Cancer, RectalNCT04139967
Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
A study testing Short course radiation therapy in people with Cancer, Rectal, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer, Rectal
- What is being tested?
- Short course radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 3 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Age under 70 years of age
- Ability and desire to receive definitive surgical intervention
- Ability and desire to receive concurrent chemoradiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
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
- Being tested
- Short course radiation therapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short course radiation therapyRadiation
25 Gray in 5 fractions over 5-7 days
| Study group | Role | What they receive |
|---|---|---|
| Elderly rectal cancer patients | Experimental | Not described Receives: Radiation: Short course radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.
Measured: 5 years
Number of participants who experience a grade 2 adverse event
CTCAE V4.0 will be used to determine the grade 2 AE.
Measured: week 5
Secondary outcomes (5)
Number of participants who received surgery for their cancer
Measured: 5 years
Number of participant who experience metastatic disease
MRI or endoscopy will be used to track metastasis to other parts of the body
Measured: 5 years
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.
Measured: baseline to 24 months
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.
Measured: baseline to 24 months
Number of participants with improved symptoms
Symptoms will be documented by the treating physician at each clinical visit for 5 years.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start20 Jan 2020
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Why it stopped: recruitment rates were too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer, RectalStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haoming (Carl) Qiu, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139967
- Sponsor's protocol ID
- 4297
- Status last verified
- Jul 2023
- First submitted
- 23 Oct 2019
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Short Course Radiation Therapy for Elderly Patients With Rectal Cancer
- ClinicalTrials.gov ID
- NCT04139967
- Acronym / sponsor ID
- 4297
- Conditions
- Cancer, Rectal
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment rates were too low
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly rectal cancer patients | Experimental | Radiation: Short course radiation therapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Age under 70 years of age
- Ability and desire to receive definitive surgical intervention
- Ability and desire to receive concurrent chemoradiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short course radiation therapy25 Gray in 5 fractions over 5-7 days | Radiation | Elderly rectal cancer patients |
Primary outcome
Progression-free survival
Time frame: 5 years
Progression will be defined as Radiologic response from MRI or CT scans using RECIST v1.1 criteria.
Number of participants who experience a grade 2 adverse event
Time frame: week 5
CTCAE V4.0 will be used to determine the grade 2 AE.
5 secondary outcomes
Number of participants who received surgery for their cancer
Time frame: 5 years
Number of participant who experience metastatic disease
Time frame: 5 years
Change in Mean quality of life
Time frame: baseline to 24 months
Change in Mean functional status
Time frame: baseline to 24 months
Number of participants with improved symptoms
Time frame: 5 years
Results and safety
The study was stopped early (reason given: recruitment rates were too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short course radiation therapy in people with Cancer, Rectal, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment rates were too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.