Trial Outcomes & Findings for S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction (NCT NCT02270450)
NCT ID: NCT02270450
Last Updated: 2023-03-30
Results Overview
Number of days alive and outside of the hospital
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
221 participants
Primary outcome timeframe
From date of registration up to 91 days
Results posted on
2023-03-30
Participant Flow
221 patients were initially enrolled. 19 were ineligible: 12 with no small bowel obstruction, 3 with no confirmed bowel obstruction, 3 who were treated prior to registration and 1 with no intra-abdominal cancer. Another 3 patients were ineligible for analysis, due to withdrawal of consent prior to the end of their first hospitalization. In all, 199 patients were treated and evaluable for analysis: 49 randomized (24 surgery; 25 non-surgery) and 150 non-randomized (58 surgery; 92 non-surgery).
Participant milestones
| Measure |
Arm I (Randomized to Surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
therapeutic conventional surgery: Undergo abdominal surgery
quality-of-life assessment: Ancillary studies
|
Arm II (Randomized to Non-surgical Management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
gastrointestinal complications management/prevention: Undergo non-surgical management
quality-of-life assessment: Ancillary studies
|
Arm III (no Randomization, Surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
therapeutic conventional surgery: Undergo abdominal surgery
quality-of-life assessment: Ancillary studies
|
Arm IV (no Randomization, Non-surgical Management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.
gastrointestinal complications management/prevention: Undergo non-surgical management
quality-of-life assessment: Ancillary studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
58
|
92
|
|
Overall Study
COMPLETED
|
1
|
3
|
18
|
10
|
|
Overall Study
NOT COMPLETED
|
23
|
22
|
40
|
82
|
Reasons for withdrawal
| Measure |
Arm I (Randomized to Surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
therapeutic conventional surgery: Undergo abdominal surgery
quality-of-life assessment: Ancillary studies
|
Arm II (Randomized to Non-surgical Management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
gastrointestinal complications management/prevention: Undergo non-surgical management
quality-of-life assessment: Ancillary studies
|
Arm III (no Randomization, Surgery)
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
therapeutic conventional surgery: Undergo abdominal surgery
quality-of-life assessment: Ancillary studies
|
Arm IV (no Randomization, Non-surgical Management)
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.
gastrointestinal complications management/prevention: Undergo non-surgical management
quality-of-life assessment: Ancillary studies
|
|---|---|---|---|---|
|
Overall Study
Refusal unrelated to adverse event
|
3
|
1
|
5
|
14
|
|
Overall Study
Progression/relapse
|
1
|
2
|
4
|
9
|
|
Overall Study
Death
|
19
|
19
|
31
|
59
|
Baseline Characteristics
Race was not applicable for participants from Mexico and Peru.
Baseline characteristics by cohort
| Measure |
Arm I (Randomized to Surgery)
n=24 Participants
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
therapeutic conventional surgery: Undergo abdominal surgery
quality-of-life assessment: Ancillary studies
|
Arm II (Randomized to Non-surgical Management)
n=25 Participants
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
gastrointestinal complications management/prevention: Undergo non-surgical management
quality-of-life assessment: Ancillary studies
|
Arm III (no Randomization, Surgery)
n=58 Participants
Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
therapeutic conventional surgery: Undergo abdominal surgery
quality-of-life assessment: Ancillary studies
|
Arm IV (no Randomization, Non-surgical Management)
n=92 Participants
Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II.
gastrointestinal complications management/prevention: Undergo non-surgical management
quality-of-life assessment: Ancillary studies
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.4 years
n=24 Participants
|
61.2 years
n=25 Participants
|
61.1 years
n=58 Participants
|
59.3 years
n=92 Participants
|
60.4 years
n=199 Participants
|
|
Age, Customized
< 65 years
|
13 Participants
n=24 Participants
|
17 Participants
n=25 Participants
|
36 Participants
n=58 Participants
|
65 Participants
n=92 Participants
|
131 Participants
n=199 Participants
|
|
Age, Customized
>= 65 years
|
11 Participants
n=24 Participants
|
8 Participants
n=25 Participants
|
22 Participants
n=58 Participants
|
27 Participants
n=92 Participants
|
68 Participants
n=199 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=24 Participants
|
15 Participants
n=25 Participants
|
36 Participants
n=58 Participants
|
62 Participants
n=92 Participants
|
129 Participants
n=199 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=24 Participants
|
10 Participants
n=25 Participants
|
22 Participants
n=58 Participants
|
30 Participants
n=92 Participants
|
70 Participants
n=199 Participants
|
|
Race/Ethnicity, Customized
Race - Black
|
6 Participants
n=16 Participants • Race was not applicable for participants from Mexico and Peru.
