The goal of this clinical trial is to reduce the acute hemorrhoids-related symptoms for cervical cancer patients with hemorrhoids who need postoperative pelvic radiation therapy, including prolapse, local burning, bleeding, perianal pain, and other perianal discomforts.
The main questions it aims to answer are:
Will anal canal-sparing technique improve the quality of life for cervical cancer patients with hemorrhoids during pelvic radiation therapy? Will the radiation dose exposure to anal canal be reduced through anal canal-sparing technique?
Researchers will compare the aggravation of radiation-induced hemorrhoids-related symptoms occurring from the initiation of pelvic radiation therapy until 4 weeks after its completion. Conventional postoperative treatment regimens will not be changed and researchers will only reduce the irradiated dose to anal canal which should be protected during pelvic radiation therapy.
Participants will be randomly assigned with equal probability (1:1 ratio) to either: control group (conventional postoperative pelvic radiation therapy) and intervention group (anal canal-sparing pelvic radiation therapy), in either combined with brachytherapy or not. Following randomization, participants will not be informed of their group assignment until completion of the follow-up period.
Notice: The treatment efficacy will not be compromised by group assignment. No additional treatment-related adverse effects will occur due to study participation. The intervention group may potentially mitigate radiotherapy-induced adverse effects.
Treated with hysterectomy (including total abdominal hysterectomy, vaginal hysterectomy, radical hysterectomy, or laparoscopically assisted vaginal hysterectomy) within 6 weeks prior to study initiation.
Histologically proven diagnosis of cervical carcinoma, including squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
Requirement for postoperative adjuvant concurrent chemoradiotherapy (CCRT).
Age > 18 years.
Cervical cancer patients who do not meet the criteria for adjuvant radiation therapy.
Without a confirmed history of hemorrhoids.
Patients contraindicated for MRI (e.g., due to incompatible metallic implants, claustrophobic syndrome, or other contraindications).
Patients who refuse to undergo anal canal MRI.
Parallel
anal canal-sparing techniques
RadiationTo contour anal canal and rectum separately and deliver different doses as two single OARs in pelvic radiation therapy planning.
The incidence of radiation-induced hemorrhoid-related symptoms
Click on the lead sponsor to view all of their trials.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead sponsor
RenJi Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
Changzhou Cancer Hospital of Soochow University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
