NCT01515787 · BASELINE

Baseline characteristics

PROSPECT: Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery · Source last updated 2024-02-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants

groups

description
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. \> \> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. \> \> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. \> \> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
id
BG000
title
Group 1
description
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. \> \> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.\> \> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.\> \> surgery: low anterior resection with total mesorectal excision
id
BG001
title
Group 2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
19
upper Limit
91
value
57
group Id
BG001
lower Limit
25
upper Limit
84
value
57
group Id
BG002
lower Limit
19
upper Limit
91
value
57
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
216
group Id
BG001
value
173
group Id
BG002
value
389
title
Female
measurements
group Id
BG000
value
369
group Id
BG001
value
370
group Id
BG002
value
739
title
Male
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
48
group Id
BG002
value
96
title
Hispanic or Latino
measurements
group Id
BG000
value
516
group Id
BG001
value
475
group Id
BG002
value
991
title
Not Hispanic or Latino
measurements
group Id
BG000
value
21
group Id
BG001
value
20
group Id
BG002
value
41
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
31
group Id
BG001
value
19
group Id
BG002
value
50
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
32
group Id
BG001
value
17
group Id
BG002
value
49
title
Black or African American
measurements
group Id
BG000
value
492
group Id
BG001
value
467
group Id
BG002
value
959
title
White
measurements
group Id
BG000
value
30
group Id
BG001
value
40
group Id
BG002
value
70
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
45
group Id
BG002
value
96
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
19
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Switzerland
categories
measurements
group Id
BG000
value
524
group Id
BG001
value
489
group Id
BG002
value
1013
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Country of residence
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
14.5
upper Limit
65.4
value
28.4
group Id
BG001
lower Limit
15.8
upper Limit
81.4
value
28.1
group Id
BG002
lower Limit
14.5
upper Limit
81.4
value
28.3
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Body-mass index
unit Of Measure
kg/m^2
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
83
group Id
BG002
value
164
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
504
group Id
BG001
value
460
group Id
BG002
value
964
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
No
param Type
COUNT_OF_PARTICIPANTS
title
History of diabetes
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
106
group Id
BG001
value
98
group Id
BG002
value
204
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
479
group Id
BG001
value
445
group Id
BG002
value
924
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
No
param Type
COUNT_OF_PARTICIPANTS
title
History of cardiovascular disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
29
group Id
BG002
value
58
denoms
counts
group Id
BG000
value
568
group Id
BG001
value
531
group Id
BG002
value
1099
units
Participants
title
Less than high school
categories
measurements
group Id
BG000
value
214
group Id
BG001
value
201
group Id
BG002
value
415
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
High school diploma or GED certificate
categories
measurements
group Id
BG000
value
119
group Id
BG001
value
102
group Id
BG002
value
221
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Some college
categories
measurements
group Id
BG000
value
206
group Id
BG001
value
199
group Id
BG002
value
405
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
College degree or higher
param Type
COUNT_OF_PARTICIPANTS
population Description
Missing Patient Data
title
Highest education level
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
582
group Id
BG001
value
540
group Id
BG002
value
1122
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
0 or 1
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
2
description
ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction. \> ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. \> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. \> ECOG = 0 is better. ECOG = 2 is worse.
param Type
COUNT_OF_PARTICIPANTS
title
ECOG performance-status score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
290
group Id
BG001
value
259
group Id
BG002
value
549
denoms
counts
group Id
BG000
value
580
group Id
BG001
value
536
group Id
BG002
value
1116
units
Participants
title
Rectal tumor not palpable
categories
measurements
group Id
BG000
value
290
group Id
BG001
value
277
group Id
BG002
value
567
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Rectal tumor palpable
param Type
COUNT_OF_PARTICIPANTS
population Description
Missing Patient Data
title
Primary rectal tumor on digital examination
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
2
upper Limit
25
value
8
group Id
BG001
lower Limit
2
upper Limit
18
value
8
group Id
BG002
lower Limit
2
upper Limit
25
value
8
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Rectal tumor location
unit Of Measure
cm

