a complete response received prophylactic cranial irradiation after the third cycle of chemotherapy respectively after the onset of complete response. Patients with cranial metastases received brain irradiation immediately. Painful metastases were irradiated as necessary. CLASSIFICATION OF INTERVENTION (ADJUVANT/NEO‐ADJUVANT/PALLIATIVE): Palliative |
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| Outcomes | OUTCOMES MEASURED:
Tumour response
Survival
Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Survival Tumour response |
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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 |
ED = extensive disease IV = intravenous LD = limited disease SCLC = small cell lung cancer