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Radiation

Ultra-fractionated Radiotherapy for Rectal Cancer

Phase 1

Recruiting

Led By Nina Sanford, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

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

Must have

T3-4 and/or N+ disease per AJCC 8th edition

Pathologic diagnosis of rectal adenocarcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new way to treat rectal cancer that may be more effective than current methods.

Who is the study for?

Adults with locally advanced rectal cancer who haven't had previous treatment for it. They must have good organ and bone marrow function, no distant nodal or metastatic disease, and a stable health condition without severe psychiatric illness. Participants need to agree to use contraception during the trial.Check my eligibility

What is being tested?

The trial is testing a new approach called ultra-fractionated radiotherapy combined with chemotherapy in patients with rectal cancer. The goal is to see if this method allows for better control of the disease without surgery.See study design

What are the potential side effects?

Potential side effects may include skin irritation, fatigue, nausea, diarrhea from radiation; plus additional risks from chemotherapy like lowered blood counts leading to infection risk, bruising or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is at a stage where it has grown into surrounding tissues or spread to nearby lymph nodes.

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I have been diagnosed with rectal cancer.

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My kidney function is within normal limits.

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My recent blood tests show my organs are functioning well.

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I am able to get out of my bed or chair and move around.

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I have not received any treatment for rectal cancer.

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I have not had my uterus or both ovaries removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To determine the maximal tolerated dose (MTD) of dose-escalated hypofractionated RT.

Secondary outcome measures

For patients undergoing surgery, to evaluate the rate of R0 resection, defined as a negative surgical margin at time of total mesorectal excision.

Pharmacotherapy

Disease

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Phase I Dose CohortsExperimental Treatment1 Intervention

DOSE LEVEL 1 : 30 Gy (tumor)/ 25 Gy (pelvis) DOSE LEVEL 2 : 35 Gy (tumor)/ 25 Gy (pelvis) DOSE LEVEL 3 : 40 Gy (tumor)/ 25 Gy (pelvis)

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,047 Previous Clinical Trials

1,053,772 Total Patients Enrolled

Nina Sanford, MD1.01 ReviewsPrincipal Investigator - UT SOUTHWESTERN medical CENTRE

University of Texas Southwestern Medical Center

Media Library

$Ultrafractionated Radiotherapy for Rectal Cancer (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT04677413 — Phase 1$

Colorectal Cancer Research Study Groups: Phase I Dose Cohorts

$Colorectal Cancer Clinical Trial 2023: Ultrafractionated Radiotherapy for Rectal Cancer Highlights & Side Effects. Trial Name: NCT04677413 — Phase 1$

$Ultrafractionated Radiotherapy for Rectal Cancer (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677413 — Phase 1$

Frequently Asked Questions

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

Are there any opportunities for participants to enroll in this research study?

"According to the information posted on clinicaltrials.gov, this particular trial is accepting participants at present time. It was first published on June 3rd 2021 and underwent its last update November 30th 2022."

Answered by AI

Has Ultrafractionated radiotherapy for rectal cancer earned regulatory clearance?

"As this is a Phase 1 trial, and data regarding its safety and efficacy are rather limited, our team at Power assigned Ultrafractionated radiotherapy for rectal cancer a score of 1."

Answered by AI

What are the ultimate objectives of this experiment?

"This clinical trial, to be assessed from 0-60 days after radiation therapy, has been designed with the aim of measuring toxicity - as shown by number of participants experiencing side effects according to CTCAE v5.0 guidelines. Additional secondary objectives include determining disease-free survival (DFS) rate within a year post treatment; tracking local regional recurrence timeline since completion of intervention; and quantifying rates of complete or near complete response based on endoscopic and MRI assessments at 4-8 weeks following chemotherapy and radiotherapy."

Answered by AI

How many participants are contributing to this clinical trial?

"Affirmative. According to the clinicaltrials.gov database, this experiment is actively searching for participants and was first posted on June 3rd 2021. The most up-to-date report was released November 30th 2022, with a goal of recruiting 27 patients from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ultra-fractionated Radiotherapy for Rectal Cancer

Nina Sanford 2021. "Ultra-fractionated Radiotherapy for Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677413.

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