1
Indication details
- Control Arm
- Placebo
- Therapeutic Indication
- Advanced gastric cancer or gastroesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine ChT, when treatment in combination with paclitaxel is not appropriate
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Gastric or gastroesophageal junction adenocarcinoma
- Tumour Stage
- Advanced
- Trial Name
- REGARD
- NCT Number
- NCT00917384
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval April 2014
- EMA Approval
- EMA (CHMP) September 2014 EC decision January 2015
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- OS Control
- 3.8 months
- OS Gain
- 1.4 months
- OS HR
- 0.776 (0.603 - 0.998) (P = 0.047)
Adjustments
- QoL Comment
-
Not eligible for QoL evaluation due to low completion rates
Final Score (after adjustments)
- Preliminary non-curative score
-
1
- Final non-curative score
-
1
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 32
- Scorecard version
- 1
- Issue date
- 11.12.2018
- Last update
- 28.11.2023
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.