Anorectal CancerNCT05832385
Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer
An observational study of Anorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
In this prospective, open, multicenter, multi-arm, observational controlled study, the investigators investigated the impact of different pelvic radiation doses of anal cancer and rectal cancer patients on the dynamic changes of anal function, and analyzed the correlation between the changes of anal function and the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anorectal Cancer
- What is being tested?
- IMRT
- Type of treatment
- Surgery or procedure
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2023to 30 May 2026
- Phase
- Observational
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with anal and rectal cancer at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University will be assessed for suitability for inclusion.
Inclusion criteria 18-75 years of age. Anal cancer and rectal cancer with pathological diagnosis. Patient will undergo sphincter-preserving therapies. Eastern Cooperative Oncology Group (ECOG) score for performance status is 0-2. Written informed consent. Exclusion criteria Patients who have undergone pelvic surgery, such as rectal cancer surgery and gynaecological procedures. Patients who have received pelvic radiotherapy. Patients with other active malignant tumors. Patients with a history of prior peri-anal abscess, anorectal trauma, and inflammatory bowel disease (IBD).
Recently (less than 4 weeks) received surgery or patients with recent severe trauma.
Significant cardiac disease: congestive heart failure of New York Heart Association class ≥2; patients with recent (less than 12 months) active coronary artery disease (unstable angina or myocardial infarction).
Recent (less than 6 months) thrombosis or embolism events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism and deep vein thrombosis.
Patients with toxicity (Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2) caused by previous treatment that has not subsided.
Women who suffered anal sphincter tear after vaginal delivery. Pregnant or lactating women.
About this study
Official title: Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer: a Study Protocol for a Prospective, Observational, Controlled, Multicenter Study
In this prospective, open, multicenter, multi-arm, observational controlled study, the investigators investigated the impact of different pelvic radiation doses of anal cancer and rectal cancer patients on the dynamic changes of anal function, and analyzed the correlation between the changes of anal function and the score of anal incontinence in the radiation dose≤50Gy group and >50Gy group. The study population includes 124 patients with anal canal cancer or rectal cancer who have received sphincter preservation treatments (including radiochemotherapy), aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University. The primary outcome is the average resting pressure of anal sphincter. The secondary outcomes are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years.
- Conditions
- Anorectal Cancer
- Being tested
- IMRT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRTRadiation
Also called chemotherapy
anal cancer: chemoradiotherapy, radiation dose>50Gy; rectal cancer: chemoradiotheray, radiation dose=50Gy
| Study group | Role | What they receive |
|---|---|---|
| radiation dose≤50Gy | rectal cancer with IMRT radiation dose≤50Gy | |
| radiation dose>50Gy | anal cancer with IMRT radiation dose>50Gy Receives: Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
the average resting pressure of anal sphincter
High-resolution anorectal manometry will be used to assess the average resting pressure and maximal contraction pressure.
Measured: 2023.05-2026.05
Secondary outcomes (2)
maximum anal sphincter contraction pressure
High-resolution anorectal manometry will be used to assess the average resting pressure and maximal contraction pressure.
Measured: 2023.05-2026.05
Wexner continence score
Wexner continence score 0-20, higher means worse
Measured: 2023.05-2026.05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start15 May 2023 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongcheng Lin, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832385
- Sponsor's protocol ID
- 2023ZSLYEC-039
- Status last verified
- Apr 2023
- First submitted
- 14 Feb 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer: a Study Protocol for a Prospective, Observational, Controlled, Multicenter Study
- ClinicalTrials.gov ID
- NCT05832385
- Acronym / sponsor ID
- 2023ZSLYEC-039
- Conditions
- Anorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 27 Apr 2023 (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.
In this prospective, open, multicenter, multi-arm, observational controlled study, the investigators investigated the impact of different pelvic radiation doses of anal cancer and rectal cancer patients on the dynamic changes of anal function, and analyzed the correlation between the changes of anal function and the score of anal incontinence in the radiation dose≤50Gy group and >50Gy group. The study population includes 124 patients with anal canal cancer or rectal cancer who have received sphincter preservation treatments (including radiochemotherapy), aged from 18 to 75 years old undergoing sphincter preservation treatments at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University. The primary outcome is the average resting pressure of anal sphincter. The secondary outcomes are maximum anal sphincter contraction pressure and Wexner continence score. Evaluations will be carried out at the following stages: baseline (T1), after radiotherapy or chemotherapy (before surgery, T2), after surgery (before closing the temporary stoma, T3), and at follow-up visits (every 3 to 6 months, T4, T5……). Follow-up for each patient will be at least 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiation dose≤50Gy | – | –rectal cancer with IMRT radiation dose≤50Gy |
| radiation dose>50Gy | – | Radiation: IMRTanal cancer with IMRT radiation dose>50Gy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with anal and rectal cancer at The Sixth Affiliated Hospital, Sun Yat-sen University and Nanfang Hospital, Southern Medical University will be assessed for suitability for inclusion.
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 |
|---|---|---|
| IMRTAlso: chemotherapyanal cancer: chemoradiotherapy, radiation dose>50Gy; rectal cancer: chemoradiotheray, radiation dose=50Gy | Radiation | radiation dose>50Gy |
Primary outcome
the average resting pressure of anal sphincter
Time frame: 2023.05-2026.05
High-resolution anorectal manometry will be used to assess the average resting pressure and maximal contraction pressure.
2 secondary outcomes
maximum anal sphincter contraction pressure
Time frame: 2023.05-2026.05
Wexner continence score
Time frame: 2023.05-2026.05
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
the average resting pressure of anal sphincter (time frame: 2023.05-2026.05). 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 27 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.