Fukuoka 1986.
| Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES: Osaka Prefectural Habikino Hospital, single centre.
DURATION OF STUDY: August 1982 to April 1985
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: Histologically or cytologically confirmed SCLC, age <= 79 years, a performance status (ECOG scale) of 0 to 3, with no prior therapy, with measurable or evaluable disease, with adequate bone marrow function (white blood cells [WBC] >= 4000/mm3, platelets >= 10 x 104/mm3), serum creatinine <1.5 mg/dl, serum glutamine oxaloacetic transaminase and glutamine pyruvic transaminase < 2 x normal, with normal cardiac function and no other malignant disease. EXCLUSION CRITERIA: N SCREENED: 71 (69 eligible) N RANDOMISED: 69 (continuous ‐ 34; alternating ‐ 35) N COMPLETED: ASSESS STAGE: Yes (N LIMITED): 21 (N EXTENSIVE): 48 M: 55 F: 14 AGE: mean: continuous ‐ 61.5; alternating ‐ 62.1 (range: continuous ‐ 40 to 77, alternating ‐ 36 to 74) |
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| Interventions | TYPE: Chemotherapy
REGIMENS:
The continuous regimen (CONP) consisted of nimustine hydrochloride (ACNU: 70 mg/m2 IV on day 1), cyclophosphamide (700 mg/m2 IV on day 2), oncovin (0.7 mg/m2 IV on day 2) and procarbazine (100 mg/m2 body surface‐area orally on days 1 to 7). This regimen was repeated every 4 weeks.
The alternating regimen (CONPVAD) consisted of CONP treatment as described above, followed by treatment with VAD, which contained etoposide (VP‐16) (60 mg/m2 IV on days 1 to 4), Adriamycin (30 mg/m2 IV on day 1), and cisplatin (DDP: 60 mg/m2 IV with 2600 ml hydration and diuresis on day 1). Thus, CONP was alternated with VAD at 4‐week intervals. CO‐INTERVENTIONS: Radiation therapy was performed on primary lesions and the mediastinum at the time of expected maximum response to all patients with LD |
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| Outcomes | OUTCOMES MEASURED:
Tumour response
Response duration
Survival
Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response Survival Toxicity |
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| Notes | Other: Patients with pleural effusion were excluded from LD (limited disease) | |
| 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 |