Phase 3
N=28
Extraperitoneal Para-aortic Lymph Node Dissection (EPLND) for Cervix
Cervical Squamous Cell Carcinoma · Adenosquamous Carcinoma · Adenocarcinoma · Locally Advanced Malignant Neoplasm · Cervical Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01365156 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Overall Survival Rate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Extraperitoneal laparoscopic lymphadenectomy (EPLND) (Procedure); Chemoradiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival Rate |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Women with clinical stage IB2-IVA cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
- Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes and negative paraaortic nodes.
- Women with planned treatment of primary definitive chemoradiation therapy.
- Patient information and written informed consent form signed.
- Age >/= 18 years old
- ECOG Performance Status (PS) /= 3 months
Exclusion Criteria
- Women with stage IA or IB1 cancer.
- Women with prior radiotherapy to the pelvis or retroperitoneal surgery.
- Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma.
- Women with FDG PETpositive high common or paraaortic lymph node metastasis confirmed by biopsy.
- Women who have undergone simple or radical hysterectomy prior to radiotherapy.
- Women with planned treatment of radiotherapy only (without chemotherapy).
- Women with planned treatment of palliative radiotherapy.
- Women with metastatic disease outside of pelvis.
- Women who have completed treatment for other malignancies (except non-melanomatous skin cancer) < 5 years from their new diagnosis of cervical cancer.
- Women who are pregnant, women who are likely to be pregnant or are breastfeeding.
- 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.
- (French Sites Only) Women not affiliated with Social Security System in France.
- (French Sites Only) Women deprived of liberty or under guardianship.
Data sourced from ClinicalTrials.gov (NCT01365156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.