Chemotherapy before standard treatment for cervical cancer spread to aortic lymph nodes
Tests carboplatin and paclitaxel before standard treatment in women with cervical cancer.
Plain-language title generated from the registry record
Registry title: Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
Key facts
- Where
- Bordeaux, Clermont Ferrand Cedex 1, Creteil, Lille, Marseille, Paris, Pierre-Bénite, Poitiers, Saint-Denis, Saint-Herblain Cedex, Toulouse, Toulouse Cedex 3, and Tours Cedex 9, FranceSee the 13 sites
- Phase
- Phase 3
Where in France
- Centre hospitalier Universitaire de BordeauxBordeaux, FranceNo longer taking part
- University Hospital Of Clermont-FerrandClermont Ferrand Cedex 1, FranceNo longer taking part
- Sodexo Shop ExperienceCreteil, FranceNo longer taking part
- Centre Oscar LambretLille, FranceNo longer taking part
- Institut Paoli-CalmettesMarseille, FranceNo longer taking part
- Assistance Publique Hopitaux de ParisParis, FranceNo longer taking part
- Hospices Civils de LyonPierre-Bénite, FranceNo longer taking part
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceNo longer taking part
- Centre Hospitalier Universitaire De La ReunionSaint-Denis, FranceNo longer taking part
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranceNo longer taking part
- Centre Hospitalier Universitaire de ToulouseToulouse, FranceNo longer taking part
- Clinique PasteurToulouse Cedex 3, FranceNo longer taking part
- Centre Hospitalier Regional Universitaire De ToursTours Cedex 9, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Toulouse
- Trial code
- NCT03534713EU 2024-513576-18-00
- Record updated
- 21 September 2023
- Original description
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.Read full original descriptionShow less
Phase III Study Comparing Neoadjuvant Chemotherapy With Carboplatin and Paclitaxel Followed by Standard Therapy, With Standard Therapy Alone in Women With Cervical Cancer and Para Aortic Positive Lymph Node.
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.
Inclusion: Women with histologically proven invasive carcinoma of the uterine cervix and para aortic lymphadenopathy determined by either a positive positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography or if negative positron emission tomography computed tomography based on histological examination of paraaortic lymph node dissection; Performance status Eastern Cooperative Oncology Group 0-2; Stage International Federation of Gynecology and Obstetrics IB1 to IVA at diagnosis with para-aortic lymph node involvement; Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma; Adequate renal function (creatinine clearance ≥60 mL/min); Adequate hepatic function (bilirubin <1.5 times normal and Serum Glutamooxaloacetate Transferase < 3 times normal); Adequate hematopoietic function Platelet count > 100x10 9/l and Absolute neutrophil count > 1.5X10 9/l); Written Informed consent for participation.
Exclusion: Women who receive any prior chemotherapy for her cervical cancer; Prior ( within the last 5 years) malignancies other than non-melanoma skin cancer; Inadequate renal, hepatic or hematopoietic function (Cf previously); Cardiovascular pathology New York Heart Association II or more; Stage Federation of Gynecology and Obstetrics IVB at diagnosis; Others histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma; Pregnant or lactating women; Pre-existing Peripheral neuropathy Common toxicity Criteria grade ≥ 2.