test

A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: The Outback Trial

Conditions

Trial Phase

Phase III

Trial Purpose and Description

Trial Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, carboplatin, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 know whether giving cisplatin and external and internal radiation therapy together with carboplatin and paclitaxel kill more tumor cells.

PURPOSE: 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 locally advanced cervical cancer.


Participation Guidelines

Age:
Gender:
Female

Eligibility Criteria

Criteria

DISEASE CHARACTERISTICS:

  • Eligible patients will have locally advanced cervical cancer suitable for primary treatment with chemoradiation with curative intent, in addition to:

    • Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix
    • FIGO 2008 stage IB1 & node positive, IB2, II, IIIB, or IVA disease
  • No patients assessed at presentation as requiring interstitial brachytherapy treatment
  • No para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven, PET positive, or &ge 15 mm short-axis diameter on CT)
  • No evidence of distant metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • WBC &ge 3,000/mm³
  • ANC &ge 1,500/mm³
  • Platelet count &ge 100,000/mm³
  • Bilirubin &le 1.5 times upper limit of normal (ULN)
  • AST/ALT &le 2.5 times ULN
  • Creatinine &le ULN (CTC Grade 0) OR calculated creatinine clearance &ge 60 mL/min OR &ge 50 mL/min by EDTA creatinine clearance
  • No patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria
  • No prior diagnosis of Crohn disease or ulcerative colitis
  • No peripheral neuropathy &ge grade 2 (per CTCAE v. 4)
  • No 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
  • No patients who are pregnant or lactating
  • No 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
  • Not HIV positive
Sponsor:
Gynecologic Oncology Group
Dates:
07/15/2013
Last Updated:
Study HIC#:
1304011910