Prophylactic irradiation for advanced cervical cancer
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
This study is testing if adding a specific type of radiation treatment to standard therapy can help women with advanced cervical cancer live longer without their disease coming back.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 455 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Hangzhou, Zhejiang and 6 other locations) |
| Trial ID | NCT04974346 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of para-aortic prophylactic radiotherapy in improving disease-free survival for patients with locally advanced cervical cancer who have positive pelvic lymph nodes. Participants will be randomly assigned to receive either para-aortic and pelvic radiotherapy combined with concurrent chemotherapy or pelvic radiotherapy alone with concurrent chemotherapy. The study aims to determine if the addition of para-aortic irradiation can lead to better outcomes compared to standard treatment. The trial includes women aged 18-75 with specific cancer types and staging criteria.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-75 with locally advanced cervical cancer and positive pelvic lymph nodes diagnosed by PET-CT.
Not a fit: Patients with uncontrolled severe infections or other concurrent malignant tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve disease-free survival rates for patients with locally advanced cervical cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The patients voluntarily participated in the study and signed the informed consent * 18-75 female * Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma * According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT * Cisplatin chemotherapy is acceptable * Eastern Cooperative Oncology Group(ECOG) score 0-1 * The expected survival was more than 6 months * Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test * According to the judgment of the researcher, those who can comply with the trial protocol Exclusion Criteria: * Uncontrolled severe infection * Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years * The patient has received anti-tumor treatment * Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure * History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease * Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification) * Patients with previous pelvic artery embolization * Previous radiotherapy for pelvic malignant tumor * There was a history of severe allergic reaction to platinum containing chemotherapy drugs * Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis * The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent * Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study
Where this trial is running
Hangzhou, Zhejiang and 6 other locations
- Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, China (Active_not_recruiting)
- Jinhua Municipal Central Hospital Medical Group — Jinhua, China (Active_not_recruiting)
- Lishui People's Hospital — Lishui, China (Active_not_recruiting)
- Ningbo First Hospital — Ningbo, China (Active_not_recruiting)
- Taizhou Central Hospiatl — Taizhou, China (Active_not_recruiting)
- Chongqing University Three Gorges Hospital — Wanzhou, China (Active_not_recruiting)
Study contacts
- Study coordinator: Xiang Zhang
- Email: zhangxiang@zjcc.org.cn
- Phone: 0086-571-88122148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.