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
      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
  • 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
  • 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