Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer
Condition: Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma, Not Otherwise Specified; Stage IB Cervical Cancer AJCC v6 and v7; Stage IIA Cervical Cancer AJCC v7; Stage IIB Cervical Cancer AJCC v6 and v7; Stage IIIB Cervical Cancer AJCC v6 and v7; Stage IVA Cervical Cancer AJCC v6 and v7
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Uterine Cervical Neoplasms; Carcinoma, Adenosquamous
Intervention: Brachytherapy; Carboplatin; Cisplatin; External Beam Radiation Therapy; Paclitaxel; Quality-of-Life Assessment
Intervention description: Undergo brachytherapy; Given IV; Given IV; Undergo external beam radiation therapy; Given IV; Ancillary studies
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Albumin-Bound Paclitaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 926.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well giving cisplatin and radiation therapy
      together with or without carboplatin and paclitaxel works in treating patients with cervical
      cancer has spread from where it started to nearby tissue or lymph nodes. Drugs used in
      chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop
      the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from
      dividing, or by stopping them from spreading. External radiation therapy uses high-energy x
      rays to kill tumor cells. Internal radiation uses radioactive material placed directly into
      or near a tumor to kill tumor cells. It is not yet known whether giving cisplatin and
      external and internal radiation therapy together with carboplatin and paclitaxel kills more
      tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible patients will have locally advanced cervical cancer suitable for primary
             treatment with chemoradiation with curative intent, in addition to:

               -  Federation of Gynecology and Obstetrics (FIGO) 2008 stage IB1 & node positive,
                  IB2, IIA, IIB, IIIB, or IVA disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous
             cell carcinoma of the cervix

          -  White blood cells (WBC) >= 3.0 x 10^9/L

          -  Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

          -  Platelet count >= 100 x 10^9/L

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x ULN (if
             both tests are done, both results need to be =< 2.5 x ULN)

          -  Creatinine =< ULN (Common Toxicity Criteria [CTC] grade 0) OR calculated creatinine
             clearance (Cockcroft-Gault formula) >= 60 mL/min OR >= 50 mL/min by
             ethylenediaminetetraacetic acid (EDTA) creatinine clearance

          -  Written informed consent

        Exclusion Criteria:

          -  Any previous pelvic radiotherapy

          -  Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if
             biopsy proven, PET positive, or >= 15 mm short-axis diameter on computed tomography
             [CT])

          -  FIGO 2008 stage IIIA disease

          -  Patients assessed at presentation as requiring interstitial brachytherapy treatment

          -  Patients with bilateral hydronephrosis unless at least one side has been stented and
             renal function fulfills the required inclusion criteria

          -  Previous chemotherapy for this tumor

          -  Evidence of distant metastases

          -  Prior diagnosis of Crohn's disease or ulcerative colitis

          -  Peripheral neuropathy >= grade 2 (per Common Terminology Criteria for Adverse Events
             [CTCAE] version [v]4)

          -  Patients who have undergone a previous hysterectomy or will have a hysterectomy as
             part of their initial cervical cancer therapy; this includes patients with a prior
             history of supracervical hysterectomy

          -  Patients with other invasive malignancies, with the exception of non-melanoma skin
             cancer and in situ melanoma, who had (or have) any evidence of the other cancer
             present within the last 5 years

          -  Patients who are pregnant or lactating

          -  Any contraindication to the use of cisplatin, carboplatin, or paclitaxel chemotherapy

          -  Serious illness or medical condition that precludes the safe administration of the
             trial treatment including, but not limited to, ongoing or active infection,
             symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or
             psychiatric illness/social situations that would limit compliance with study
             requirements

          -  Patients who are known to be human immunodeficiency virus (HIV) positive