A Phase II Study of Extended Field IMRT External Beam Irradiation and Intracavitary Brachytherapy
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: IMRT extended field external beam radiation therapy; Brachytherapy; Cisplatin
Intervention MeSH terms: Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: para-aortic lymph nodes

Summary:

      Recent studies have shown that the chance of survival among women with advanced cervical
      cancer is increased when they receive concurrent chemotherapy and radiation to the pelvis.
      However, patients who have advanced disease show loco-regional failure as well as a high
      incidence of distant metastasis. Positron emission tomography (PET) scanning has high
      sensitivity and specificity in the detection of pelvic and para-aortic lymph node metastases.
      While the detection of para-aortic metastases by PET significantly impacts prognosis, PET has
      been known to show positive lymph node metastasis in the pelvis only while not detecting
      micrometastatic disease in the para-aortic lymph nodes (despite the fact that they are
      histologically known).

      In addition, patients with positive para-aortic lymph nodes on PET, greater amounts (more
      than 45 Gy) of radiation must be used to improve the probability of controlling the cancer.
      However, doses greater than this have been limited because of the dose and volume limits to
      the small bowel. But, Intensity Modulated Radiation Therapy (IMRT) is a new way of
      calculating and delivering radiation therapy. Compared to external beam radiation, IMRT has
      the improved ability to deliver large doses of radiation to specific targets while minimizing
      the exposure to surrounding normal tissue.

      With IMRT, however, the effective dose/volume can be increased more safely and lower the
      toxicity of surrounding tissue, thus making prophylactic dosing to para-aortic lymph nodes
      not detected by PET safer and more effective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have carcinoma of the uterine cervix.

          -  Patients with squamous cell, adenocarcinoma, and adenosquamous carcinoma are eligible.

          -  International Federation of Gynecology and Obstetrics (FIGO) Stage I to IVA

          -  Patients must have no evidence of metastatic disease outside of the pelvis (except to
             the para-aortic nodes), by PET.

          -  Patients must have a Karnofsky Performance Status of >= 60 and no medical
             contraindications to the administration of chemotherapy.

          -  Age >= 18.

          -  Adequate bone marrow function: white blood cells (WBC) >= 4000/mm3, platelets >=
             100,000 mm3.

          -  Adequate renal function: BUN <= 25 mg/dl, creatinine <= 1.2 mg/dl (urinary diversion
             is permitted to improve renal function).

          -  Patients must have bilirubin <= 1.5 mg/dl.

          -  Signed study-specific informed consent.

        Exclusion Criteria:

          -  No positive lymph nodes by FDG PET

          -  Positive supraclavicular lymph nodes by FDG PET Scan or evidence of more distant
             disease.

          -  FIGO Stage IVB+ Cervical Cancer

          -  No prior (within 5 years) or simultaneous malignancies (other than cutaneous basal
             cell carcinoma).

          -  Karnofsky Performance Status <60.

          -  Patients with significant medical illness preventing the use of full dose chemotherapy
             are excluded.

          -  Patients with the following histologies are excluded: small cell, carcinoid, glassy
             cell, clear cell and adenoid cystic.

          -  Life expectancy < 6 months.

          -  Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200
             mg/dL) are not eligible.

          -  No prior surgery for treatment of disease other than exploratory laparotomy or biopsy.

          -  No previous systemic chemotherapy.

          -  No pelvic radiation therapy is permitted other than transvaginal irradiation to
             control bleeding.

          -  Pregnant women are ineligible and those of child-bearing potential should practice
             contraception.

          -  Patients with abnormal liver function tests