Trial Outcomes & Findings for Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer (NCT NCT01787006)
NCT ID: NCT01787006
Last Updated: 2020-03-10
Results Overview
Overall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the day of randomization, and the patients were followed for a maximum of 24 months (2 years).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
2 years
Results posted on
2020-03-10
Participant Flow
Participant milestones
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
39
|
|
Overall Study
COMPLETED
|
32
|
36
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer
Baseline characteristics by cohort
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
median
|
65 years
n=5 Participants
|
64 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Caucasian
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnic origin · Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
32 participants
n=5 Participants
|
36 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Histology
Adeno carcinoma
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Histologic grading
G1
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Histologic grading
G2
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Histologic grading
G3
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Histologic grading
Gx
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
clinical T-category
cT1
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
clinical T-category
cT2
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
clinical T-category
cT3
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
clinical T-category
cT4
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
clinical T-category
cTx
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
clinical N-category
cN0
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
clinical N-category
cN1
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
clinical N-category
cN2
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
clinical N-category
cN3
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
clinical N-category
cNx
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
clinical N-category
cN+
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
clinical M-category
cM0
|
31 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
clinical M-category
cM1 (formerly cM1a)
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
clinical M-category
cMx
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tumor site
Lower third only
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Tumor site
Lower and middle third
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Tumor site
Middle third only
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Tumor site
Upper and middle third
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Tumor site
Upper third only
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Tumor site
Not specified
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Karnofsky Performance Score (KPS)
KPS of 70
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Karnofsky Performance Score (KPS)
KPS of 80-100
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOverall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the day of randomization, and the patients were followed for a maximum of 24 months (2 years).
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive at 2 Years
|
71 percentage of participants
Interval 55.0 to 87.0
|
53 percentage of participants
Interval 36.0 to 71.0
|
SECONDARY outcome
Timeframe: 1 yearOverall Survival (OS) was defined as freedom from death of any cause. Time to death was calculated from the day of randomization.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive at 1 Year
|
74 percentage of participants
Interval 59.0 to 90.0
|
70 percentage of participants
Interval 54.0 to 86.0
|
SECONDARY outcome
Timeframe: 1 yearFor progression-free survival (PFS), the event was defined as first occurrence of radiologically proven progression or clinical progression or death due to progressive disease. Time to event was referenced from the day of randomization.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive Without Progression of Disease at 1 Year
|
64 percentage of participants
Interval 47.0 to 82.0
|
58 percentage of participants
Interval 40.0 to 75.0
|
SECONDARY outcome
Timeframe: 2 yearsFor progression-free survival (PFS), the event was defined as first occurrence of radiologically proven progression or clinical progression or death due to progressive disease. Time to event was referenced from the day of randomization.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive Without Progression of Disease at 2 Years
|
56 percentage of participants
Interval 37.0 to 75.0
|
44 percentage of participants
Interval 26.0 to 62.0
|
SECONDARY outcome
Timeframe: up to 2 yearsToxicity was assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03).
