TerminatedNCT01445327Updated Feb 1, 2022Results posted

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

An observational study in Esophageal Cancer, Stomach Cancer and Pancreatic Cancer, sponsored by National Cancer Institute (NCI). Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by National Cancer Institute (NCI) · Observational

Why this study was terminated

Slow, insufficient accrual.

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 9
Ages: 18 Years and older
Sex: All

Study summary

Background:

Gastrointestinal cancers are among the most commonly diagnosed cancers in the United States.
There are currently no tests to predict how patients with gastrointestinal cancers will respond to radiation therapy or which patients may develop side effects from treatment.
Studies on tumor cells in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients may need more or less aggressive therapy.
Studies of other substances in the stool, urine, or blood from patients may provide valuable information that can be used to develop tests to determine which patients are likely to develop side effects from radiation treatments.

Objectives:

To collect blood, urine and stool specimens from patients with gastrointestinal cancers who will undergo radiation therapy.
To study hormone and protein changes in these blood, urine and stool specimens before, during and after radiation treatment in order to develop a way to predict how gastrointestinal cancers will respond to radiation therapy and if patients with these cancers will develop side effects from radiation treatment.

Eligibility:

-Patients 18 years of age and older with cancer of the gastrointestinal tract (esophagus, stomach, pancreas, rectum) who plan to receive radiotherapy to the site of the cancer on an National Cancer Institute (NCI) protocol

Design:

Participants undergo the following procedures:

Tumor biopsy: Before any treatment or at the time of surgery if it is the first treatment
Urine collection: Before, during, and after treatment and at follow-up visits.
Stool collection: Before, during, and after treatment and at follow-up visits.
Blood collection: Before, during, and after treatment and at follow-up visits.
Intestinal permeability assessment: Before any treatment, before radiation (if radiation is not the first treatment), 1 month after radiation is completed, and 3 months after radiation is completed. This test determines how the patients intestines are working to absorb sugar and may provide information about side effects from radiation treatments. Patients fast after midnight, then drink a small glass of sugars, and then do a 6-hour urine collection.

Read the detailed description

Background:

Gastrointestinal (GI) carcinomas represent one of the most commonly diagnosed malignancies in the United States.
A sensitive and specific marker of tumor persistence or recurrence would permit a more accurate determination of the appropriateness of adjuvant therapy in patients with no clinical evidence of disease following curative resection and allow the diagnosis of recurrences at earlier stages that may be amenable to curative salvage therapies.
A biomarker detectable shortly after treatment or in the early stages of chronic radiation toxicity may allow the identification of patients at risk and early intervention.

Objectives:

Our primary objective is to determine if patient specific tumor markers in stool, urine, or serum can be reliably detected prior to treatment and followed after treatment to monitor the extent of residual disease.
A second objective is to evaluate the predictive value of potential markers of chronic gastrointestinal injury after radiotherapy.

Eligibility:

Age greater than or equal to 18 years
Histologically confirmed carcinoma of the gastrointestinal tract (esophagus, stomach, pancreas, rectum)
Planned to receive radiotherapy to the site of the gastrointestinal malignancy on an National Cancer Institute (NCI) protocol

Design:

This protocol provides a means of acquiring tissue, serum, urine, and stool samples from patients who will receive radiation therapy as part of their treatment for gastrointestinal malignancies.
Patients treated with radiation therapy on NCI treatment protocols will be asked to provide samples prior to any local or systemic therapy as well as before, during and after their radiation treatment.
These samples will be tested for the presence of tumor specific deoxyribonucleic acid (DNA) mutations and aberrant methylation patterns determined to be present in each patient's tumor by screening of initial biopsy or surgical material.
Tumor markers specific to each patient, such as tumor specific DNA mutations or aberrant DNA methylation, may provide an individualized method to evaluate disease status and determine prognosis after therapy. Additionally, a number of stool and serum markers will be explored as early indicators of acute and eventual chronic gastrointestinal injury in patients receiving radiotherapy to the abdomen.

Conditions studied

Esophageal Cancer
Stomach Cancer
Pancreatic Cancer

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Keywords

Blood
Urine
Stool
Tumor Marker
Radiation Therapy
Gastrointestinal Cancer
Esophageal Cancer
Stomach
Pancreatic Cancer

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 9 is below the median of 200 across 620 observational studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

Patients with gastrointestinal tumors that will receive radiation therapy at the National Institutes of Health (NIH) Clinical Center as part of their treatment.

Inclusion criteria

Age greater than or equal to 18 years.
Histologically confirmed carcinoma of the gastrointestinal tract (esophagus, stomach, pancreas, bile duct, rectum).
Treatment plan includes radiotherapy to the site of the gastrointestinal malignancy on an National Cancer Institute (NCI) protocol.
Paraffin embedded tumor tissue from biopsy or surgery adequate in amount to perform polymerase chain reaction (PCR) and methylation specific PCR or willingness to undergo re-biopsy.

