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

NCT04139967 | Terminated DMC

• 1 other identifier: 4297
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer, Rectal

Outcome Measures

Primary Outcomes (2)

• Progression-free survival

  Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.

  5 years

• Number of participants who experience a grade 2 adverse event

  CTCAE V4.0 will be used to determine the grade 2 AE.

  week 5

Secondary Outcomes (5)

• Number of participants who received surgery for their cancer

  5 years

• Number of participant who experience metastatic disease

  5 years

• Change in Mean quality of life

  baseline to 24 months

• Change in Mean functional status

  baseline to 24 months

• Number of participants with improved symptoms

  5 years

Study Arms (1)

Elderly rectal cancer patients

EXPERIMENTAL

Radiation: Short course radiation therapy

Interventions

Short course radiation therapy RADIATION

25 Gray in 5 fractions over 5-7 days

Elderly rectal cancer patients

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

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

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: January 20, 2020
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)