Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Versus Definitive Chemoradiotherapy (LiLACs)

Muriel POUBLANC

Status and phase: Withdrawn; Phase 3

Conditions: Overall Survival Comparison Between the 2 Arms

Treatments: Radiation: chemoradiation; Radiation: Standard chemoradiation; Procedure: Surgery followed with chemoradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02848716

10 GENF 04

Details and patient eligibility

About

This is an international, prospective, multicenter and randomized phase III study designed to determine if patients with locally advanced cervical cancer have longer overall survivals with pretherapeutic paraaortic surgical staging when compared to radiologic staging.

Full description

All eligible patients will be equally randomized between the 2 following treatment groups:

• Standard of care arm: standard chemoradiation (whole pelvis chemoradiation therapy).
• Experimental arm: pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach using either traditional laparoscopy or robotically-assisted laparoscopy.

The surgery (extraperitoneal or transperitoneal laparoscopic lymphadenectomy) is considered investigational.

Chemoradiation treatment (with either pelvis or tailored radiation) is considered as standard treatment approved in France for the treatment of cervical cancer.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women with clinical stage from 1B2 to 4A cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma.
2. Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes (see addendum below) 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. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
7. Life expectancy ≥ 3 months.

Exclusion criteria

1. Women with stage 1A or 1B1 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 PET positive high common / paraaortic lymph node metastasis confirmed by biopsy (see addendum below).
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. Women not affiliated with Social Security System in France.
13. Women deprived of liberty or under guardianship.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard of care arm

Active Comparator group

Description:

Standard chemoradiation based on FluoroDeoxyGlucose-Positon Emission Tomography (FDG-PET) imaging status of the pelvic nodes

Treatment:

Radiation: Standard chemoradiation

Radiation: chemoradiation

Experimental arm

Experimental group

Description:

Pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach

Treatment:

Procedure: Surgery followed with chemoradiation