Radiation technique sparing the anal canal in women with cervical cancer and hemorrhoids
Tests a radiation method that spares the anal canal in cervical cancer patients with hemorrhoids.
Plain-language title generated from the registry record
Registry title: A Clinical Study on Alleviating Hemorrhoids-related Symptoms of Pelvic Radiation Therapy
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer and a history of hemorrhoids who have had a hysterectomy and need pelvic radiation with chemotherapy afterwards. It tests a way of radiating that spares the anal canal.
- Age
- Older than 18 years (minimum age listed: 19 Years).
- Sex
- Women only.
- Disease stage
- Cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) treated with hysterectomy within 6 weeks before the study, needing chemotherapy together with radiation afterwards. No distant spread.
- Earlier treatment
- Hysterectomy within 6 weeks before the study. No earlier pelvic radiation with overlapping radiation fields.
Main reasons for not taking part
- No confirmed history of hemorrhoids
- Cannot have an MRI, or refuses the anal canal MRI
- Visible leftover tumor after surgery that needs an extra radiation boost
- History of other cancers
- Allergic reaction to platinum-based chemotherapy drugs
Read by machine on 9 November 2026.
Where in China
- Shanghai General HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Trial code
- NCT07175584
- Record updated
- 22 September 2025
- Original description
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.Read full original descriptionShow less
Anal Canal-Sparing Technique During Postoperative Pelvic Radiation Therapy for Cervical Cancer Patients to Reduce Hemorrhoids-related Symptoms: A Multicenter Randomized Clinical Trial
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.
Inclusion: 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; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; History of hemorrhoids prior to radiotherapy, with no hemorrhoid-related symptoms for at least 4 weeks before radiation therapy initiation; Abdominal/pelvic MRI, chest CT, or PET-CT performed before surgery or study enrollment to confirm staging and exclude patients with distant metastasis; Adequate bone marrow, renal, and hepatic function; Agreement to undergo anal canal MRI before radiation therapy initiation; Patient must provide study-specific informed consent form (ICF) prior to study entry.
Exclusion: Prior pelvic radiotherapy resulting in overlapping radiation fields; Severe and/or active comorbidities precluding tolerance of concurrent chemoradiotherapy; 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 with radiographically visible residual disease post-surgery requiring boost during the pelvic EBRT; History of other malignancies; History of allergic reaction to platinum-based chemotherapy agents; Patients who refuse to undergo anal canal MRI.