Trial Outcomes & Findings for Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients (NCT NCT01268943)
NCT ID: NCT01268943
Last Updated: 2015-04-06
Results Overview
dose related toxicity is defined as follows:1. WBC damage \>= grade 3; granular cell decrease \>= grade 3; hemoglobin \>= grade 2; platelet \>= grade 2;SGPT/SGOT elevation \>= grade 2; ALP \>= grade 2; GGT \>= grade 2; Tbil \>= grade 2;renal function damage: BUN/Cr elevation \>= grade 2;Non-gradular cell decreased fever \>= grade 2;nausea/vomiting \>= grade 2; fatigue \>= grade 3; weight loss \>= grade 3;gastritis \>= grade 3; dairrea \>= grade 3; abdominal pain \>= grade 3; pancreatitis \>= grade 2; upper gastrointestinal bleeding \>= grade 2;other toxic reaction \>= grade 3;KPS \< 50 during the treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
up to 9 weeks
Results posted on
2015-04-06
Participant Flow
Between October 2010 and November 2013, 18 patients were enrolled in a hospital.
Participant milestones
| Measure |
1000mg
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1200mg
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1400mg
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1500mg
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Postoperative Concurrent Chemo-radiation With Capecitabine in Elderly Rectal Cancer Patients
Baseline characteristics by cohort
| Measure |
1000mg
n=6 Participants
capecitabine 500mg/m2 twice daily. 6 patients enrolled
|
1200mg
n=3 Participants
capecitabine 600mg/m2 twice daily. 3 patients enrolled
|
1400mg
n=3 Participants
capecitabine 700mg/m2 twice daily. 3 patients enrolled
|
1500mg
n=6 Participants
capecitabine 750mg/m2 twice daily. 6 patients enrolled
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Continuous
|
75.5 years
n=5 Participants
|
73.7 years
n=7 Participants
|
75.7 years
n=5 Participants
|
73.5 years
n=4 Participants
|
74.5 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: up to 9 weeksdose related toxicity is defined as follows:1. WBC damage \>= grade 3; granular cell decrease \>= grade 3; hemoglobin \>= grade 2; platelet \>= grade 2;SGPT/SGOT elevation \>= grade 2; ALP \>= grade 2; GGT \>= grade 2; Tbil \>= grade 2;renal function damage: BUN/Cr elevation \>= grade 2;Non-gradular cell decreased fever \>= grade 2;nausea/vomiting \>= grade 2; fatigue \>= grade 3; weight loss \>= grade 3;gastritis \>= grade 3; dairrea \>= grade 3; abdominal pain \>= grade 3; pancreatitis \>= grade 2; upper gastrointestinal bleeding \>= grade 2;other toxic reaction \>= grade 3;KPS \< 50 during the treatment
Outcome measures
| Measure |
1000mg
n=6 Participants
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1200mg
n=3 Participants
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1400mg
n=3 Participants
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1500mg
n=6 Participants
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
|---|---|---|---|---|
|
Dose Related Toxicity
|
1 event
|
0 event
|
0 event
|
3 event
|
Adverse Events
1000mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
1200mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
1400mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1500mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1000mg
n=6 participants at risk
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1200mg
n=3 participants at risk
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1400mg
n=3 participants at risk
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1500mg
n=6 participants at risk
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea, grade 3
|
16.7%
1/6 • Number of events 1 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
16.7%
1/6 • Number of events 1 • 9 weeks
|
|
Gastrointestinal disorders
vomiting, grade 3
|
0.00%
0/6 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
16.7%
1/6 • Number of events 1 • 9 weeks
|
|
Blood and lymphatic system disorders
leukopenia, grade 3
|
0.00%
0/6 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
16.7%
1/6 • Number of events 1 • 9 weeks
|
Other adverse events
| Measure |
1000mg
n=6 participants at risk
capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1200mg
n=3 participants at risk
capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1400mg
n=3 participants at risk
capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
1500mg
n=6 participants at risk
capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
|
|---|---|---|---|---|
|
General disorders
fatigue
|
66.7%
4/6 • Number of events 4 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
50.0%
3/6 • Number of events 3 • 9 weeks
|
|
General disorders
anorexia
|
50.0%
3/6 • Number of events 3 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
50.0%
3/6 • Number of events 3 • 9 weeks
|
|
Gastrointestinal disorders
vomiting, grade 1-2
|
0.00%
0/6 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
33.3%
1/3 • Number of events 1 • 9 weeks
|
0.00%
0/6 • 9 weeks
|
|
Gastrointestinal disorders
diarrhea, grade 1-2
|
50.0%
3/6 • Number of events 3 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
33.3%
1/3 • Number of events 1 • 9 weeks
|
33.3%
2/6 • Number of events 2 • 9 weeks
|
|
Gastrointestinal disorders
incontinence
|
50.0%
3/6 • Number of events 3 • 9 weeks
|
33.3%
1/3 • Number of events 1 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
16.7%
1/6 • Number of events 1 • 9 weeks
|
|
Gastrointestinal disorders
abodminal pain
|
50.0%
3/6 • Number of events 3 • 9 weeks
|
33.3%
1/3 • Number of events 1 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
16.7%
1/6 • Number of events 1 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
skin reation
|
66.7%
4/6 • Number of events 4 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
33.3%
2/6 • Number of events 2 • 9 weeks
|
|
Skin and subcutaneous tissue disorders
hand-foot syndrome
|
0.00%
0/6 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
33.3%
1/3 • Number of events 1 • 9 weeks
|
0.00%
0/6 • 9 weeks
|
|
Blood and lymphatic system disorders
leukopenia, grade 1-2
|
83.3%
5/6 • Number of events 5 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
66.7%
2/3 • Number of events 2 • 9 weeks
|
66.7%
4/6 • Number of events 4 • 9 weeks
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/6 • 9 weeks
|
0.00%
0/3 • 9 weeks
|
33.3%
1/3 • Number of events 1 • 9 weeks
|
0.00%
0/6 • 9 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place