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

Cancer, Rectal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04139967
• Other study ID #: 4297
• Status: Terminated
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: August 3, 2022

Study information

• Verified date: July 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer, Rectal
• Rectal Neoplasms

Intervention

Radiation:
• Short course radiation therapy
25 Gray in 5 fractions over 5-7 days

Locations

Country	Name	City	State
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.	5 years
Primary	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	Number of participants who received surgery for their cancer		5 years
Secondary	Number of participant who experience metastatic disease	MRI or endoscopy will be used to track metastasis to other parts of the body	5 years
Secondary	Change in Mean quality of life	Quality of life will be assessed using the Low Anterior Resection Syndrome Score Questionnaire. Scores range from 0-42 points with higher scores indicating worse outcome.	baseline to 24 months
Secondary	Change in Mean functional status	Quality of life will be assessed using the Low Anterior Resection Syndrome Score Questionnaire. Scores range from 0-42 points with higher scores indicating worse outcome.	baseline to 24 months
Secondary	Number of participants with improved symptoms	Symptoms will be documented by the treating physician at each clinical visit for 5 years.	5 years