Groupe d'Etude en Oncologie du Quebec

Titre	Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy
Protocole ID	RTOG 0724
ClinicalTrials.gov ID	NCT00980954
Type(s) de cancer	Col
Phase	Phase III
Institution	CENTRE UNIVERSITAIRE DE SANTE MCGILL SITE GLEN 1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville	Montréal
Investigateur(trice) principal(e)	Dr Luis Souhami
Coordonnateur(trice)	Ginette Ricard 514-934-1934 poste 43186
Statut	Actif en recrutement
Critètes d'éligibilité	DISEASE CHARACTERISTICS: Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery: Positive pelvic nodes Positive parametrium Positive para-aortic nodes that have been completely resected and are PET/CT scan-negative Clinical stage IA2, IB, or IIA disease (this corresponds to surgical TNM staging of T1-T2, N1, M0) Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days Para-aortic and pelvic node sampling required No gross residual disease No neuroendocrine histology No distant metastases PATIENT CHARACTERISTICS: Zubrod performance status 0-1 ANC ≥ 1,800/mm³ Platelets ≥ 100,000/mm³ WBC ≥ 4,000/mm³ Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed) Serum creatinine ≤ 1.5 mg/dL Bilirubin ≤ 1.5 times upper limit of normal ALT and/or AST normal Alkaline phosphatase normal Known HIV positivity allowed provided CD4 count is ≥ 350/mm³ within the past 14 days No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix No severe, active co-morbidity, including any of the following: Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months Transmural myocardial infarction within the past 6 months Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry Coagulation defects No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior systemic chemotherapy for the current cervical cancer Prior chemotherapy for a different cancer is allowed No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields
Critètes d'exclusion

Groupe d'étude en oncologie du Québec