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

Primary Purpose

Overall Survival Comparison Between the 2 Arms

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Surgery followed with chemoradiation

Standard chemoradiation

chemoradiation

About this trial

This is an interventional treatment trial for Overall Survival Comparison Between the 2 Arms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care arm

Experimental arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall survival

A Positon Emission Tomography (PET) scan will be obtained at 3 months after completion of chemoradiation therapy. CT scans will be obtained every 6 months for the next three years thereafter. Follow-up surveillance of patients will consist of serial clinical examinations by an oncologist every 3 months for the first 2 years, every 6 months for the next 3 years; then, patients will be followed annually only for collection of their survival data. Patients will come off study at 5 years after completion of initial chemoradiation therapy or at time of death.

Secondary Outcome Measures

Full Information

NCT ID

NCT02848716

First Posted

July 26, 2016

Last Updated

November 10, 2021

Sponsor

Muriel POUBLANC

1. Study Identification

Unique Protocol Identification Number

NCT02848716

Brief Title

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

Acronym

LiLACs

Official Title

A Phase III Randomized Study of Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Study cancelled due to operational difficulties

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Muriel POUBLANC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overall Survival Comparison Between the 2 Arms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of care arm

Arm Type

Active Comparator

Arm Description

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

Arm Title

Experimental arm

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Surgery followed with chemoradiation

Intervention Description

Patients with negative paraaortic lymph nodes will be managed with external beam radiotherapy to the pelvis (as defined by the surgical clips applied at the lower limit of the paraaortic node dissection) at a usual dose of 45 Gy. Limited boosts will be indicated individually on clinically involved parametria or pelvic nodes. The external beam radiation therapy will be followed by intracavitary brachytherapy (High Dose Rate (DR), Low DR or Pulse DR) with intent to cure. Patients with metastatic disease to paraaortic lymph nodes will receive extended-field external beam radiotherapy followed by intracavitary brachytherapy with intent to cure. Patients who complete both external beam radiation and intracavitary radiotherapy will receive a total dose of 80-90 Gy low-dose equivalent to Point A. Concurrent platinum-based chemotherapy (in the 2 sub groups above) will be given with definitive radiation therapy.

Intervention Type

Radiation

Intervention Name(s)

Standard chemoradiation

Intervention Description

patients with negative paraaortic lymph nodes on PET imaging will be managed with external beam radiotherapy to the pelvis at a usual dose of 45 Gy. Limited boosts will be indicated individually on clinically involved parametria or pelvic nodes. The external beam radiation therapy will be followed by intracavitary brachytherapy with intent to cure (HDR, LDR or PDR). Patients who complete both external beam radiation and intracavitary radiotherapy will receive a total dose of 80-90 Gy low-dose equivalent to Point A. Concurrent platinum-based chemotherapy will be given with definitive radiation therapy.

Intervention Type

Radiation

Intervention Name(s)

chemoradiation

Primary Outcome Measure Information:

Title

Overall survival

Description

Time Frame

up to 10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women with clinical stage from 1B2 to 4A cervical squamous cell carcinoma, adenosquamous, or adenocarcinoma. Women with FDG-PET positive or indeterminate pelvic lymph nodes or indeterminate low common iliac nodes (see addendum below) 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. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2. Life expectancy ≥ 3 months. Exclusion Criteria: Women with stage 1A or 1B1 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 PET positive high common / paraaortic lymph node metastasis confirmed by biopsy (see addendum below). 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. Women not affiliated with Social Security System in France. Women deprived of liberty or under guardianship.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alejandra Martinez, Dr

Organizational Affiliation

Institut Claudius Regaud

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Specific Case Report Form (CRF)

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

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