Overall Survival Comparison Between the 2 ArmsPhase 3LiLACsNCT02848716
Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Versus Definitive Chemoradiotherapy
A Phase 3 study testing Surgery followed with chemoradiation, Standard chemoradiation and chemoradiation in people with Overall Survival Comparison Between the 2 Arms, run by Muriel POUBLANC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overall Survival Comparison Between the 2 Arms
- What is being tested?
- Surgery followed with chemoradiation, Standard chemoradiation and chemoradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
Official title: A Phase III Randomized Study of Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
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.
Read the 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.
- Being tested
- Surgery followed with chemoradiation, Standard chemoradiation, chemoradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery followed with chemoradiationProcedure or surgery
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.
Standard chemoradiationRadiation
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.
chemoradiationRadiation
| Study group | Role | What they receive |
|---|---|---|
| Standard of care arm | Active comparator | Standard chemoradiation based on FluoroDeoxyGlucose-Positon Emission Tomography (FDG-PET) imaging status of the pelvic nodes Receives: Radiation: Standard chemoradiation; Radiation: chemoradiation |
| Experimental arm | Experimental | Pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach Receives: Procedure: Surgery followed with chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: Study cancelled due to operational difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overall Survival Comparison Between the 2 ArmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muriel POUBLANC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muriel POUBLANC, Institut Claudius Regaud
- Investigators
- Alejandra Martinez, Dr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848716
- Sponsor's protocol ID
- 10 GENF 04
- Acronym
- LiLACs
- Status last verified
- Nov 2021
- First submitted
- 26 Jul 2016
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Specific Case Report Form (CRF)
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study of Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT02848716
- Acronym / sponsor ID
- LiLACs / 10 GENF 04
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study cancelled due to operational difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Muriel POUBLANCUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care arm | Active comparator | Radiation: Standard chemoradiation, Radiation: chemoradiationStandard chemoradiation based on FluoroDeoxyGlucose-Positon Emission Tomography (FDG-PET) imaging status of the pelvic nodes |
| Experimental arm | Experimental | Procedure: Surgery followed with chemoradiationPretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery followed with chemoradiationPatients 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. | Procedure or surgery | Experimental arm |
| Standard chemoradiationpatients 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. | Radiation | Standard of care arm |
| chemoradiation | Radiation | Standard of care arm |
Primary outcome
Overall survival
Time frame: up to 10 years
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Individual participant dataSharing planned: Yes. Specific Case Report Form (CRF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandra Martinez, Dr principal investigator
Institut Claudius Regaud
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery followed with chemoradiation, Standard chemoradiation and chemoradiation in people with Overall Survival Comparison Between the 2 Arms, run by Muriel POUBLANC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.