Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer

NCT ID: NCT04139967

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2022-08-03

Brief Summary

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This study will help determine if a short course of radiation therapy is effective to treat rectal cancer in older patients. A shorter course of radiation treatment may be better tolerated than a longer course or surgery for the treatment of rectal cancer in the elderly.

Detailed Description

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Conditions

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Cancer, Rectal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Elderly rectal cancer patients

Group Type EXPERIMENTAL

Short course radiation therapy

Intervention Type RADIATION

25 Gray in 5 fractions over 5-7 days

Interventions

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Short course radiation therapy

25 Gray in 5 fractions over 5-7 days

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 70 years or older at time of diagnosis
* No restrictions on gender or ethnicity
* Ability and willingness to make follow up appointments
* Pathologic diagnosis of rectal cancer
* Presentation could be symptomatic or asymptomatic
* T1-T3 primary rectal adenocarcinoma as determined on TRUS, CT, or MRI pelvis
* Peri-rectal node positive allowed
* Inability to tolerate radical surgery, as judged by geriatric oncology or surgeon and tumor board OR patient refusal of surgery
* Inability to receive chemoradiation therapy, defined as concurrent chemotherapy and radiation doses of 45-50.4 Gy, as judged by radiation, medical, or geriatric oncology
* Patients with dementia eligible if Health Care Proxy (HCP) is available and supportive of follow up schedule

Exclusion Criteria

* Age under 70 years of age
* Ability and desire to receive definitive surgical intervention
* Ability and desire to receive concurrent chemoradiation therapy
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Haoming (Carl) Qiu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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4297

Identifier Type: -

Identifier Source: org_study_id

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