NCT03534713RecruitingPhase 3
Induction Chemotherapy Followed by Standard Therapy in Cervical Cancer With Aortic Lymph Node Spread
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.
Source: ClinicalTrials.gov · Last updated 21 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 310 (estimated)
- First submitted
- 16 Apr 2018
- Start date
- 17 Jul 2020
- Primary completion date
- Sept 2026
- Lead sponsor
- University Hospital, Toulouse
- Diseases
- Cervical cancer
- NCT number
- NCT03534713
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 310
- From 17 Jul 2020 to the primary completion date, Sept 2026
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Cardiovascular pathology New York Heart Association II or more
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Chi Creteil Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| CH Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| CHU de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Institut de Cancérologie de l'Ouest - Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| CHU La Réunion Coordinator of this site? Confirm its status | Saint-Pierre | France | Recruiting |
| University Hospital, Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| CHU de Tours Coordinator of this site? Confirm its status | Tours | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.