Actively Recruiting
Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
Led by University Hospital, Toulouse · Updated on 2023-09-21
310
Participants Needed
11
Research Sites
332 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Toulouse
Lead Sponsor
I
Institut Claudius Regaud
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with invasive cervical cancer and paraaortic lymph node involvement confirmed by PET-CT or histology
- Performance status Eastern Cooperative Oncology Group 0 to 2
- Stage IB1 to IVA cervical cancer at diagnosis with paraaortic lymph node spread
- Histology of adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma
- Adequate kidney function (creatinine clearance 60 mL/min)
- Adequate liver function (bilirubin less than 1.5 times normal, SGOT less than 3 times normal)
- Adequate blood counts (platelets above 100 x 10^9/L, neutrophils above 1.5 x 10^9/L)
- Signed informed consent to participate
You will not qualify if you...
- Stage IVB cervical cancer at diagnosis
- Histologies other than adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma
- Prior chemotherapy treatment for cervical cancer
- Pregnant or breastfeeding women
- Other cancers diagnosed within the last 5 years except non-melanoma skin cancer
- Inadequate kidney, liver, or blood function
- Cardiovascular disease classified as New York Heart Association class II or worse
- Existing peripheral neuropathy grade 2 or higher
AI-Screening
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Trial Site Locations
Total: 11 locations
1
CHU de Bordeaux
Bordeaux, France, 33000
Actively Recruiting
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Actively Recruiting
3
CHI Créteil
Créteil, France, 94000
Actively Recruiting
4
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
5
CH Lyon Sud
Pierre-Bénite, France, 69495
Actively Recruiting
6
CHU de Poitiers
Poitiers, France, 86000
Actively Recruiting
7
Institut de Cancérologie de l'Ouest - Nantes
Saint-Herblain, France, 44805
Actively Recruiting
8
CHU La Réunion
Saint-Pierre, France, 97448
Actively Recruiting
9
Clinique Pasteur
Toulouse, France, 31059
Actively Recruiting
10
University Hospital Toulouse
Toulouse, France
Actively Recruiting
11
CHU de Tours
Tours, France, 37044
Actively Recruiting
Research Team
S
Stéphanie MOTTON, MD
CONTACT
M
Mariavah RODRIGUEZ, CRA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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