A
Indication details
- Combined Agent(s)
- Radiotherapy
- Control Arm
- Radiotherapy
- Therapeutic Indication
- Patients with SCCHN for locally advanced disease
- Tumour Type
-
Head and neck cancer
- Tumour Sub-type
- Squamous cell
- Tumour Stage
- Locally advanced
- Trial Name
- Study to compare RT alone with cetuximab–RT for locally advanced SCCHN
- NCT Number
- NCT00004227
- Trial Phase
- Phase III
Approval details
- FDA Approval
- FDA approved
- EMA Approval
- EMA approved
Primary Outcome(s)
- Primary Outcome(s)
- Locoregional control
- Evaluated Outcome
- OS
- Form(s)
- Form 1
Outcome Data
- OS Control
- 29.3 months, 5 year survival 36.4%
- OS Gain
- 19.7 months, 5 year survival gain 9.2%
- OS HR
- 0.73 (0.56-0.95)
Adjustments
- QoL Comment
-
No QoL benefit
Score (after adjustments)
- Curative score
-
A
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 384
- Scorecard version
- 1
- Issue date
- 07.08.2023
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.