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