CTIS2024-513576-18-00
Active, not recruiting
Phase 1
Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-01 - RC31/17-0213
ConditionsCervical CancerMedDRA version: 21.1Level: LLTClassification code: 10008229Term: Cervical cancer Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10008236Term: Cervical cancer stage IV Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10008235Term: Cervical cancer stage III Class: 10029104Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]Therapeutic area: Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Centre Hospitalier Universitaire De Toulouse
- Enrollment
- 310
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient with cervical cancer WITH para\-aortic lymph node involvement determined by either a positive 18F\-FDG PET\-CT (visual interpretation of metabolic activity of para\-aortic lymph node, greater than the background noise), or by histological examination of para\-aortic lymph nodes if negative 18F\-FDG PET\-CT, Signed written informed consent, Affiliated to a social security insurance or equivalent, Age \=18 years, ECOG performance status of 0 to 2, FIGO stage IIIC2 or IVA WITH para\-aortic lymph node involvement at the time of diagnosis, Adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma, Normal renal function (creatinine clearance \=60 mL/min), Normal liver function (total bilirubin \<1\.5 times the upper limit of normal (ULN) and AST \<3 ULN), Normal haematological assessment (platelets \>100×109/L and neutrophils \>1\.5×109/L), Women of childbearing potential and not postmenopausal must have a negative blood serum or urine pregnancy test before starting the study treatment
Exclusion Criteria
- •Patients who have received prior chemotherapy or radiotherapy for their cervical cancer, Pregnant or breastfeeding women, History of invasive cancer (in the last five years) other than non\-melanoma skin cancer, Acute, uncontrolled cardiovascular disease, Peripheral neuropathy of CTCAE grade 3\-4, Known hypersensitivity to Paclitaxel, Cisplatin or other platinum\-containing compounds, Patients under legal protection
Outcomes
Primary Outcomes
Not specified
Similar Trials
Suspended
Phase 3
Induction chemotherapy followed by standard concurrent chemoradiotherapy in cervical cancer with para-aortic lymph node involvement: A phase III, multicenter, parallel-group randomized, controlled trial - ONCOCOL-012024-513576-18-00Centre Hospitalier Universitaire De Toulouse310
Active, not recruiting
Not Applicable
Induction chemotherapy followed by chemoradiation with cetuximab and cisplatin for inoperable squamous cell carcinoma of the head and neck.Inoperable squamous cell carcinoma of the head and neck.EUCTR2006-003381-33-SIInstitute of Oncology Ljubljana
Not yet recruiting
Not Applicable
Induction chemotherapy followed by chemoradiation in loco-regionally advanced nasopharyngeal carcinomaHealth Condition 1: C119- Malignant neoplasm of nasopharynx,unspecifiedCTRI/2022/08/044617Jawaharlal Institute of Postgraduate Medical Education and Research
Active, not recruiting
Not Applicable
Phase I/II study on induction chemotherapy followed by chemoradiation with or without lapatinib, a dual EGFR/ErbB2 kinase inhibitor, in patients with locally advanced resectable larynx and hypopharynx squamous cell carcinomaEUCTR2006-002667-33-BEEuropean Organisation for Research and Treatment of Cancer
Recruiting
Not Applicable
A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancerPancreatic cancerJPRN-UMIN000034410Keio University School of Medicine40