Clinical trial · Interventional
Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix
A Phase III Randomized Study of Pretherapeutic Para-aortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
NCT01365156CI-TRIAL-00049824completedPhase 3Results postedClinicalTrials.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)
The goal of this clinical research study is to learn if a surgical procedure called an extraperitoneal laparoscopic lymphadenectomy followed by chemotherapy and tailored radiation therapy can help to control the disease for a longer time than standard-of-care chemotherapy and whole pelvic radiation therapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Adenosquamous Carcinoma | Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.90 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiation | Radiation | — | UNRESOLVED |
| Extraperitoneal laparoscopic lymphadenectomy (EPLND) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EPLND + Chemoradiation
- description
- Group 1: Extraperitoneal laparoscopic lymphadenectomy followed by chemoradiation therapy
- interventionNames
- Procedure: Extraperitoneal laparoscopic lymphadenectomy (EPLND)
- Radiation: Chemoradiation
- type
- ACTIVE_COMPARATOR
- label
- Chemoradiation
- description
- Group 2: standard-of-care chemoradiation therapy only
- interventionNames
- Radiation: Chemoradiation
Primary outcomes (1)
- measure
- Overall Survival Rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma. 2. Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes. 3. Women with planned treatment of primary definitive chemoradiation therapy. 4. Patient information and written informed consent form signed. 5. Age \>/= 18 years old 6. ECOG Performance Status (PS) \</= 2 7. Life Expectancy \>/= 3 months Exclusion Criteria: 1. Women with stage IA or IB1 cancer. 2. Women with prior radiotherapy to the pelvis or retroperitoneal surgery. 3. Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma. 4. Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy. 5. Women who have undergone simple or radical hysterectomy prior to radiotherapy. 6. Women with planned treatment of radiotherapy only (without chemotherapy). 7. Women with planned treatment of palliative radiotherapy. 8. Women with metastatic disease outside of pelvis. 9. Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) \< 5 years from their new diagnosis of cervical cancer. 10. Women who are pregnant, women who are likely to be pregnant or are breastfeeding. 11. Women with any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety, provision of informed consent or compliance to study procedures. 12. (French Sites Only) Women not affiliated with Social Security System in France. 13. (French Sites Only) Women deprived of liberty or under guardianship.
References
Publications (0)
Data not yet available
No reference posted for this study.