Cisplatin and Radiation Therapy With or Without Carboplatin and Paclitaxel in Patients With Locally Advanced Cervical Cancer

Completed · Phase 3

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT01414608

Run by

GOG Foundation

People needed

926

Starts

2012-01-09

Expected to finish

2021-07-09

Last updated by the study team

2022-11-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Arizona Oncology Associates-Biltmore Cancer Center — Phoenix, Arizona, United States
• Arizona Oncology Associates-West Orange Grove — Tucson, Arizona, United States
• Arizona Oncology Associates-Wilmot — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• John Muir Medical Center-Concord Campus — Concord, California, United States
• Sutter Davis Hospital — Davis, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Memorial Medical Center — Modesto, California, United States
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States
• Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Saint Joseph Hospital - Orange — Orange, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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