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Number of Participants Experiencing at Least One Grade >=3 Toxicity
at least one grade >=3 toxicity
|
26 Participants
|
27 Participants
|
|
Number of Participants Experiencing at Least One Grade >=3 Toxicity
no grade >=3 toxicity
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 1 yearFor metastases-free survival (MFS), the event was defined as first occurrence of distant metastasis. Time to event was referenced from the day of randomization.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive Without Distant Metastases at 1 Year
|
79 percentage of participants
Interval 64.0 to 94.0
|
70 percentage of participants
Interval 53.0 to 86.0
|
SECONDARY outcome
Timeframe: 2 yearsFor metastases-free survival (MFS), the event was defined as first occurrence of distant metastasis. Time to event was referenced from the day of randomization.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive Without Distant Metastases at 2 Years
|
74 percentage of participants
Interval 57.0 to 91.0
|
54 percentage of participants
Interval 36.0 to 73.0
|
SECONDARY outcome
Timeframe: up to 2 yearsResponse was defined according to the RECIST criteria (Version 1.1) based on the assessments (computed tomography, magnetic resonance imaging or other) for target lesions, non-target lesions as well as considering the occurrence of new lesions. The best overall response (RECIST) was chosen for each patient out of all valid tumour assessments before start of next-line therapy (complete response=CR being the best and progressive disease=PD the worst). Frequencies with percentages were to be given for each category (CR, partial response (PR), stable disease (SD), PD) by treatment group. The data were to be presented as the dichotomous endpoint of objective response, for which patients with best overall response of CR or PR were considered as responders, and those with best overall response of SD or PD as non-responders. The difference between objective response rates in the two treatment arms was to be compared with a Chi-square test.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Number of Participants Who Achieved at Least Partial Response (Responders)
responders
|
26 Participants
|
25 Participants
|
|
Number of Participants Who Achieved at Least Partial Response (Responders)
non-responders
|
6 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 1 yearLoco-regional failure was defined as progressive primary tumor and/or regional lymph nodes on endoscopy, endoscopic ultrasound or computed tomography.Time to event was referenced from the day of randomization.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive Without Loco-regional Failure at 1 Year
|
89 percentage of participants
Interval 77.0 to 100.0
|
81 percentage of participants
Interval 67.0 to 95.0
|
SECONDARY outcome
Timeframe: 2 yearsLoco-regional failure was defined as progressive primary tumor and/or regional lymph nodes on endoscopy, endoscopic ultrasound or computed tomography. Time to event was referenced from the day of randomization.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Rate of Participants Who Were Alive Without Loco-regional Failure at 2 Years
|
84 percentage of participants
Interval 70.0 to 99.0
|
72 percentage of participants
Interval 55.0 to 89.0
|
SECONDARY outcome
Timeframe: end of treatment (after 5 to 13 weeks)Population: All scales used for the rows below in the outcome measure data table ranged between 0 and 100. For scales indicated \[H\], a higher score represents a better situation (quality of life, functioning). For scales indicated \[L\], a lower value represents a better outcome (symptoms/problems).
Quality of Life was assessed with EORTC QLQ-C30 and QLQ-OES18 questionnaires. For QLQ-C30, global health status, functional scales (physical, role, emotional, cognitive and social functioning) and symptom scales (fatigue, nausea/vomiting, pain, dyspnea, loss of appetite, constipation, diarrhea, financial difficulties) were calculated. Scores ranged from 0 to 100; higher scores represented higher levels of quality of life, functioning, or symptoms/problems. Score were calculated using mean values. For QLQ-OES18, symptom scales (problems with eating, reflux, pain, problems swallowing saliva, dry mouth, taste disorders, problems while coughing or speaking) and functional scale (dysphagia) were assessed the same way. A change between two time points, i.e. baseline (prior to treatment) and end of treatment (after 5 to 13 weeks, depending on treatment arm (6.5 weeks without and 13 weeks with cetuximab) and achievement of resectability (end of treatment after 5 weeks), is reported.
Outcome measures
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=23 Participants
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=26 Participants
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding problems while coughing [L]
|
-1.4 score on a scale
Standard Deviation 34.05
|
15.9 score on a scale
Standard Deviation 28.19
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Dysphagia [H]
|
-10.1 score on a scale
Standard Deviation 33.41
|
0.0 score on a scale
Standard Deviation 35.93
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change in global health status [H]
|
-9.1 score on a scale
Standard Deviation 23.96
|
-4.7 score on a scale
Standard Deviation 33.41
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change in physical functioning [H]
|
-19.2 score on a scale
Standard Deviation 27.34
|
-13.0 score on a scale
Standard Deviation 24.66
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change in role functioning [H]
|
-22.0 score on a scale
Standard Deviation 32.69
|
-18.1 score on a scale
Standard Deviation 28.39
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change in emotional functioning [H]
|
-9.4 score on a scale
Standard Deviation 25.54
|
3.4 score on a scale
Standard Deviation 27.52
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change in cognitive functioning [H]
|
-13.8 score on a scale
Standard Deviation 24.95
|
-7.2 score on a scale
Standard Deviation 21.80
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change in social functioning [H]
|
-12.1 score on a scale
Standard Deviation 37.86
|
-3.6 score on a scale
Standard Deviation 42.03
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding fatigue [L]
|
21.7 score on a scale
Standard Deviation 24.50
|
15.5 score on a scale
Standard Deviation 33.92
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding nausea/vomiting [L]
|
