3
Indication details
- Combined Agent(s)
- Best supportive care
- Control Arm
- Placebo
- Therapeutic Indication
- Unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Neuroendocrine Tumour - Pancreatic
- Tumour Stage
- Unresectable or metastatic
- Trial Name
- RADIANT 3
- NCT Number
- NCT00510068
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- PFS ITT (crossover allowed)
- Evaluated Outcome
- PFS
- Form(s)
- Form 2b
Outcome Data
- PFS Control
- 4.6 months
- PFS Gain
- 6.4 months
- PFS HR
- 0.35 (0.27-0.45)
- OS Control
- 37.7 months
- OS Gain
- 6.3 months (not statistically significant)
- OS HR
- 0.94 (0.73-1.20) not significant
Adjustments
- QoL Comment
-
No QoL data
- Toxicity Comment
-
Moderate toxicity
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
- Comment
-
EMA approved
Not FDA approved
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 149
- Scorecard version
- 1
- Issue date
- 12.03.2020
- Last update
- 08.03.2023
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.