|
7 Participants
n=20 Participants • Race was not applicable for participants from Mexico and Peru.
|
13 Participants
n=58 Participants • Race was not applicable for participants from Mexico and Peru.
|
16 Participants
n=92 Participants • Race was not applicable for participants from Mexico and Peru.
|
42 Participants
n=186 Participants • Race was not applicable for participants from Mexico and Peru.
|
|
Race/Ethnicity, Customized
Race - White
|
9 Participants
n=16 Participants • Race was not applicable for participants from Mexico and Peru.
|
12 Participants
n=20 Participants • Race was not applicable for participants from Mexico and Peru.
|
39 Participants
n=58 Participants • Race was not applicable for participants from Mexico and Peru.
|
69 Participants
n=92 Participants • Race was not applicable for participants from Mexico and Peru.
|
129 Participants
n=186 Participants • Race was not applicable for participants from Mexico and Peru.
|
|
Race/Ethnicity, Customized
Race - Other
|
1 Participants
n=16 Participants • Race was not applicable for participants from Mexico and Peru.
|
1 Participants
n=20 Participants • Race was not applicable for participants from Mexico and Peru.
|
1 Participants
n=58 Participants • Race was not applicable for participants from Mexico and Peru.
|
3 Participants
n=92 Participants • Race was not applicable for participants from Mexico and Peru.
|
6 Participants
n=186 Participants • Race was not applicable for participants from Mexico and Peru.
|
|
Race/Ethnicity, Customized
Race - Unknown
|
0 Participants
n=16 Participants • Race was not applicable for participants from Mexico and Peru.
|
0 Participants
n=20 Participants • Race was not applicable for participants from Mexico and Peru.
|
5 Participants
n=58 Participants • Race was not applicable for participants from Mexico and Peru.
|
4 Participants
n=92 Participants • Race was not applicable for participants from Mexico and Peru.
|
9 Participants
n=186 Participants • Race was not applicable for participants from Mexico and Peru.
|
|
Race/Ethnicity, Customized
Ethnicity - Hispanic
|
9 Participants
n=24 Participants • Race was not applicable for participants from Mexico and Peru.
|
5 Participants
n=25 Participants • Race was not applicable for participants from Mexico and Peru.
|
6 Participants
n=58 Participants • Race was not applicable for participants from Mexico and Peru.
|
13 Participants
n=92 Participants • Race was not applicable for participants from Mexico and Peru.
|
33 Participants
n=199 Participants • Race was not applicable for participants from Mexico and Peru.
|
|
Race/Ethnicity, Customized
Ethnicity - Non-Hispanic
|
14 Participants
n=24 Participants • Race was not applicable for participants from Mexico and Peru.
|
18 Participants
n=25 Participants • Race was not applicable for participants from Mexico and Peru.
|
51 Participants
n=58 Participants • Race was not applicable for participants from Mexico and Peru.
|
78 Participants
n=92 Participants • Race was not applicable for participants from Mexico and Peru.
|
161 Participants
n=199 Participants • Race was not applicable for participants from Mexico and Peru.
|
|
Race/Ethnicity, Customized
Ethnicity - Unknown
|
1 Participants
n=24 Participants • Race was not applicable for participants from Mexico and Peru.
|
2 Participants
n=25 Participants • Race was not applicable for participants from Mexico and Peru.
|
1 Participants
n=58 Participants • Race was not applicable for participants from Mexico and Peru.
|
1 Participants
n=92 Participants • Race was not applicable for participants from Mexico and Peru.
|
5 Participants
n=199 Participants • Race was not applicable for participants from Mexico and Peru.
