Pretherapeutic Paraaortic Lymphadenectomy in Women With Locally Advanced Cervical Cancer Versus Definitive Chemoradiotherapy
NCT ID: NCT02848716
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2016-12-31
2026-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of care arm
Standard chemoradiation based on FluoroDeoxyGlucose-Positon Emission Tomography (FDG-PET) imaging status of the pelvic nodes
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.
chemoradiation
Experimental arm
Pretherapeutic paraaortic lymphadenectomy followed by tailored chemoradiation. Pretherapeutic lymphadenectomy will be performed via the laparoscopic extraperitoneal or transperitoneal approach
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.
Interventions
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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.
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.
chemoradiation
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Muriel POUBLANC
OTHER
Responsible Party
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Muriel POUBLANC
Dr Alejandra MARTINEZ
Principal Investigators
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Alejandra Martinez, Dr
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius Regaud
Other Identifiers
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10 GENF 04
Identifier Type: -
Identifier Source: org_study_id