Trial Outcomes & Findings for Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum (NCT NCT02641691)
NCT ID: NCT02641691
Last Updated: 2021-02-18
Results Overview
* Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
1 year
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Operative Radiation Management of Adenocarcinoma of the Lower Rectum
Baseline characteristics by cohort
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=20 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 1 participant was not evaluable for this outcome measure as they were removed for an adverse event
* Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=19 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Complete Response Rate
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=20 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
n=20 Participants
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel close to my friends
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
18 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with family communication about my illness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
19 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have a lack of energy
|
9 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have nausea
|
19 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Because of my physical condition, I have trouble meeting the needs of my family
|
17 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have pain
|
11 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am bothered by side effects of treatment
|
19 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel ill
|
19 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am forced to spend time in bed
|
17 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I get emotional support from my family
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
20 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I get support from my friends
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
19 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
My family has accepted my illness
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
18 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel close to my partner (or the person who is my main support)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
19 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with my sex life
|
0 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
8 Participants
|
4 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel sad
|
8 Participants
|
8 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with how I am coping with my illness
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am losing hope in the fight against my illness
|
19 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel nervous
|
6 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I worry about dying
|
12 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I worry that my condition will get worse
|
2 Participants
|
9 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am able to work (include work at home)
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
12 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
My work (include work at home) is fulfilling
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am able to enjoy life
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have accepted my illness
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
12 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am sleeping well
|
2 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am enjoying the things I usually do for fun
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
9 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am content with the quality of my life right now
|
0 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have swelling or cramps in my stomach area
|
14 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am losing weight
|
10 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have control of my bowels
|
1 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I can digest my food well
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
13 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have diarrhea (diarrhoea)
|
9 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have a good appetite
|
1 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
13 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I like the appearance of my body
|
0 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am embarrassed by my ostomy appliance
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
20 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Caring for my ostomy appliance is difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Completion of chemoradiation (approximately 112 days)Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation.
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=19 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
n=19 Participants
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have a lack of energy
|
3 Participants
|
3 Participants
|
11 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have nausea
|
16 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Because of my physical condition, I have trouble meeting the needs of my family
|
8 Participants
|
8 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have pain
|
11 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am bothered by side effects of treatment
|
6 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel ill
|
16 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am forced to spend time in bed
|
13 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel close to my friends
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
14 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I get emotional support from my family
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
15 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I get support from my friends
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
16 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
My family has accepted my illness
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
14 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with family communication about my illness
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel close to my partner (or the person who is my main support)
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
17 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with my sex life
|
1 Participants
|
1 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel sad
|
10 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with how I am coping with my illness
|
3 Participants
|
0 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am losing hope in the fight against my illness
|
16 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel nervous
|
5 Participants
|
11 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I worry about dying
|
12 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I worry that my condition will get worse
|
4 Participants
|
11 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am able to work (include work at home)
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
My work (include work at home) is fulfilling
|
0 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am able to enjoy life
|
0 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
7 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have accepted my illness
|
1 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
9 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am sleeping well
|
0 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am enjoying the things I usually do for fun
|
0 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am content with the quality of my life right now
|
0 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have swelling or cramps in my stomach area
|
13 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am losing weight
|
11 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have control of my bowels
|
1 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I can digest my food well
|
0 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
10 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have diarrhea (diarrhoea)
|
4 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have a good appetite
|
1 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I like the appearance of my body
|
2 Participants
|
3 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am embarrassed by my ostomy appliance
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
18 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Caring for my ostomy appliance is difficult
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 10-14 months after chemoradiation (approximately 16-20 months)Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=18 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
n=18 Participants
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have swelling or cramps in my stomach area
|
12 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have a lack of energy
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have nausea
|
17 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Because of my physical condition, I have trouble meeting the needs of my family
|
10 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have pain
|
9 Participants
|
5 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am bothered by side effects of treatment
|
5 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel ill
|
15 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am forced to spend time in bed
|
14 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel close to my friends
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
12 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I get emotional support from my family
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
15 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I get support from my friends
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
13 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
My family has accepted my illness
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
14 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with family communication about my illness
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
15 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel close to my partner (or the person who is my main support)
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
15 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I worry about dying
|
10 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with my sex life
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel sad
|
9 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am satisfied with how I am coping with my illness
|
3 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am losing hope in the fight against my illness
|
15 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I feel nervous
|
6 Participants
|
6 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I worry that my condition will get worse
|
5 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am able to work (include work at home)
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
My work (include work at home) is fulfilling
|
1 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
9 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am able to enjoy life
|
0 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have accepted my illness
|
0 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am sleeping well
|
1 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am enjoying the things I usually do for fun
|
0 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am content with the quality of my life right now
|
0 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am losing weight
|
15 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have control of my bowels
|
2 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I can digest my food well
|
0 Participants
|
1 Participants
|
5 Participants
|
2 Participants
|
10 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have diarrhea (diarrhoea)
|
6 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I have a good appetite
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I like the appearance of my body
|
3 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
I am embarrassed by my ostomy appliance
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
15 Participants
|
|
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
Caring for my ostomy appliance is difficult
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=20 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Number of Any Grade 3 or Higher Toxicities
Syncope
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Respiratory failure
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Aspiration
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Dyspnea
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Hypoxia
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Palmar-plantar erythrodysesthesia syndrome
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Cellulitis
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Hypertension
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Hypotension
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Thromboembolic event
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Anemia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Febrile neutropenia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Cardiac arrest
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Myocardial infarction
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Ventricular fibrillation
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Abdominal pain
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Diarrhea
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Pancreatitis
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Fever
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Cholectystitis
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Lung infection
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Fall
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Activated partial thromboplastin time prolonged
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Aspartate aminotransferase increased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Cardiac troponin I increased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Cardiac troponin T increased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Lymphocyte count decreased
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Neutrophil count decreased
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
White blood cell decreased
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Dehydration
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Hyperglycemia
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Hypokalemia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Hyponatremia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Generalized muscle weakness
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Any Grade 3 or Higher Toxicities
Peripheral sensory neuropathy
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation.