|
|
Primary Cancer Site
Colorectal
|
6 Participants
n=24 Participants
|
7 Participants
n=25 Participants
|
19 Participants
n=58 Participants
|
25 Participants
n=92 Participants
|
57 Participants
n=199 Participants
|
|
Primary Cancer Site
Gynecologic
|
10 Participants
n=24 Participants
|
12 Participants
n=25 Participants
|
14 Participants
n=58 Participants
|
38 Participants
n=92 Participants
|
74 Participants
n=199 Participants
|
|
Primary Cancer Site
Other
|
8 Participants
n=24 Participants
|
6 Participants
n=25 Participants
|
25 Participants
n=58 Participants
|
29 Participants
n=92 Participants
|
68 Participants
n=199 Participants
|
|
Body Mass Index (BMI), Continuous
|
23.8 kg/m^2
n=24 Participants
|
25.7 kg/m^2
n=25 Participants
|
24.4 kg/m^2
n=58 Participants
|
24.7 kg/m^2
n=92 Participants
|
24.6 kg/m^2
n=199 Participants
|
|
Body Mass Index (BMI), Categorical
<18.5 (Underweight)
|
3 Participants
n=24 Participants
|
2 Participants
n=25 Participants
|
7 Participants
n=58 Participants
|
6 Participants
n=92 Participants
|
18 Participants
n=199 Participants
|
|
Body Mass Index (BMI), Categorical
18.5 - <25 (Normal)
|
10 Participants
n=24 Participants
|
10 Participants
n=25 Participants
|
26 Participants
n=58 Participants
|
45 Participants
n=92 Participants
|
91 Participants
n=199 Participants
|
|
Body Mass Index (BMI), Categorical
25 - <30 (Overweight)
|
6 Participants
n=24 Participants
|
7 Participants
n=25 Participants
|
12 Participants
n=58 Participants
|
20 Participants
n=92 Participants
|
45 Participants
n=199 Participants
|
|
Body Mass Index (BMI), Categorical
>=30 (Obese)
|
5 Participants
n=24 Participants
|
6 Participants
n=25 Participants
|
13 Participants
n=58 Participants
|
21 Participants
n=92 Participants
|
45 Participants
n=199 Participants
|
|
Albumin, Continuous
|
3.1 g/dL
STANDARD_DEVIATION 0.9 • n=24 Participants • Number of participants analyzed differs from overall number of baseline participants due to missing data.
|
3.1 g/dL
STANDARD_DEVIATION 0.7 • n=25 Participants • Number of participants analyzed differs from overall number of baseline participants due to missing data.
|
3.2 g/dL
STANDARD_DEVIATION 0.7 • n=58 Participants • Number of participants analyzed differs from overall number of baseline participants due to missing data.
|
3.2 g/dL
STANDARD_DEVIATION 0.7 • n=91 Participants • Number of participants analyzed differs from overall number of baseline participants due to missing data.
|
3.2 g/dL
STANDARD_DEVIATION 0.7 • n=198 Participants • Number of participants analyzed differs from overall number of baseline participants due to missing data.
|
|
Albumin, Child-Pugh
<2.8
|
7 Participants
n=24 Participants
|
7 Participants
n=25 Participants
|
18 Participants
n=58 Participants
|
25 Participants
n=92 Participants
|
57 Participants
n=199 Participants
|
|
Albumin, Child-Pugh
2.8 - 3.5
|
9 Participants
n=24 Participants
|
11 Participants
n=25 Participants
|
20 Participants
n=58 Participants
|
35 Participants
n=92 Participants
|
75 Participants
n=199 Participants
|
|
Albumin, Child-Pugh
>3.5
|
8 Participants
n=24 Participants
|
7 Participants
n=25 Participants
|
20 Participants
n=58 Participants
|
31 Participants
n=92 Participants
|
66 Participants
n=199 Participants
|
|
Albumin, Child-Pugh
Missing
|
0 Participants
n=24 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=58 Participants
|
1 Participants
n=92 Participants
|
1 Participants
n=199 Participants
|
|
Ascites
No evidence
|
8 Participants
n=24 Participants
|
12 Participants
n=25 Participants
|
26 Participants
n=58 Participants
|
43 Participants
n=92 Participants
|
89 Participants
n=199 Participants
|
|
Ascites
Evidence of ascites: trace/small amount
|
11 Participants
n=24 Participants
|
7 Participants
n=25 Participants
|
24 Participants
n=58 Participants
|
29 Participants
n=92 Participants
|
71 Participants
n=199 Participants
|
|
Ascites
Evidence of ascites: large/massive amount
|
5 Participants
n=24 Participants
|
6 Participants
n=25 Participants
|
8 Participants
n=58 Participants
|
20 Participants
n=92 Participants
|
39 Participants
n=199 Participants
|
|
Carcinomatosis
No evidence
|
6 Participants
n=24 Participants
|
5 Participants
n=25 Participants
|
25 Participants
n=58 Participants
|
31 Participants
n=92 Participants
|
67 Participants
n=199 Participants
|
|
Carcinomatosis
Suspicion of carcinomatosis
|
2 Participants
n=24 Participants
|
2 Participants
n=25 Participants
|
4 Participants
n=58 Participants
|
8 Participants
n=92 Participants
|
16 Participants
n=199 Participants
|
|
Carcinomatosis
Clear evidence: trace/small amount
|
2 Participants
n=24 Participants
|
4 Participants
n=25 Participants
|
3 Participants
n=58 Participants
|
0 Participants
n=92 Participants
