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Anti-metabolites

Radiation Therapy + Capecitabine for Rectal Cancer

Phase 2

Waitlist Available

Led By Gwyn Bebb, MD

Research Sponsored by Alberta Health Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status >70

Transmural rectal wall invasion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether preoperative radiation therapy and capecitabine can effectively treat locally advanced rectal cancer.

Who is the study for?

This trial is for individuals with locally advanced rectal cancer that has spread through the rectal wall. Participants must be in good physical condition (Karnofsky score >70) and have normal bone marrow, liver, and kidney function. It's not suitable for those who've had pelvic radiation before, have cancer spread to distant parts of the body, are pregnant, suffer from inflammatory bowel disease or severe heart issues, or are on blood thinners.Check my eligibility

What is being tested?

The study is testing how well a combination of preoperative radiation therapy and capecitabine works in treating patients with locally advanced rectal cancer. The goal is to see if this treatment can effectively reduce the size or extent of the cancer before surgery.See study design

What are the potential side effects?

Potential side effects may include skin irritation from radiation, fatigue, nausea, diarrhea due to capecitabine as well as possible changes in blood counts leading to increased risk of infections or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform normal activities with minimal assistance.

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My cancer has spread through the wall of my rectum.

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My bone marrow, liver, and kidney are functioning normally.

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My rectal cancer diagnosis was confirmed through a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

response

safety

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alberta Health ServicesLead Sponsor

36 Previous Clinical Trials

1,736 Total Patients Enrolled

Alberta Health servicesLead Sponsor

157 Previous Clinical Trials

649,516 Total Patients Enrolled

Gwyn Bebb, MDPrincipal InvestigatorAlberta Health services

1 Previous Clinical Trials

52 Total Patients Enrolled

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00122291 — Phase 2

Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT00122291 — Phase 2

Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00122291 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study recruiting new participants?

"Clinicaltrials.gov indicates that this test is no longer recruiting participants, as the most recent update dates back to January 18th 2012. Although not actively searching for patients anymore, there are nearly 1,000 other medical studies now looking for volunteers."

Answered by AI

Has this therapeutic intervention obtained clearance from the Food and Drug Administration?

"The safety of this therapeutic intervention was rated as a 2, taking into account the Phase 2 trial and its concomitant lack of efficacy-related data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer

2002. "A Study of Preoperative Radiation Therapy and Capecitabine in Locally Advanced Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00122291.

All > Bone Metastases > Rectal Cancer