Trial Outcomes & Findings for Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers (NCT NCT01445327)

Last Updated: 2022-02-01

Results Overview

Here are the number of participants with specific tumor markers in stool, urine, or serum detected prior to treatment and after treatment to monitor the extent of residual disease.

Recruitment status

TERMINATED

Target enrollment

9 participants

Primary outcome timeframe

Prior to treatment (baseline) and after treatment, up to 19 months

Results posted on

2022-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant.	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant.	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant.
Overall Study STARTED	3	1	5
Overall Study COMPLETED	3	1	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of Tumor Response and of Radiation Therapy Side Effects in Patients With Gastrointestinal Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy n=3 Participants Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant.	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda n=1 Participants Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant.	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda n=5 Participants Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant.	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	61.55 years STANDARD_DEVIATION 14.19 • n=5 Participants	69 years STANDARD_DEVIATION 0 • n=7 Participants	54.75 years STANDARD_DEVIATION 2.96 • n=5 Participants	61.76 years STANDARD_DEVIATION 8.57 • n=4 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	3 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants	9 participants n=4 Participants

PRIMARY outcome

Timeframe: Prior to treatment (baseline) and after treatment, up to 19 months

Population: A minimum of 120 participants must be enrolled to perform analyses to determine specific tumor markers in stool, urine for this outcome measure. Because the study was prematurely terminated due to slow, insufficient accrual and requirements for enrolment, assays were not performed on the collected samples, thus no data is reported for this outcome measure. It would be inappropriate to report an analysis for this outcome measure based on the enrollment of 9 participants.

Here are the number of participants with specific tumor markers in stool, urine, or serum detected prior to treatment and after treatment to monitor the extent of residual disease.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: After radiotherapy, up to 19 months

Population: A minimum of 120 participants must be enrolled to perform analyses to determine gastrointestinal injury for this outcome measure. Because the study was prematurely terminated due to slow, insufficient accrual, and requirements for enrolment, analyses were not performed, and no data is reported for this outcome measure. It would be inappropriate to report an analysis for this outcome measure based on the enrollment of 9 participants.

Gastrointestinal injury after radiotherapy is influenced by radiation dose (i.e. radiation toxicity) delivered to abdominal organs and can result in gastrointestinal radiation toxicity. Early detection of radiation toxicity (i.e. inflammation, fibrosis) may lead to a good outcome for a participant and late detection and radiation toxicity in the intestinal wall may lead to a bad outcome for a participant.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, an average of 19 months

Here is the number of participants with serious and non-serious adverse events assessed by the Common Toxicity Criteria (CTC) v3.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy n=3 Participants Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with esophageal cancer received 4680-5040 cGy total dose, generally with concurrent chemotherapy (cisplatin and Fluorouracil (5-FU). Treatment cycles varied by participant.	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda n=1 Participants Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with pancreatic cancer received 5400 cGy with Xeloda. Treatment cycles varied by participant.	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda n=5 Participants Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies. Participants with rectal cancer received 5040 cGy with concurrent Xeloda. Treatment cycles varied by participant.
Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0.	0 Participants	0 Participants	0 Participants

Adverse Events

Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Deborah E. Citrin

National Cancer Institute

Phone: 301-496-5457

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place