Clinical trial · Interventional
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer
Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study
NCT04974346CI-TRIAL-00056118PAILACCrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation | Radiation | — | UNRESOLVED |
| Pelvic definitive concurrent chemoradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- study arm
- description
- External beam radiotherapy: Pelvic and para-aortic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy. Concurrent chemotherapy: Weekly cisplatin 40mg/m2 during external beam radiotherapy. Brachytherapy: High dose rate(HDR) Brachytherapy. The dose of high-risk clinical target volume(HR CTV) D90 or Point A should be 85Gy+/-10%. The dose of intermediate-risk clinical target volume(IR CTV) D98 should be 60Gy at least.
- interventionNames
- Radiation: Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- External beam radiotherapy: Pelvic radiotherapy 45-50.4Gy/25-28 fractions. PET-CT positive lymph node should be boost to a dose of 60Gy or higher. Parametrium(both) should be boost to a dose from 50Gy to 60Gy. Concurrent chemotherapy: Weekly cisplatin 40mg/m2 during external beam radiotherapy. Brachytherapy: HDR Brachytherapy. The dose of HR CTV D90 or Point A should be 85Gy+/-10%. The dose of IR CTV D98 should be 60Gy at least.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.