Trial Outcomes & Findings for Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer (NCT NCT01148056)
NCT ID: NCT01148056
Last Updated: 2017-02-15
Results Overview
To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.
TERMINATED
PHASE2
2 participants
2 years
2017-02-15
Participant Flow
Participant milestones
| Measure |
Short Course IMRT
Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intensity Modulated Radiation Therapy (IMRT) for Patients With Rectal Cancer
Baseline characteristics by cohort
| Measure |
Short Course IMRT
n=2 Participants
Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=113 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=113 Participants
|
|
Gender
Female
|
0 Participants
n=113 Participants
|
|
Gender
Male
|
2 Participants
n=113 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=113 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=113 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Study was terminated early due to slow accrual. Analysis was not performed.
To determine the rate of fecal incontinence at 1 year in patients undergoing an low anterior resection (LAR), as measured by bowel quality of life measure after preoperative conformal radiation therapy delivered in one week for rectal cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was closed early due to poor accrual. Analyses not completed.
To determine the pelvic control rate of patients after short course radiation therapy and surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was closed early due to poor accrual. Analyses not completed.
To determine the surgical complication rate in patients who received preoperative radiation therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was closed early due to poor accrual. Analyses not completed.
To determine changes in the tumor induced by radiation as assessed by tissue microarray.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was closed early due to poor accrual. Analyses not completed.
To determine the impact of radiation and surgery on quantity of circulating tumor cells in both metastatic and non-metastatic patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Study was closed early due to poor accrual. Analyses not completed.
To determine the accuracy of advanced MRI imaging and PET (Positron Electron Tomography) /CT in predicting nodal stage.
Outcome measures
Outcome data not reported
Adverse Events
Short Course IMRT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Short Course IMRT
n=2 participants at risk
Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after
Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days
|
|---|---|
|
Infections and infestations
urinary tract infection
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Gastrointestinal disorders
vomiting
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Gastrointestinal disorders
nausea
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Nervous system disorders
confusion
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Renal and urinary disorders
urinary retention
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Blood and lymphatic system disorders
platelets
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Metabolism and nutrition disorders
elevated bilirubin
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Metabolism and nutrition disorders
low phosphorus
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Blood and lymphatic system disorders
anemia
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
General disorders
fever
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Blood and lymphatic system disorders
lymphopenia
|
100.0%
2/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Blood and lymphatic system disorders
leukopenia
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
100.0%
2/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Gastrointestinal disorders
diarrhea
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Blood and lymphatic system disorders
edema
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
erythema
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
pilonidal abscess
|
50.0%
1/2 • 30 Days
Adverse events experienced by participants will be collected and reported from initiation of study treatment, throughout the study, and within 30 days of the last dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place