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. 2015 Aug 2;2015(8):CD006849. doi: 10.1002/14651858.CD006849.pub3

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
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:
Outcomes OUTCOMES MEASURED:
 Tumour response
 Survival
 Toxicity
FOLLOW UP ASSESSMENT POINTS:
 OUTCOMES INCLUDED IN ANALYSES:
 Tumour response
 Survival
 Toxicity
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