|
9 Participants
n=199 Participants
|
|
Carcinomatosis
Clear evidence: large/massive amount
|
14 Participants
n=24 Participants
|
14 Participants
n=25 Participants
|
26 Participants
n=58 Participants
|
53 Participants
n=92 Participants
|
107 Participants
n=199 Participants
|
|
Performance Status
0
|
8 Participants
n=24 Participants
|
5 Participants
n=25 Participants
|
9 Participants
n=58 Participants
|
15 Participants
n=92 Participants
|
37 Participants
n=199 Participants
|
|
Performance Status
1
|
6 Participants
n=24 Participants
|
9 Participants
n=25 Participants
|
29 Participants
n=58 Participants
|
50 Participants
n=92 Participants
|
94 Participants
n=199 Participants
|
|
Performance Status
2
|
10 Participants
n=24 Participants
|
11 Participants
n=25 Participants
|
20 Participants
n=58 Participants
|
27 Participants
n=92 Participants
|
68 Participants
n=199 Participants
|
|
Number of Prior Malignant Bowel Obstructions (MBOs)
None
|
17 Participants
n=24 Participants
|
16 Participants
n=25 Participants
|
32 Participants
n=58 Participants
|
51 Participants
n=92 Participants
|
116 Participants
n=199 Participants
|
|
Number of Prior Malignant Bowel Obstructions (MBOs)
At least one
|
5 Participants
n=24 Participants
|
4 Participants
n=25 Participants
|
21 Participants
n=58 Participants
|
31 Participants
n=92 Participants
|
61 Participants
n=199 Participants
|
|
Number of Prior Malignant Bowel Obstructions (MBOs)
Unknown
|
2 Participants
n=24 Participants
|
4 Participants
n=25 Participants
|
4 Participants
n=58 Participants
|
9 Participants
n=92 Participants
|
19 Participants
n=199 Participants
|
|
Number of Prior Malignant Bowel Obstructions (MBOs)
Missing
|
0 Participants
n=24 Participants
|
1 Participants
n=25 Participants
|
1 Participants
n=58 Participants
|
1 Participants
n=92 Participants
|
3 Participants
n=199 Participants
|
|
Care Providers
Family member
|
22 Participants
n=24 Participants
|
21 Participants
n=25 Participants
|
51 Participants
n=58 Participants
|
77 Participants
n=92 Participants
|
171 Participants
n=199 Participants
|
|
Care Providers
Hospice/Skilled nursing
|
1 Participants
n=24 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=58 Participants
|
6 Participants
n=92 Participants
|
8 Participants
n=199 Participants
|
|
Care Providers
Other
|
0 Participants
n=24 Participants
|
2 Participants
n=25 Participants
|
4 Participants
n=58 Participants
|
3 Participants
n=92 Participants
|
9 Participants
n=199 Participants
|
|
Care Providers
No one
|
1 Participants
n=24 Participants
|
2 Participants
n=25 Participants
|
5 Participants
n=58 Participants
|
11 Participants
n=92 Participants
|
19 Participants
n=199 Participants
|
|
Admitting Attending Physician Specialty
Medical Specialty
|
0 Participants
n=24 Participants
|
2 Participants
n=25 Participants
|
4 Participants
n=58 Participants
|
6 Participants
n=92 Participants
|
12 Participants
n=199 Participants
|
|
Admitting Attending Physician Specialty
General Surgery
|
0 Participants
n=24 Participants
|
1 Participants
n=25 Participants
|
10 Participants
n=58 Participants
|
7 Participants
n=92 Participants
|
18 Participants
n=199 Participants
|
|
Admitting Attending Physician Specialty
Gynecologic Oncology
|
3 Participants
n=24 Participants
|
4 Participants
n=25 Participants
|
5 Participants
n=58 Participants
|
30 Participants
n=92 Participants
|
42 Participants
n=199 Participants
|
|
Admitting Attending Physician Specialty
Surgical Oncology
|
20 Participants
n=24 Participants
|
16 Participants
n=25 Participants
|
39 Participants
n=58 Participants
|
49 Participants
n=92 Participants
|
124 Participants
n=199 Participants
|
|
Admitting Attending Physician Specialty
Other
|
1 Participants
n=24 Participants
|
2 Participants
n=25 Participants
|
0 Participants
n=58 Participants
|
0 Participants
n=92 Participants
|
3 Participants
n=199 Participants
|
PRIMARY outcome
Timeframe: From date of registration up to 91 daysPopulation: Eligible and evaluable participants
Number of days alive and outside of the hospital
Outcome measures
| Measure |
Randomization Surgery
n=24 Participants
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=25 Participants
Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=58 Participants
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=92 Participants
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
Number of Days Alive and Outside of the Hospital
|
42.6 days
Standard Deviation 32.2
|
43.9 days
Standard Deviation 29.5
|
54.8 days
Standard Deviation 27.0
|
52.7 days
Standard Deviation 30.7
|
SECONDARY outcome
Timeframe: During initial hospitalization, from date of registration to a maximum of 53 weeks post registrationPopulation: Eligible and evaluable participants
