1. Michael Stahl on behalf of the German Oesophageal Cancer Study Group
Abstract No 4530, Poster No 18
Long term results of a phase III study investigating chemoradiation with and without surgery in locally advanced squamous cell carcinoma of the esophagus
Michael Stahl
on behalf of the
German Oesophageal Cancer Study Group

2. Participating Centers German Oesophageal Cancer Study Group
Essen (KEM, AKK, University, EKK)
Düsseldorf (University)
Tübingen (University)
Marburg (University)
Duisburg (St.J., Städt.)
Trier (KB)
Berlin (RRK)
Göttingen (University)
Mönchengladbach (Franz.)

3. Eligibility Criteria
SCC of the intrathoracic esophagus
Stage T3-4 N0-1 M0 according to CT und EUS
Medically fit for surgery, PS 0-1
Age up to 70 years
Written informed consent

4. Flow Diagram of Patients included
Excluded
(not meeting
inclusion criteria)
n = 5
Assessed
for eligibility
n = 189
Refused
randomisation
n = 12
Treated A
n = 7
Treated B
n = 5
Randomised
n = 172
Allocated to
Arm A
n = 86
Allocated to
Arm B
n = 86
Stahl M, et al
JCO 23:2310-7,
2005
Treated n = 86
Treated n = 85

5. Stratification Criteria
Center
Gender
Weight loss (up to vs. above 10% of BW)
Complete EUS
Stage (T3N0 vs. T3N+ vs. T4)

6. Endpoints Primary endpoint Overall survival Secondary endpoints
POET
GOeCSG
Primary endpoint
Overall survival
Secondary endpoints
Rate of R0-Resection
Rate of PCR
Postoperative Mortality
Local tumor control

7. Statistical design Test for equivalence between arms Id<15%I
- H0: 35% 2y-survival in Arm A; >20% Arm B
N= 175 , power of 80%, a=0.05

8. Results at Surgery Surgery 62 patients Resection 55 / 62 (89%)
ypT0 N0 M0 18 / 51 (35%)
ypT1-3 N0 M0 17 / 51 (33%)
ypT1-3 N1 M0 9 / 51 (18%)
ypT1-3 N0-1 M1 7 / 51 (14%)

9. Surgical Procedures Exploration 7 /62 Resection 55/62 (89%)
TTE 49/55 (89%)
THE 4/55
Other 1/55
Unknown 1/55

10. Treatment Related Mortality
CTX CRTX Surgery
Arm A 2/86(2.2%) /57(12.3%)
Arm B 2/85(2.3%) /5
all 4/171(2.3%) /62(11.3%)
Overall 8.2%, including 3 pts. with late toxicity

11. Patterns of Failure (treatment according to protocol)
Arm A* Arm B*
Any failure 31/56 (55%) 57/83 (69%)
Local+regional 14/31 (45%) 41/57 (72%)
Distant (only) 16/31 (52%) 14/57 (25%)
Unknown 1/31 ( 3%) 2/57 ( 3%)
* Arm A: CRTX (at least 36 Gy) + Resection, Arm B: CRTX (at least 59 Gy)

12. Overall Survival (JCO 2005)
Log-rank for equivalence
p = 0.04
2-YSR
38.8% vs. 35.4%

13. Overall Survival (December 2007)
5-YSR
27.9% vs. 17.0%
Calculated 10-YSR
19.2% vs 12.2%
Logrank p=0.36
HR ( )
CRTX with Surgery
CRTX alone

14. Survival as treated (no crossover)
5-YSR
28.0% vs. 17.0%
Calculated 10-YSR
19.8% vs 12.9%
Logrank p=0.48
HR ( )

15. Cox Regression Analysis
Progn. Factor HR (95%CI) p-value
CTX-Response (y/n) <0.0001
Treatment group (A/B)
Gender (m/f)
EUS complete (y/n)
Weight loss (</>10%)
Stage (T3N1/T3N0)
Stage (T4NX/T3N0)