A
Indication details
- Control Arm
- Gemcitabine
- Therapeutic Indication
- Adjuvant therapy following resection for pancreatic cancer
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Pancreatic cancer
- Tumour Stage
- Early
- Trial Name
- PRODIGE 24/CCTG PA.6
- NCT Number
- NCT01526135
- Trial Phase
- Phase III
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 35.5 months
- OS Gain
- 18.0 months 5-year survival gain 11.8%
- OS HR
- 0.68 (0.54-0.85)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
- Toxicity Comment
-
Increased acute toxicity
Score (after adjustments)
- Curative score
-
A
- Comment
-
Regimen without a specific licensed indication in pancreatic cancer
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 121
- Scorecard version
- 1
- Issue date
- 14.05.2019
- Last update
- 19.07.2023
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.