23.2 score on a scale
Standard Deviation 30.46
|
21.7 score on a scale
Standard Deviation 29.06
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding pain [L]
|
-2.2 score on a scale
Standard Deviation 27.66
|
2.1 score on a scale
Standard Deviation 37.85
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding dyspnoea [L]
|
10.1 score on a scale
Standard Deviation 23.43
|
11.6 score on a scale
Standard Deviation 39.71
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding insomnia [L]
|
-10.1 score on a scale
Standard Deviation 35.44
|
14.5 score on a scale
Standard Deviation 41.23
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding loss of appetite [L]
|
23.2 score on a scale
Standard Deviation 43.15
|
31.9 score on a scale
Standard Deviation 50.73
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding constipation [L]
|
13.0 score on a scale
Standard Deviation 29.71
|
-1.4 score on a scale
Standard Deviation 39.54
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding diarrhea [L]
|
15.2 score on a scale
Standard Deviation 24.62
|
2.9 score on a scale
Standard Deviation 19.88
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding financial difficulties [L]
|
0.0 score on a scale
Standard Deviation 36.24
|
-5.8 score on a scale
Standard Deviation 38.47
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding problems with eating [L]
|
4.0 score on a scale
Standard Deviation 34.07
|
1.9 score on a scale
Standard Deviation 36.20
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding reflux [L]
|
11.6 score on a scale
Standard Deviation 28.62
|
-1.4 score on a scale
Standard Deviation 35.86
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding pain while eating [L]
|
2.9 score on a scale
Standard Deviation 18.42
|
-6.5 score on a scale
Standard Deviation 35.24
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding problems swallowing saliva [L]
|
-2.9 score on a scale
Standard Deviation 41.33
|
4.3 score on a scale
Standard Deviation 30.66
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding dry mouth [L]
|
21.7 score on a scale
Standard Deviation 38.41
|
1.5 score on a scale
Standard Deviation 41.76
|
|
Change in Quality of Life Between Baseline and End of Treatment (After 5 to 13 Weeks)
Change regarding taste disorders [L]
|
33.3 score on a scale
Standard Deviation 46.06
|
27.3 score on a scale
Standard Deviation 39.36
|
Adverse Events
Cetuximab, Cisplatin, 5-FU, Radiotherapy
Serious events: 21 serious events
Other events: 32 other events
Deaths: 13 deaths
Cisplatin, 5-FU, Radiotherapy
Serious events: 24 serious events
Other events: 36 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 participants at risk
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 participants at risk
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
9.4%
3/32 • Number of events 3 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
25.0%
9/36 • Number of events 11 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Esophagitis
|
18.8%
6/32 • Number of events 7 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
13.9%
5/36 • Number of events 5 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
White blood cell decreased
|
9.4%
3/32 • Number of events 3 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Vascular disorders
Thromboembolic event
|
6.2%
2/32 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
2/32 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • Number of events 5 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hypokalemia (low potassium)
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Sepsis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Stoma site infection
|
6.2%
2/32 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 3 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Blood and lymphatic system disorders
Anemia
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
Liver enzymes increased/elevated
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • Number of events 3 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Immune system disorders
Allergic reaction
|
6.2%
2/32 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Infection (not specified)
|
6.2%
2/32 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
Pancytopenia
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Cardiac disorders
Ventricular tachycardia
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Gastric ulcer
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Hematemesis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Death (not specified)
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Fatigue
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Fever
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Immune system disorders
Immune system disorder (not specified)
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Appendicitis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Device related infection
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Abdominal infection
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Enterocilitis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Nail infection
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Skin infection
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Wound infection
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Fistula
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Injury, poisoning and procedural complications
Morphine overdose
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Injury, poisoning and procedural complications
Tumor bleeding
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Injury, poisoning and procedural complications
Doslocation of feeding tube (PEG)
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Acidosis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Alcalosis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Dehydration/Exsiccosis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Nervous system disorders
Cognitive disturbance
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Nervous system disorders
Seizure
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Nervous system disorders
Stroke
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Renal and urinary disorders
renal failure
|
6.2%
2/32 • Number of events 2 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • Number of events 3 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Renal and urinary disorders
Nephrotoxicity, tubular function impaired