Length of initial hospital stay in days.
Outcome measures
| Measure |
Randomization Surgery
n=24 Participants
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=25 Participants
Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=58 Participants
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=92 Participants
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
Number of Days in Hospital
|
12.3 days
Standard Deviation 9.3
|
12.8 days
Standard Deviation 12.2
|
11.6 days
Standard Deviation 7.8
|
6.2 days
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: During initial hospitalization, from date of registration to a maximum of 53 weeks post registrationPopulation: Eligible and evaluable participants
Use of a nasogastric tube
Outcome measures
| Measure |
Randomization Surgery
n=24 Participants
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=25 Participants
Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=58 Participants
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=92 Participants
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
NG Tube Use
Missing
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
NG Tube Use
Yes
|
19 Participants
|
20 Participants
|
42 Participants
|
69 Participants
|
|
NG Tube Use
No
|
5 Participants
|
5 Participants
|
13 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registrationPopulation: Eligible and evaluable participants. Number of participants analyzed in the Patient Choice Surgery arm and Patient Choice Non-surgical Management arm differs from the overall number of eligible and evaluable participants due to missing data.
Number of days a nasogastric tube was used during the patient's initial hospitalization
Outcome measures
| Measure |
Randomization Surgery
n=24 Participants
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=25 Participants
Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=55 Participants
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=90 Participants
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
Days of NG Tube Use
|
5.8 days
Standard Deviation 4.1
|
7.7 days
Standard Deviation 8.4
|
6.5 days
Standard Deviation 5.6
|
5.1 days
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Assessed at 4 weeks post registrationPopulation: Eligible and evaluable participants who were alive with data at the time of the assessment
The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) was used to assess nausea, vomiting, pain, bloating, and constipation. The MDASI measures symptom severity on an 11-point scale, from 0 ("not present") to 10 ("as bad as you can imagine"). A difference of at least 1.2 points was considered a clinically meaningful difference between groups for MDASI-GI outcomes.
Outcome measures
| Measure |
Randomization Surgery
n=11 Participants
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=11 Participants
Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=31 Participants
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=41 Participants
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
MDASI-GI Symptom Assessment
Nausea Severity
|
0.64 score on a scale
Standard Deviation 1.3
|
4.6 score on a scale
Standard Deviation 3.8
|
1.9 score on a scale
Standard Deviation 3.1
|
2.3 score on a scale
Standard Deviation 3.0
|
|
MDASI-GI Symptom Assessment
Vomiting Severity
|
0.64 score on a scale
Standard Deviation 2.1
|
2.9 score on a scale
Standard Deviation 3.5
|
0.58 score on a scale
Standard Deviation 1.5
|
1.9 score on a scale
Standard Deviation 3.0
|
|
MDASI-GI Symptom Assessment
Bloating Severity
|
1.5 score on a scale
Standard Deviation 2.3
|
3.9 score on a scale
Standard Deviation 3.2
|
1.6 score on a scale
Standard Deviation 2.4
|
2.3 score on a scale
Standard Deviation 2.9
|
|
MDASI-GI Symptom Assessment
Pain Severity
|
2.9 score on a scale
Standard Deviation 3.1
|
5.7 score on a scale
Standard Deviation 3.6
|
4.1 score on a scale
Standard Deviation 3.3
|
3.8 score on a scale
Standard Deviation 3.6
|
|
MDASI-GI Symptom Assessment
Constipation Severity
|
0.55 score on a scale
Standard Deviation 1.3
|
2.7 score on a scale
Standard Deviation 3.9
|
0.77 score on a scale
Standard Deviation 2.2
|
2.2 score on a scale
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Assessed at 5 weeks post registrationPopulation: Eligible and evaluable participants who were alive with data at the assessment time
Ability to consume food was assessed based on self or caregiver-reported 24-hour dietary recalls. Dietary recalls were collected by trained assessors at the University of Arizona Cancer Center Behavioral Measurement and Interventions Shared Resource (BMISR) via telephone using standardized protocols and Nutrient Database for Research.
