Clinical trial · Interventional
A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer
Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
- 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)
Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate.
Conditions
Conditions (3)
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 |
| Lymphocyst | — | UNRESOLVED | — |
| Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Radiation Method A | Radiation | — | UNRESOLVED |
| Radiation Method B | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The control group (Group A)
- description
- In Group A, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
- interventionNames
- Drug: Cisplatin
- Radiation: Radiation Method A
- type
- EXPERIMENTAL
- label
- The experiment group (Group B)
- description
- In Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
- interventionNames
- Radiation: Radiation Method B
- Drug: Cisplatin
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pathological diagnosed cervical cancer and treated with radical resection * Stage I-II diseases (FIGO system ver. 2014) * Karnofsky Performance Scores ≥ 80 and expected survival ≥ 3 months * Pelvic MRI or CT indicate existence of lymphocyst * Need of adjuvant radiotherapy according to NCCN guidelines ver. 2016v2 (SEDLIS criteria) Exclusion Criteria: * Patients with distant metastasis before or during radiotherapy * Severe dysfunction of heart, lung, liver, kidney or hematopoietic system * Severe neurological, mental or endocrine diseases * History of other malignancies * Prior chemotherapy, radiotherapy or application of monoclonal antibodies * Patients participated in clinical trials of other drugs within last 3 months * Pregnant or lactating women * Those who are considered by the researchers unsuitable to participate
References
Publications (0)
Data not yet available