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=19 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Activated partial thromboplastin time prolonged
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Aspartate aminotransferase increased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Cardiac troponin I increased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Cardiac troponin T increased
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Lymphocyte count decreased
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Neutrophil count decreased
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Lung infection
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Anemia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Febrile neutropenia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Cardiac arrest
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Myocardial infarction
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Ventricular fibrillation
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Abdominal pain
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Diarrhea
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Fever
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Cholecystitis
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
White blood cell count decreased
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Dehydration
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Hyperglycemia
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Hypokalemia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Hyponatremia
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Generalized muscle weakness
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Peripheral sensory neuropathy
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Syncope
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Respiratory failure
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Aspiration
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Dyspnea
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Hypoxia
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Cellulitis
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Hypotension
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Post Chemotherapy Grade 3 or Higher Toxicities
Thromboembolic event
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=20 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
n=20 Participants
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
I have control of my bowels
|
1 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
11 Participants
|
—
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
I have diarrhea (diarrhoea)
|
9 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Completion of chemoradiation (approximately 112 days)Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation.
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=19 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
n=19 Participants
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
I have control of my bowels
|
1 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
—
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
I have diarrhea (diarrhoea)
|
4 Participants
|
10 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 10-14 months after chemoradiation (approximately 16-20 months)Population: One participant was not evaluable for this outcome measure because they did not complete chemoradiation. One participant was not evaluable for this outcome measure because they expired prior to this timepoint.
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Outcome measures
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=18 Participants
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
1=A Little Bit
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
2=Somewhat
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
3=Quite a Bit
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
4=Very Much
n=18 Participants
-Participant is asked about specific well-being in the past 7 days
|
Prefer Not to Answer/No Answer/No
-Participant did not answer question about well-being
|
|---|---|---|---|---|---|---|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
I have control of my bowels
|
2 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
2 Participants
|
—
|
|
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
I have diarrhea (diarrhoea)
|
6 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
Adverse Events
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
Serious events: 8 serious events
Other events: 20 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=20 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Cardiac disorders
Myocardial infarction
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Cardiac disorders
Cardiac arrest
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Infections and infestations
Lung infection
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Vascular disorders
Thromboembolic event
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Gastrointestinal disorders
Pancreatitis
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
Other adverse events
| Measure |
Arm 1: Radiation/Oxaliplatin/Leucovorin/5-FU
n=20 participants at risk
* Radiotherapy will consist of five fractions, delivered once daily, to a total dose of 25Gy at 5 Gy per fraction.
* An optional concomitant boost may be delivered to the primary tumor of 1-2 Gy per day (30-35 Gy to tumor total). If a boost is given then the maximum allowed dose to small bowel is 25 Gy.
* Chemotherapy should begin two weeks (9-12 working days) after completion of radiotherapy.
* Oxaliplatin will be given intravenous (IV) over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* Leucovorin will be given IV over 2 hours on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU bolus will given IV push on Day 1 every 14 days for a maximum of 8 cycles.
* 5-FU infusion will be given continuous IV on Day 1 over 46 hours every 14 days for a maximum of 8 cycles
* Alternatively, capecitabine/oxaliplatin (CAPE PO 1000 mg/m2 BID days 1-14 Q21 days, oxaliplatin IV 130 mg/m2 IV Q21 days on day 1) x 5 cycles over 15 weeks may be administered instead of FOLFOX
|
|---|---|
|
General disorders
Fatigue
|
20.0%
4/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
General disorders
Fever
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Hepatobiliary disorders
Cholecystitis
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
Aspartate aminotransferase
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
Cardiac troponin I increased
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Blood and lymphatic system disorders
Anemia
|
15.0%
3/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Cardiac disorders
Ventricular fibrillation
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
5/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Gastrointestinal disorders
Rectal pain
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
Cardiac troponin T increased
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
Lymphocyte count decreased
|
15.0%
3/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
Neutrophil count decreased
|
25.0%
5/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Investigations
White blood cell decreased
|
15.0%
3/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
2/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
15.0%
3/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
General disorders
Generalized muscle weakness
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.0%
6/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Nervous system disorders
Cold sensitivity
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Psychiatric disorders
Anxiety
|
10.0%
2/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Renal and urinary disorders
Hematuria
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Skin and subcutaneous tissue disorders
Bottom of feet felt sun burnt
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Adverse events were collected from start of treatment until 1 year post start of radiation therapy (approximately 1 year and 4 months).
|
Additional Information
Hyun Kim, M.D.
Washington University School of Medicine
Phone: 314-362-8502
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place