3
Indication details
- Control Arm
- Placebo
- FDA Therapeutic Indication
- Treatment of patients with mCRC in patients who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based ChT, anti-VEGF agents and anti-EGFR agents
- Tumour Type
-
Gastrointestinal Cancers
- Tumour Sub-type
- Colorectal Cancer
- Tumour Stage
- Metastatic
- Trial Name
- RECOURSE
- NCT Number
- NCT01607957
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approval September 2015
- EMA Approval
- EMA (CHMP) approval February 2016 EC decision April 2016
Primary Outcome(s)
- Primary Outcome(s)
- OS
- Evaluated Outcome
- OS
- Form(s)
- Form 2a
Outcome Data
- PFS Control
- 1.7 months
- PFS Gain
- 0.3 months
- PFS HR
- 0.48 (0.41-0.57)
- OS Control
- 5.2 months
- OS Gain
- 2.0 months
- OS HR
- 0.69 (0.59-0.81)
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 300
- Scorecard version
- 1
- Issue date
- 25.10.2021
- Last update
- 08.02.2024
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.