Creech 1982.
Methods | STUDY DESIGN: Parallel study
LOCATION, NUMBER OF CENTRES:
DURATION OF STUDY: September 1978 to October 1979
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: Yes GRADE ASSESSMENT QUALITY RATING: Moderate TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT |
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Participants | INCLUSION CRITERIA: Each patient had to be refractory to standard chemotherapy; have measurable or evaluable disease; an Eastern Cooperative Oncology Group performance status of 0 to 2; a white blood cell count >= 4000/mm3, a platelet count >= 100,000/mm3, a BUN <= 25 mg/100 mL, a creatinine < 1.5 mg/100 mL, and a bilirubin <= 2.0 mg/100 mL. All patients gave informed written consent prior to participation in this study. EXCLUSION CRITERIA: N SCREENED: 73 (58 evaluable) N RANDOMISED: 58 (cisplatin ‐ 21; maytansine ‐ 19; chlorozotocin ‐ 18) N COMPLETED: ASSESS STAGE: No (N LIMITED): (N EXTENSIVE): M: F: AGE: | |
Interventions | TYPE: Chemotherapy
REGIMENS:
Cisplatin ‐ 75 mg/m2 intravenous (IV) Cisplatin every 21 days after adequate hydration and diuresis.
Maytansine ‐ maytansine 1.5 mg/m2 IV every 21 days.
Chlorozotocin ‐ chlorozotocin 120 mg/m2 IV every 42 days. Each drug was given until there was clinical evidence of progressive disease, after which patients were not eligible for treatment with the other study drugs. CO‐INTERVENTIONS: |
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Outcomes | OUTCOMES MEASURED:
Tumour response
Survival
Toxicity FOLLOW UP ASSESSMENT POINTS: OUTCOMES INCLUDED IN ANALYSES: Tumour response Survival 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 | N/A |
Blinding (performance bias and detection bias) Tumour Response | Unclear risk | Not reported |
Blinding (performance bias and detection bias) Toxicity | Unclear risk | N/A |
Blinding (performance bias and detection bias) Quality of Life | Unclear risk | N/A |
Incomplete outcome data (attrition bias) Survival | Unclear risk | N/A |
Incomplete outcome data (attrition bias) Tumour Response | High risk | Reasons for withdrawals, drop‐outs and exclusions not reported |
Incomplete outcome data (attrition bias) Toxicity | Unclear risk | N/A |
Incomplete outcome data (attrition bias) Quality of Life | Unclear risk | N/A |
Selective reporting (reporting bias) | High risk | No mention of survival ‐ an expected outcome |
Other bias | Low risk | Adequate |