1. Evaluation of the recommended dose for phase-II-trial (Time Frame - 18 months): Evaluation of the toxicity-profile of D,L-methadone and the dose-limiting toxicity (DLT) in combination with mFOLFOX6
2. Disease control rate 12 weeks after randomization (ITT-population) (Time Frame - 12 weeks after randomization): Evaluation of the disease control rate of D,L-methadone plus mFOLFOX6 compared to mFOLFOX6 alone in the treatment of patients with advanced colorectal cancer. The disease control rate is defined as response (CR or PR) or stabilization (SD) of the tumor disease at 12 weeks after randomization (DCR) according to RECIST1.1.
Secondary outcome:
1. Disease control rate (DCR) 12 weeks after randomization (per-protocol-population) (Time Frame - 12 weeks): The disease control rate is defined as response (CR or PR) or stabilization (SD) of the tumor disease at 12 weeks after randomization (DCR) according to RECIST1.1
2. Overall response rate (Time Frame - 46 months): All tumor evaluation is performed according to RECIST 1.1
3. patient diary (Time Frame - 46 months): Collection compliance with a diary
4. Progression-free survival (Time Frame - after 46 months): Progression-free survival (PFS) will be defined as the time from randomization to the time of progress (according to RECIST 1.1) or death, or to the date of last tumor assessment without any such event (censored observation)
5. Overall survival (Time Frame - 46 months): The duration of overall survival (OS) will be determined by measuring the time interval from randomization to the date of death or last observation (censored)
6. Quality of life assessment (Time Frame - 46 months): EORTC QLQ-C30 ("European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)" ).
The EORTC QLQ-C30 is composed of a global health status/QoL-score, five function scales, three symptom scales and five single items (dyspnea, insomnia, appetite loss, constipation, diarrhea). Each item has four response alternatives: (1) "not at all", (2) "a little", (3) "quite a bit", and (4) "very much" - except the two items of the global health-status/quality of life scale which have response options ranging from (1) "very poor" to (7) "excellent".
7. Adverse events (Time Frame - 46 months): Evaluation of the safety- and tolerability profile
Maximum tolerated dose, MTD: D,L-methadone hydrochloride (Methasan® 10 mg/ml): Dose Level D,L-methadone hydrochloride (Methasan® 10 mg/ml) In dose level I a maximum of 30 mg/day (15 mg (1,5 ml) 1-0-1) In dose level II a maximum of 35 mg/ day (17.5 mg (1,75 ml) 1-0-1) In dose level III a maximum of 40 mg/day (20 mg (2,0 ml) 1-0-1)
Quelle: ClinicalTrials.gov
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"D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer"
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