Chemotherapy before standard treatment for cervical cancer spread to aortic lymph nodes
Tests carboplatin and paclitaxel before standard treatment in women with cervical cancer.
Key facts
- Who runs it
- University Hospital, Toulouse
- 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
- Registry title
- Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 310 people, planned
- Started
- 17 Jul 2020
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Carboplatin
- Paclitaxel
- Cisplatin
- Radiotherapy
- Record updated
- 21 September 2023
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with cervical cancer that has spread to the lymph nodes near the aorta, to compare extra chemotherapy before standard treatment with standard treatment alone.
- Age
- 18 years or older.
- Sex
- Women only.
- Disease stage
- Invasive cervical cancer (adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma), stage IB1 to IVA at diagnosis, with para-aortic lymph node involvement. Performance status ECOG 0-2.
- Earlier treatment
- No earlier chemotherapy for the cervical cancer.
- Biomarker or test result
- Para-aortic lymph nodes must be positive on a PET-CT scan, or proven by tissue examination if the PET-CT is negative. Kidney, liver and blood counts must be adequate (creatinine clearance ≥60 mL/min, platelets > 100x10 9/l, neutrophils > 1.5X10 9/l).
Main reasons for not taking part
- Stage IVB at diagnosis
- Other tumour types than adenocarcinoma, squamous cell or adenosquamous carcinoma
- Pregnant or breastfeeding
- Another cancer in the last 5 years (except non-melanoma skin cancer)
- Heart disease NYHA class II or more, or nerve damage grade 2 or more
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
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
About the trial
What the trial wants to find out
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
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.
The 2 groups in the trial
- Neoadjuvant chemotherapy+standard therapyTreatment being tested
neoadjuvant chemotherapy with carboplatin aera Under curve 5 and paclitaxel 175 mg/m² every 21 days during 3 cycles followed by standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
Treatment: Carboplatin, Paclitaxel, Cisplatin, and Radiotherapy
- standard therapy aloneExisting treatment, for comparison
standard therapy with extended field external radiotherapy and concomitant chemotherapy (Cisplatin 40mg/m2 weekly)
Treatment: Cisplatin and Radiotherapy
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- 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.
- Plain-language title
- Chemotherapy before standard treatment for cervical cancer spread to aortic lymph nodesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 September 2023