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

NCT02848716 | Withdrawn Phase 3 DMC

• 1 other identifier: 10 GENF 04
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overall Survival Comparison Between the 2 Arms

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 10 years

Study Arms (2)

Standard of care arm

ACTIVE COMPARATOR

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

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

Procedure: Surgery followed with chemoradiation

Interventions

Surgery followed with chemoradiation PROCEDURE

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.

Experimental arm

Standard chemoradiation RADIATION

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.

Standard of care arm

chemoradiation RADIATION

Standard of care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muriel POUBLANC: lead

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Alejandra Martinez, Dr

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr Alejandra MARTINEZ

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share