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

NCT ID: NCT00085631

Last Updated: 2013-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2009-06-30

Brief Summary

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.

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.

Conditions

Cervical Cancer

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Given IV

hyperthermia treatment

Intervention Type: PROCEDURE

Patients undergo hyperthermia treatment over 60-90 minutes

brachytherapy

Intervention Type: RADIATION

Patients undergo brachytherapy for 2-3 days

external beam radiation therapy

Intervention Type: RADIATION

Patients undergo external beam radiation therapy once daily on days 1-5

Arm II

Patients received cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.

Group Type: ACTIVE_COMPARATOR

cisplatin

Intervention Type: DRUG

Given IV

brachytherapy

Intervention Type: RADIATION

Patients undergo brachytherapy for 2-3 days

external beam radiation therapy

Intervention Type: RADIATION

Patients undergo external beam radiation therapy once daily on days 1-5

Interventions

cisplatin

Given IV

Intervention Type: DRUG

hyperthermia treatment

Patients undergo hyperthermia treatment over 60-90 minutes

Intervention Type: PROCEDURE

brachytherapy

Patients undergo brachytherapy for 2-3 days

Intervention Type: RADIATION

external beam radiation therapy

Patients undergo external beam radiation therapy once daily on days 1-5

Intervention Type: RADIATION

Other Intervention Names

Platinol-AQ

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Mark Dewhirst

OTHER

Sponsor Role: lead

Responsible Party

Mark Dewhirst

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ellen L. Jones, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Cancer Institute

Leonard R. Prosnitz, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Cancer Institute

Mark Dewhirst, DVM PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Cancer Institute

Zeljko Vujaskovic, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Cancer Institute

Locations

Duke Cancer Institute

Durham, North Carolina, United States

Countries

Germany; Netherlands; Norway; United States

Other Identifiers

DUMC-4516

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000370860

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00005267

Identifier Type: -

Identifier Source: org_study_id