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Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread

NCT03534713 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2023-09-21

No results posted yet for this study

Summary

The main objective of this study is to determine whether neoadjuvant chemotherapy with Carboplatin and paclitaxel plus standard cisplatin-based chemoradiation with extended fields improves overall survival rates compared to standard therapy alone in women with cervical cancer with paraaortic lymph node involvement.

Women in the experimental arm will receive neoadjuvant chemotherapy with carboplatin and paclitaxel every 21 days during 3 cycles followed by standard therapy with extended field external radiation therapy and concomitant chemotherapy. Women in the control arm will receive standard therapy with extended field external radiation therapy and concomitant chemotherapy.

310 patients will be recruited during 4.5 years, with 3 years of follow up period.

Conditions

  • Cervical Cancer TNM Staging Regional Lymph Nodes (N)

Interventions

DRUG

Carboplatin

carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles

DRUG

Paclitaxel

paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles

DRUG

Cisplatin

Cisplatin 40mg/m² given once a week during 5 weeks

RADIATION

Radiotherapy

45 gray to the pelvis and para aortic area over 5 weeks + intracavitary brachytherapy alone or prior to surgery, depending on response to treatment according to the current guidelines

Sponsors & Collaborators

  • Institut Claudius Regaud

    collaborator OTHER

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Stéphanie MOTTON, MD · University Hospital, Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-17
Primary Completion
2026-09-30
Completion
2026-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT03534713 on ClinicalTrials.gov