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

NCT02848716 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-11-17

No results posted yet for this study

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.

Conditions

  • Overall Survival Comparison Between the 2 Arms

Interventions

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.

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

Sponsors & Collaborators

  • Muriel POUBLANC

    lead OTHER

Principal Investigators

  • Alejandra Martinez, Dr · Institut Claudius Regaud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02848716 on ClinicalTrials.gov