Trial Outcomes & Findings for Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer (NCT NCT01584544)
NCT ID: NCT01584544
Last Updated: 2015-04-20
Results Overview
Dose related toxicity is defined as follows:1. luecopenia \> grade 2; granular cell decrease \> grade 2; anemia \> grade 1; platelet \> grade 1;SGPT/SGOT elevation \> grade 1; ALP \> grade 1; GGT \> grade 1; Tbil \> grade 1;renal function damag \> grade 2;Non-gradular cell decreased fever \> grade 1;nausea/vomiting \> grade 1; fatigue \> grade 2; weight loss \> grade 2;gastritis \> grade 2; dairrea \> grade 2; abdominal pain \> grade 2; upper gastrointestinal bleeding \> grade 1;other toxic reaction \> grade 2;KPS \< 50 during the treatment
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
up to 7 weeks from start of the treatment
Results posted on
2015-04-20
Participant Flow
Participant milestones
| Measure |
1000mg
capecitabine 1000mg/m2/d d1-14, d22-25 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
|
1350mg
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/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
|
1650mg
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
6
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
6
|
6
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Capecitabine With Radiation in Elderly Rectal Cancer
Baseline characteristics by cohort
| Measure |
1000mg
n=3 Participants
capecitabine 1000mg/m2/d d1-14, d22-25 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=6 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
|
1350mg
n=6 Participants
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
1500mg
n=3 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
|
1650mg
n=6 Participants
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
Total
n=24 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
|
0 Participants
n=8 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
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Age, Continuous
|
77 years
n=5 Participants
|
77 years
n=7 Participants
|
78 years
n=5 Participants
|
76 years
n=4 Participants
|
78 years
n=21 Participants
|
78 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Region of Enrollment
China
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
3 participants
n=4 Participants
|
6 participants
n=21 Participants
|
24 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: up to 7 weeks from start of the treatmentDose related toxicity is defined as follows:1. luecopenia \> grade 2; granular cell decrease \> grade 2; anemia \> grade 1; platelet \> grade 1;SGPT/SGOT elevation \> grade 1; ALP \> grade 1; GGT \> grade 1; Tbil \> grade 1;renal function damag \> grade 2;Non-gradular cell decreased fever \> grade 1;nausea/vomiting \> grade 1; fatigue \> grade 2; weight loss \> grade 2;gastritis \> grade 2; dairrea \> grade 2; abdominal pain \> grade 2; upper gastrointestinal bleeding \> grade 1;other toxic reaction \> grade 2;KPS \< 50 during the treatment
Outcome measures
| Measure |
1000mg
n=3 Participants
capecitabine 1000mg/m2/d d1-14, d22-25 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=6 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
|
1350mg
n=6 Participants
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
1500mg
n=3 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
|
1650mg
n=6 Participants
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
|---|---|---|---|---|---|
|
Number of Participants Experienced Dose Limited Toxicity
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
Adverse Events
1000mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1200mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
1350mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
1500mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
1650mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1000mg
n=3 participants at risk
capecitabine 1000mg/m2/d d1-14, d22-25 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=6 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
|
1350mg
n=6 participants at risk
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
1500mg
n=3 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
|
1650mg
n=6 participants at risk
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea, Grade 3
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
|
Infections and infestations
Lung infection, Grade 3
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
Gastrointestinal disorders
Proctitis, Grade 3
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
Infections and infestations
Fever, Grade 3
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
General disorders
Fatigue, Grade 3
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
|
General disorders
Pain, Grade 3
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
|
Gastrointestinal disorders
Nausea, Grade 3
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
Other adverse events
| Measure |
1000mg
n=3 participants at risk
capecitabine 1000mg/m2/d d1-14, d22-25 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=6 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
|
1350mg
n=6 participants at risk
capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
1500mg
n=3 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
|
1650mg
n=6 participants at risk
capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.
Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
100.0%
3/3 • 7 weeks after treatment started
|
100.0%
6/6 • 7 weeks after treatment started
|
83.3%
5/6 • 7 weeks after treatment started
|
100.0%
3/3 • 7 weeks after treatment started
|
33.3%
2/6 • 7 weeks after treatment started
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • 7 weeks after treatment started
|
83.3%
5/6 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
33.3%
1/3 • 7 weeks after treatment started
|
50.0%
3/6 • 7 weeks after treatment started
|
|
General disorders
Fatigue
|
66.7%
2/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
33.3%
2/6 • 7 weeks after treatment started
|
66.7%
2/3 • 7 weeks after treatment started
|
33.3%
2/6 • 7 weeks after treatment started
|
|
General disorders
Pain
|
0.00%
0/3 • 7 weeks after treatment started
|
50.0%
3/6 • 7 weeks after treatment started
|
33.3%
2/6 • 7 weeks after treatment started
|
33.3%
1/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
50.0%
3/6 • 7 weeks after treatment started
|
66.7%
2/3 • 7 weeks after treatment started
|
50.0%
3/6 • 7 weeks after treatment started
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
33.3%
1/3 • 7 weeks after treatment started
|
50.0%
3/6 • 7 weeks after treatment started
|
|
Gastrointestinal disorders
Proctitis
|
33.3%
1/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
Infections and infestations
Fever
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
Blood and lymphatic system disorders
Leukopenia
|
66.7%
2/3 • 7 weeks after treatment started
|
66.7%
4/6 • 7 weeks after treatment started
|
83.3%
5/6 • 7 weeks after treatment started
|
66.7%
2/3 • 7 weeks after treatment started
|
33.3%
2/6 • 7 weeks after treatment started
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
33.3%
2/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
|
Nervous system disorders
Hand-foot syndrome
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
33.3%
1/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
General disorders
Weight loss
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/6 • 7 weeks after treatment started
|
0.00%
0/3 • 7 weeks after treatment started
|
16.7%
1/6 • 7 weeks after treatment started
|
Additional Information
Dr. Jing Jin
Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Phone: 8601087788122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place