Effects of Different Radiation Dosimetry for Anorectal Function of Patients With Pelvic Cancer

NCT05832385 | Not Yet Recruiting

• 1 other identifier: 2023ZSLYEC-039
• Study Type: observational
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Anorectal Cancer

Outcome Measures

Primary Outcomes (1)

• the average resting pressure of anal sphincter

  High-resolution anorectal manometry will be used to assess the average resting pressure and maximal contraction pressure.

  2023.05-2026.05

Secondary Outcomes (2)

• maximum anal sphincter contraction pressure

  2023.05-2026.05

• Wexner continence score

  2023.05-2026.05

Study Arms (2)

radiation dose≤50Gy

rectal cancer with IMRT radiation dose≤50Gy

radiation dose>50Gy

anal cancer with IMRT radiation dose\>50Gy

Radiation: IMRT

Interventions

IMRT RADIATION

anal cancer: chemoradiotherapy, radiation dose\>50Gy; rectal cancer: chemoradiotheray, radiation dose=50Gy

Also known as: chemotherapy

radiation dose>50Gy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice chief of department of anus and intestine surgery

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 27, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 27, 2023

Record last verified: 2023-04