A
Indication details
- Combined Agent(s)
- Oxaliplatin–S-1 + surgery + adjuvant S-1
- Control Arm
- Surgery + adjuvant S-1
- FDA Therapeutic Indication
- Peri-operative therapy for the treatment of resectable advanced gastric cancer
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric Cancer
- Tumour Stage
- Neoadjuvant
- Trial Name
- PRODIGY
- NCT Number
- NCT01515748
- Trial Phase
- Phase III
Approval details
- Comment
- No specific licensed indication in gastric cancer
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 1
Outcome Data
- PFS Control
- 5-year: 55.6%
- PFS Gain
- 5-year: 4.8%
- PFS HR
- 0.70 (0.52-0.95)
- OS Control
- OS not significant (immature)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1
- Scorecard ID
- 406
- Scorecard version
- 1
- Issue date
- 29.11.2023
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.