Outcome measures
| Measure |
Randomization Surgery
n=12 Participants
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=12 Participants
Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=29 Participants
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=40 Participants
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
Ability to Eat
Not eating
|
0 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
|
Ability to Eat
Eating
|
12 Participants
|
12 Participants
|
29 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: From date of registration to maximum of 53 weeksPopulation: Eligible and evaluable participants
Time from date of registration to date of death due to any cause.
Outcome measures
| Measure |
Randomization Surgery
n=24 Participants
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=25 Participants
Patients who are randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=58 Participants
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=92 Participants
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
Overall Survival
|
86 days
Interval 51.0 to 102.0
|
80 days
Interval 39.0 to 102.0
|
156 days
Interval 71.0 to 303.0
|
96 days
Interval 71.0 to 144.0
|
Adverse Events
Randomization Surgery
Serious events: 2 serious events
Other events: 5 other events
Deaths: 19 deaths
Randomization Non-surgical Management
Serious events: 3 serious events
Other events: 1 other events
Deaths: 20 deaths
Patient Choice Surgery
Serious events: 5 serious events
Other events: 12 other events
Deaths: 37 deaths
Patient Choice Non-surgical Management
Serious events: 16 serious events
Other events: 14 other events
Deaths: 68 deaths
Serious adverse events
| Measure |
Randomization Surgery
n=24 participants at risk
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=25 participants at risk
Patients on the randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=58 participants at risk
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=92 participants at risk
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
1/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
2.2%
2/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
General disorders
Death NOS
|
0.00%
0/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
8.0%
2/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
2.2%
2/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Infections and infestations
Sepsis
|
0.00%
0/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
4.3%
4/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
4.2%
1/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
4.0%
1/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
8.6%
5/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
10.9%
10/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Renal and urinary disorders
Renal and urinary disorders-Other
|
0.00%
0/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
1.1%
1/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
1.1%
1/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
2.2%
2/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
Other adverse events
| Measure |
Randomization Surgery
n=24 participants at risk
Patients who are randomized to surgical management undergo therapeutic conventional surgery (abdominal) as defined by the treating physician.
|
Randomization Non-surgical Management
n=25 participants at risk
Patients on the randomized to non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician.
|
Patient Choice Surgery
n=58 participants at risk
Patients who choose surgical management undergo conventional surgery (abdominal) as defined by the treating physician as in Arm 1.
|
Patient Choice Non-surgical Management
n=92 participants at risk
Patients who choose non-surgical management are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm 2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
4/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
4.0%
1/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
13.8%
8/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
14.1%
13/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
12.5%
3/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
5.2%
3/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Infections and infestations
Sepsis
|
8.3%
2/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
1.1%
1/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Infections and infestations
Urinary tract infection
|
8.3%
2/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
3.4%
2/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
2.2%
2/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
5.2%
3/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
8.3%
2/24 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
0.00%
0/25 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
1.7%
1/58 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
|
1.1%
1/92 • From date of registration until death or 53 weeks post registration
CTCAE Version 4.0 was used for routine toxicity reporting and Version 5.0 was used for Serious Adverse Event (SAE) reporting. Patients were assessed for AEs only while hospitalized. 199 patients were evaluable for AEs, including 24 on the Randomization Surgery arm, 25 on the Randomization Non-surgical Management arm, 58 on the Patient Choice Surgery arm, and 92 on the Patient Choice Non-surgical Management arm.
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Additional Information
Palliative and End of Life Care Committee Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60