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Trial Title:
Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer
NCT ID:
NCT05832385
Condition:
Anorectal Cancer
Conditions: Official terms:
Pelvic Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Radiation
Intervention name:
IMRT
Description:
anal cancer: chemoradiotherapy, radiation dose>50Gy; rectal cancer: chemoradiotheray,
radiation dose=50Gy
Arm group label:
radiation dose>50Gy
Other name:
chemotherapy
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 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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 15, 2023
Completion date:
May 30, 2026
Lead sponsor:
Agency:
Sixth Affiliated Hospital, Sun Yat-sen University
Agency class:
Other
Source:
Sixth Affiliated Hospital, Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05832385