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fistula
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Skin and subcutaneous tissue disorders
Palma-plantar erythrodysesthesia syndrome
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Skin and subcutaneous tissue disorders
Acneiforme rash
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Reduced overall health condition
|
3.1%
1/32 • Number of events 1 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
Other adverse events
| Measure |
Cetuximab, Cisplatin, 5-FU, Radiotherapy
n=32 participants at risk
Cetuximab: Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total, IV
5-FU: 1000mg/m2 per day as continuous infusion on day 8-11 and 36-39, 750mg/m2/day as continuous infusion on day 71-74 and 99-102
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 8-11, 36-39, 71-74 and 99-102)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
Cisplatin, 5-FU, Radiotherapy
n=36 participants at risk
5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 and 29-32, 750mg/m2/day as continuous infusion on day 64-67 and 92-95
Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle (day 1-4, 29-32, 64-67 and 92-95)
radiotherapy: 59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
59.4%
19/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
55.6%
20/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hypokalemia (low potassium)
|
50.0%
16/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
33.3%
12/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Blood and lymphatic system disorders
Anemia
|
40.6%
13/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
36.1%
13/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Fatigue
|
28.1%
9/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
50.0%
18/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Esophagitis
|
34.4%
11/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
38.9%
14/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
White blood cell decreased
|
50.0%
16/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
22.2%
8/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Dysphagia
|
28.1%
9/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
25.0%
9/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
Platelet count decreased
|
34.4%
11/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
19.4%
7/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
30.6%
11/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
40.6%
13/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Vomiting
|
18.8%
6/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
19.4%
7/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
9.4%
3/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
25.0%
9/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Diarrhea
|
21.9%
7/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
13.9%
5/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Oral mucositis
|
25.0%
8/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
11.1%
4/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Weight loss
|
28.1%
9/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.6%
5/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
19.4%
7/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
28.1%
9/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Skin and subcutaneous tissue disorders
Acneiforme rash
|
34.4%
11/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
28.1%
9/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Edema
|
18.8%
6/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
11.1%
4/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
Neutrophil count decreased
|
15.6%
5/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
11.1%
4/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Nervous system disorders
Dizziness
|
15.6%
5/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
3/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
13.9%
5/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
21.9%
7/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Pain
|
15.6%
5/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Nervous system disorders
Insomnia
|
6.2%
2/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
13.9%
5/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.5%
4/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
1/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
13.9%
5/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Investigations
GGT increased
|
9.4%
3/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Infection (not specified)
|
9.4%
3/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Nervous system disorders
Paresthesia
|
3.1%
1/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
11.1%
4/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Vascular disorders
Thrombembolic event
|
6.2%
2/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Immune system disorders
Allergic reaction
|
12.5%
4/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
0.00%
0/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
2/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Infections and infestations
Stoma site infection
|
9.4%
3/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
2.8%
1/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Metabolism and nutrition disorders
Hyponatremia (low sodium)
|
3.1%
1/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
8.3%
3/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
General disorders
Weight gain
|
0.00%
0/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
11.1%
4/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Nervous system disorders
Syncope
|
6.2%
2/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Renal and urinary disorders
Urinary retention
|
6.2%
2/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
|
Gastrointestinal disorders
Esophageal pain
|
6.2%
2/32 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
5.6%
2/36 • 2 years
Common Terminology Criteria for Adverse Events (CTCAE), version 4.03
|
Additional Information
Prof. Dr. med. Dirk Rades
Department of Radiation Oncology, University of Lübeck, Germany
Phone: 0049 451 500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications (presentation of results obtained at a participating center at scientific meetings or publication of these results) prior to public release and can embargo communications regarding trial results prior to submission of the results of the entire study for publication.
- Publication restrictions are in place
Restriction type: OTHER