Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer (NCT05880485) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Online Adaptive Radiotherapy Cervical Cancer With Reduced Margin for Cervical Cancer
China30 participantsStarted 2023-02-02
Plain-language summary
Online adaptive radiotherapy (oART) has demonstrated to be feasible to reduce planning target volume (PTV) margins for cervical cancer. To explore the value of reduced margins in oART for cervical cancer, we conducted a prospective clinical trial to determine the clinical efficacy and toxicity of reduced margins.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
. Age ≥18 years and ≤ 75 years.
. Patients with newly histologically confirmed cervical cancer, including squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma, et al.
. No evidence of para-aortic metastatic lymph nodes (MLNs) and inguinal lymph nodes on CT, MRI or positron emission tomograph (PET)/CT.
. No contraindications to CT scanning.
. No evidence of distant metastasis (FIGO stage IVB).
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patient-reported acute toxicity
Timeframe: From the start of treatment to 3 months after treatment
2
Physician-reported acute toxicity
Timeframe: From the start of treatment to 3 months after treatment
. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).
Exclusion criteria
. With common iliac MLNs.
. Tumor extended to the lower third of the vagina.
. Tumor spread to mucosa of the bladder or rectum.
. Prior surgery (including pelvic or para-aortic lymph nodes resection, except for tumor biopsy), radiotherapy or chemotherapy to primary tumor or nodes.
. Prior malignancy.
. History of previous radiotherapy to the abdomen or pelvis.
. Pregnancy or lactation.
. Active inflammatory bowel disease, or history of severe stomach or duodenal ulcer.