NCT01445327

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

Terminated Results posted Last updated 1 February 2022

What this trial tests

trial testing Specimen collection in Esophageal Cancer in 9 participants. Terminated before completion.

Timeline

20 February 2007

Primary endpoint
22 May 2014

22 May 2014

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	9
Start date	20 February 2007
Primary completion	22 May 2014
Estimated completion	22 May 2014
Sites	1 location across United States

Drugs / interventions tested

• Specimen collection

Conditions studied

• Esophageal Cancer — all drugs for Esophageal Cancer →
• Stomach Cancer — all drugs for Stomach Cancer →
• Pancreatic Cancer — all drugs for Pancreatic Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Esophageal Cancer or Stomach Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Here is the Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Toxicity Criteria (CTC) v3.0. Secondary · 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 outcome

Group	Value	95% CI
Participants With Esophageal Cancer Treated With 4680-5040 Centigray (cGy) Total Dose + Chemotherapy	0
Participants With Pancreatic Cancer Treated With 5400 Centigray (cGy) + Xeloda	0
Participants With Rectal Cancer Treated With 5040 Centigray (cGy) With Concurrent Xeloda	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.