4
Indication details
- Control Arm
- Chemotherapy
- FDA Therapeutic Indication
- Indicated for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Oesophageal squamous cell carcinoma
- Tumour Stage
- Unresectable locally advanced or metastatic
- Trial Name
- RATIONALE 302
- NCT Number
- NCT03430843
- Trial Phase
- Phase III
Approval details
- FDA Approval
- not FDA approved
- EMA Approval
- EMA (CHMP) July 2023 EC decision September 2023
Primary Outcome(s)
- Primary Outcome(s)
- OS (ITT)
- Evaluated Outcome
- OS
Outcome Data
- OS Control
- 6.3 months
- OS Gain
- 2.3 months
- OS HR
- 0.70 (0.57-0.85)
Adjustments
- QoL Comment
-
Improved QoL
- Toxicity Comment
-
Less serious adverse events observed
Score (after adjustments)
- Preliminary non-curative score
-
3
- Toxicity adjustment
- 1+
- Non-curative score
-
4
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 394
- Scorecard version
- 1
- Issue date
- 18.08.2023
- Last update
- 26.09.2024
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.