Cisplatin and Radiation Therapy With or Without Hyperthermia Therapy in Treating Patients With Cervical Cancer

This study has been terminated.
(Study was closed because of slow accrual)
Sponsor:
Collaborators:
Northwestern University
Information provided by (Responsible Party):
Mark Dewhirst, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00085631
First received: June 10, 2004
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. It is not yet known whether chemotherapy and radiation therapy are more effective with or without hyperthermia therapy in treating cervical cancer.

PURPOSE: This randomized phase III trial compared the safety and efficacy of cisplatin and radiation therapy, together with hyperthermia therapy versus cisplatin and radiation therapy alone in the treatment of locally advanced cervical cancer.


Condition Intervention Phase
Cervical Cancer
Drug: cisplatin
Procedure: hyperthermia treatment
Radiation: brachytherapy
Radiation: external beam radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Primary Tumor Response Rate at 4-6 Weeks Post Treatment [ Time Frame: 3 months from start of therapy ] [ Designated as safety issue: No ]
    Primary tumor response rate is the proportion of subjects achieving a best response of complete (CR) or partial (PR) responses, according to the RECIST criteria for change in sum of longest diameters.

  • Five-year Failure-free Survival [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Five-year failure free survival (FFS) time was defined as the time from randomization until relapse/disease progression (local and/or distant) or death from any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year FFS rate is a percentage representing the fraction of randomized patients who, after 5 years, are disease free or alive.

  • Five-Year Local Recurrence-Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Five-year local recurrence-free survival (LRFS) time was defined as the time from randomization until local progressive disease or death from any cause. Local recurrence was defined as evidence of disease progression on physical exam or radiologic study, confirmed histologically by tissue biopsy. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The 5-year LRFS rate is a percentage representing the fraction of randomized patients who, after 5 years, do not have local progression or are alive.

  • Five-Year Overall Survival [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Five-year overall survival (OS) time was time from date of randomization until death from any cause. The 5-year OS rate is a percentage, representing the fraction of randomized patients who, after 5 years, are still alive.


Enrollment: 101
Study Start Date: March 2003
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients received cisplatin IV and concurrently underwent hyperthermia treatment over 60-90 minutes on day 1. Patients also underwent external beam radiation therapy once daily on days 1-5. Treatment repeated weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity. After completion of chemoradiotherapy and hyperthermia, patients underwent brachytherapy to the cervix for 2-3 days.
Drug: cisplatin
Given IV
Other Name: Platinol-AQ
Procedure: hyperthermia treatment
Patients undergo hyperthermia treatment over 60-90 minutes
Radiation: brachytherapy
Patients undergo brachytherapy for 2-3 days
Radiation: external beam radiation therapy
Patients undergo external beam radiation therapy once daily on days 1-5
Active Comparator: Arm II
Patients received cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.
Drug: cisplatin
Given IV
Other Name: Platinol-AQ
Radiation: brachytherapy
Patients undergo brachytherapy for 2-3 days
Radiation: external beam radiation therapy
Patients undergo external beam radiation therapy once daily on days 1-5

Detailed Description:

OBJECTIVES:

Compare local control, failure-free survival, and overall survival of patients with locally advanced carcinoma of the cervix treated with cisplatin and radiotherapy alone, versus cisplatin and radiotherapy with hyperthermia .

OUTLINE:

This is a randomized, multicenter study. Patients are stratified according to participating center, disease stage (IIB or IIIA vs IIIB or IVA) and age (< 60 years vs ≥ 60 years). Patients are randomized to 1 of 2 treatment arms.

LIMITATIONS:

There are integrity issues with the currently available data, involving international institutions, in that several pieces of information relating to patient accrual and outcomes cannot be verified. Therefore, it would be inappropriate to report outcome measures for this study. Baseline measures of age and gender are reported for the entire study cohort. Participant flow is reported by treatment arm assignment, which was available for a majority of patients in the currently available data. Adverse events are reported for the entire cohort, as some adverse events could not be classified within a particular treatment arm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Invasive cervical carcinoma (squamous, adeno or adenosquamous histologies, small cell histology excluded)

  • age >18years
  • International Federation of Gynecology and Obstetrics ((FIGO) stage IB2, IIA-IVA, FIGO stages IA, IB1 with positive pelvic lymph nodes or parametria either on imaging techniques or pathologically involved at the time of surgery.

patients undergoing surgical removal of the cervix and uterus are not eligible, parametria either on imaging techniques or pathologically involved at the time • Performance status Eastern Cooperative Oncology Group(ECOG)/World Health Organisation (WHO) 0, 1 or >/=70%respectively White Blood count (WBC) ≥ 3,000, platelets ≥ 100,000, Absolute Neutrophil Count (ANC) > 1500

• serum bilirubin ≤ 1.5 times upper limit of normal, transaminase ≤ 3 times upper limit of normal calculated creatinine clearance >60milliliters (mls)/liter ( Cockcroft) OR creatinine </= 2.0mgs% paraaortic adenopathy absent or 1.5 centimeter (cm) in greatest dimension on Computerised Tomography (CT) or Magnetic Resonance Imaging (MRI) scan;

No history of myocardial infarction in the last 6 months no symptomatic angina pectoris negative pregnancy test in patients under 50 Hemoglobin >12.0 Gd/dl or >7.5 mmo;/L with transfusion if needed written written informed consent

Exclusion criteria:

surgical resection of the primary tumor (i.e. Total abdominal hysterectomy (TAH)/ Bilateral salpingoophorectomy (BSO)

  • patients with pacemakers or implanted defibrillators
  • patients with significant metallic foreign bodies (i.e. hip replacements, bone metallic rods,orthopedic plates, etc.)
  • prior radiotherapy or chemotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085631

Locations
United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Mark Dewhirst
Northwestern University
Investigators
Principal Investigator: Ellen L. Jones, MD, PhD Duke Cancer Institute
Principal Investigator: Leonard R. Prosnitz, MD Duke Cancer Institute
Principal Investigator: Mark Dewhirst, DVM PhD Duke Cancer Institute
Principal Investigator: Zeljko Vujaskovic, MD PhD Duke Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Mark Dewhirst, Professor, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00085631     History of Changes
Other Study ID Numbers: Pro00005267, DUMC-4516, CDR0000370860
Study First Received: June 10, 2004
Results First Received: April 10, 2013
Last Updated: July 10, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Duke University:
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer
stage III cervical cancer
stage IVA cervical cancer
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Fever
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Body Temperature Changes
Signs and Symptoms
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014