Complete source fields

denoms

counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants

groups

description
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery. \> \> If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. \> \> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. \> \> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week.
id
BG000
title
Group 1
description
Patients receive 5FUCMT including chemotherapy and radiation therapy for 5.5 weeks. Patients will be given either 5-fluorouracil or capecitabine and radiation therapy. After the chemoradiation therapy is completed, patients will proceed directly to surgery. Post-surgery, patients will receive FOLFOX chemotherapy once every two weeks for 8 cycles total over a period of 16 weeks. \> \> FOLFOX (chemotherapy): Oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1, leucovorin 400 mg/m\^2 bolus IV over 2 hours on day 1 and 5-fluorouracil 400 mg/m\^2 bolus over 5-15 minutes then 2400 mg/m\^2 continual over 46-48 hours total dose IV on days 1-2. The treatment schedule repeats based on the group. Dose modifications are allowed based on adverse events.\> \> 5 FUCMT (chemoradiation): 5-fluorouracil 225 mg/m\^2 per day continuous IV infusion administered concurrently with radiation therapy for 5 or 7 days per week OR capecitabine 825 mg/m\^2 twice daily administered orally and concurrently with radiation therapy for 5 days per week. Dose modifications are allowed based on adverse events.\> \> surgery: low anterior resection with total mesorectal excision
id
BG001
title
Group 2
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
lower Limit
19
upper Limit
91
value
57
group Id
BG001
lower Limit
25
upper Limit
84
value
57
group Id
BG002
lower Limit
19
upper Limit
91
value
57
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
216
group Id
BG001
value
173
group Id
BG002
value
389
title
Female
measurements
group Id
BG000
value
369
group Id
BG001
value
370
group Id
BG002
value
739
title
Male
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
48
group Id
BG001
value
48
group Id
BG002
value
96
title
Hispanic or Latino
measurements
group Id
BG000
value
516
group Id
BG001
value
475
group Id
BG002
value
991
title
Not Hispanic or Latino
measurements
group Id
BG000
value
21
group Id
BG001
value
20
group Id
BG002
value
41
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
31
group Id
BG001
value
19
group Id
BG002
value
50
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
32
group Id
BG001
value
17
group Id
BG002
value
49
title
Black or African American
measurements
group Id
BG000
value
492
group Id
BG001
value
467
group Id
BG002
value
959
title
White
measurements
group Id
BG000
value
30
group Id
BG001
value
40
group Id
BG002
value
70
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
51
group Id
BG001
value
45
group Id
BG002
value
96
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Canada
categories
measurements
group Id
BG000
value
10
group Id
BG001
value
9
group Id
BG002
value
19
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Switzerland
categories
measurements
group Id
BG000
value
524
group Id
BG001
value
489
group Id
BG002
value
1013
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
United States
param Type
COUNT_OF_PARTICIPANTS
title
Country of residence
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
14.5
upper Limit
65.4
value
28.4
group Id
BG001
lower Limit
15.8
upper Limit
81.4
value
28.1
group Id
BG002
lower Limit
14.5
upper Limit
81.4
value
28.3
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Body-mass index
unit Of Measure
kg/m^2
classes
categories
measurements
group Id
BG000
value
81
group Id
BG001
value
83
group Id
BG002
value
164
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
504
group Id
BG001
value
460
group Id
BG002
value
964
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
No
param Type
COUNT_OF_PARTICIPANTS
title
History of diabetes
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
106
group Id
BG001
value
98
group Id
BG002
value
204
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Yes
categories
measurements
group Id
BG000
value
479
group Id
BG001
value
445
group Id
BG002
value
924
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
No
param Type
COUNT_OF_PARTICIPANTS
title
History of cardiovascular disease
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
29
group Id
BG001
value
29
group Id
BG002
value
58
denoms
counts
group Id
BG000
value
568
group Id
BG001
value
531
group Id
BG002
value
1099
units
Participants
title
Less than high school
categories
measurements
group Id
BG000
value
214
group Id
BG001
value
201
group Id
BG002
value
415
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
High school diploma or GED certificate
categories
measurements
group Id
BG000
value
119
group Id
BG001
value
102
group Id
BG002
value
221
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Some college
categories
measurements
group Id
BG000
value
206
group Id
BG001
value
199
group Id
BG002
value
405
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
College degree or higher
param Type
COUNT_OF_PARTICIPANTS
population Description
Missing Patient Data
title
Highest education level
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
582
group Id
BG001
value
540
group Id
BG002
value
1122
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
0 or 1
categories
measurements
group Id
BG000
value
3
group Id
BG001
value
3
group Id
BG002
value
6
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
2
description
ECOG = 0: Fully active, able to carry on all pre-disease performance without restriction. \> ECOG = 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. \> ECOG = 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours. \> ECOG = 0 is better. ECOG = 2 is worse.
param Type
COUNT_OF_PARTICIPANTS
title
ECOG performance-status score
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
290
group Id
BG001
value
259
group Id
BG002
value
549
denoms
counts
group Id
BG000
value
580
group Id
BG001
value
536
group Id
BG002
value
1116
units
Participants
title
Rectal tumor not palpable
categories
measurements
group Id
BG000
value
290
group Id
BG001
value
277
group Id
BG002
value
567
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
title
Rectal tumor palpable
param Type
COUNT_OF_PARTICIPANTS
population Description
Missing Patient Data
title
Primary rectal tumor on digital examination
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
lower Limit
2
upper Limit
25
value
8
group Id
BG001
lower Limit
2
upper Limit
18
value
8
group Id
BG002
lower Limit
2
upper Limit
25
value
8
denoms
counts
group Id
BG000
value
585
group Id
BG001
value
543
group Id
BG002
value
1128
units
Participants
dispersion Type
FULL_RANGE
param Type
MEDIAN
title
Rectal tumor location
unit Of Measure
cm

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice