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

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ClinicalTrials.gov Identifier: NCT02848716
Recruitment Status : Not yet recruiting
First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Muriel POUBLANC, Institut Claudius Regaud

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.

Condition or disease Intervention/treatment Phase
Overall Survival Comparison Between the 2 Arms Procedure: Surgery followed with chemoradiation Radiation: Standard chemoradiation Radiation: chemoradiation Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Study of Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Dispositioned to Definitive Chemoradiotherapy
Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: Standard of care arm
Standard chemoradiation based on FluoroDeoxyGlucose-Positon Emission Tomography (FDG-PET) imaging status of the pelvic nodes
Radiation: Standard chemoradiation

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.


Radiation: chemoradiation
Experimental: Experimental arm
Pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach
Procedure: Surgery followed with chemoradiation

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.





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848716


Contacts
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Contact: Alejandra Martinez, Dr 33 (0)5 31 15 53 66 martinez.alejandra@iuct-oncopole.fr
Contact: Muriel Mounier 33 (0)5 31 15 58 58 mounier.muriel@iuct-oncopole.fr

Sponsors and Collaborators
Muriel POUBLANC
Investigators
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Principal Investigator: Alejandra Martinez, Dr Institut Claudius Regaud

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Responsible Party: Muriel POUBLANC, Dr Alejandra MARTINEZ, Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT02848716     History of Changes
Other Study ID Numbers: 10 GENF 04
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Specific Case Report Form (CRF)
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female