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

NCT00085631 | Terminated Phase 3 Results

• 3 other identifiers: Pro00005267DUMC-4516CDR0000370860
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Primary Tumor Response Rate at 4-6 Weeks Post Treatment

  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.

  3 months from start of therapy

• Five-year Failure-free Survival

  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.

  5 Years

• Five-Year Local Recurrence-Free Survival

  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.

  5 years

• Five-Year Overall Survival

  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.

  5 Years

Study Arms (2)

Arm I

EXPERIMENTAL

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; Procedure: hyperthermia treatment; Radiation: brachytherapy; Radiation: external beam radiation therapy

Arm II

ACTIVE COMPARATOR

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

Drug: cisplatin; Radiation: brachytherapy; Radiation: external beam radiation therapy

Interventions

cisplatin DRUG

Given IV

Also known as: Platinol-AQ

Arm I; Arm II

hyperthermia treatment PROCEDURE

Patients undergo hyperthermia treatment over 60-90 minutes

Arm I

brachytherapy RADIATION

Patients undergo brachytherapy for 2-3 days

Arm I; Arm II

external beam radiation therapy RADIATION

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

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mark Dewhirst: lead
• National Cancer Institute (NCI): collaborator
• Northwestern University: collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Cisplatin; Diathermy; Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Hyperthermia, Induced; Therapeutics; Radiotherapy

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr Mark Dewhirst
• Organization: Duke University Medical Center

joan.cahill@dm.duke.edu

919 6683726

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: June 1, 2009
• Last Updated: September 17, 2013
• Results First Posted: September 17, 2013

Record last verified: 2013-07

Locations

US (1)