Exclusion criteria

EXCLUSION CRITERIA:

Inability to provide informed consent.
Patients who have a history of prior therapeutic radiation.
Patients with evidence of distant metastases on initial staging evaluation.
Patients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ.
History of inflammatory bowel disease.
History of collagen vascular disease or disease of altered collagen metabolism (end stage renal disease or hepatic fibrosis due to chronic hepatitis).
History of hypersensitivity to radiation or a history of a disease which results in mucosal or other hypersensitivity to radiation (Ataxia-Telangiectasia, Bloom's Syndrome, Human Immunodeficiency Virus, Fanconi anemia, nevoid basal cell carcinoma syndrome, Li-Fraumeni syndrome, and Nijmegen breakage syndrome).
Inability to return for follow-up visits.
Patients who have previously received or are currently receiving MDX-101 (ipilimumab).
Diagnosis of human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C.

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 9 participants (actual)
Biospecimen retention: Samples with dna

Groups and cohorts

Markers of Tumor Burden and Radiation Toxicity
Serum, plasma, urine, and stool samples will be collected prior to radiotherapy for participants with gastrointestinal malignancies.
Other: Specimen collection

Interventions

OtherSpecimen collection

What researchers measure

Primary outcomes

Number of Participants With Specific Tumor Markers in Stool, Urine, or Serum Detected Prior to Treatment and After Treatment
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.
Time frame: Prior to treatment (baseline) and after treatment, up to 19 months

Secondary outcomes

Number of Participants With Chronic Gastrointestinal Injury After Radiotherapy
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.
Time frame: After radiotherapy, up to 19 months

Other outcomes

Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0.
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.
Time frame: Date treatment consent signed to date off study, an average of 19 months

Results

Posted Feb 1, 2022

Participant flow

Participant flow — Overall Study
Milestone	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda
Started	3	1	5
Completed	3	1	5
Not completed	0	0	0

Outcome measures

PrimaryNumber of Participants With Specific Tumor Markers in Stool, Urine, or Serum Detected Prior to Treatment and After Treatment

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.

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

No measurements were reported for this outcome.

SecondaryNumber of Participants With Chronic Gastrointestinal Injury After Radiotherapy

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.

Time frame:: After radiotherapy, up to 19 months

No measurements were reported for this outcome.

Other pre-specifiedHere is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0.

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.

Time frame:: Date treatment consent signed to date off study, an average of 19 months
Reported as:: Count of participants · Participants

Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0.
Participants	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda
Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0.	0	0	0

Adverse events

Collected over Date treatment consent signed to date off study, an average of 19 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	0/3 (0%)	0/3 (0%)	0/3 (0%)
Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	0/1 (0%)	0/1 (0%)	0/1 (0%)
Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	0/5 (0%)	0/5 (0%)	0/5 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	Total
<=18 years	0	0	0	0
Between 18 and 65 years	2	0	5	7
>=65 years	1	1	0	2

Age, Continuous
Age, Continuous(years)	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	Total
Mean	61.55 ± 14.19	69 ± 0	54.75 ± 2.96	61.76 ± 8.57

Sex: Female, Male
Sex: Female, Male(Participants)	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	Total
Female	1	0	3	4
Male	2	1	2	5

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	Total
Hispanic or Latino	0	0	0	0
Not Hispanic or Latino	3	1	5	9
Unknown or Not Reported	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	Total
American Indian or Alaska Native	0	0	0	0
Asian	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	0	0	1	1
White	3	1	4	8
More than one race	0	0	0	0
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	Total
United States	3	1	5	9

Study locations

1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland 20892, United States

References and documents

Publications

Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA Cancer J Clin. 2006 Mar-Apr;56(2):106-30. doi: 10.3322/canjclin.56.2.106. PubMed 16514137 ↗
Seamonds B, Yang N, Anderson K, Whitaker B, Shaw LM, Bollinger JR. Evaluation of prostate-specific antigen and prostatic acid phosphatase as prostate cancer markers. Urology. 1986 Dec;28(6):472-9. doi: 10.1016/0090-4295(86)90146-9. PubMed 2431533 ↗
Guillet J, Role C, Duc AT, Francois H. Prostate-specific antigen (PSA) in the management of 500 prostatic patients. Am J Clin Oncol. 1988;11 Suppl 2:S61-2. doi: 10.1097/00000421-198801102-00013. PubMed 2468274 ↗

Study documents

Protocol, analysis plan and consent form · Feb 11, 2007

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01445327
Lead sponsor: National Cancer Institute (NCI)
Responsible party: Deborah Citrin, M.D. (Principal Investigator, National Cancer Institute (NCI)) — Principal investigator
First posted: Oct 3, 2011
Start date: Feb 20, 2007
Primary completion: May 22, 2014
Completion: May 22, 2014
Results posted: Feb 1, 2022
Last update: Feb 1, 2022

Study contacts

Deborah E Citrin, M.D.

principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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