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Cervical CancerPhase 3NCT00085631

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

A Phase 3 study testing cisplatin, hyperthermia treatment and brachytherapy in people with Cervical Cancer, run by Mark Dewhirst at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
cisplatin, hyperthermia treatment and brachytherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteUnited States
Study dates
Mar 2003to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Cancer Institute

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: An International Multi Center Phase III Study of Chemoradiotherapy Versus Chemoradiotherapy Plus Hyperthermia for Locally Advanced Cervical Cancer

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.

Read the 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
Being tested
cisplatin, hyperthermia treatment, brachytherapy, external beam radiation therapy
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
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatinDrug

    Also called Platinol-AQ

    Given IV

  • hyperthermia treatmentProcedure or surgery

    Patients undergo hyperthermia treatment over 60-90 minutes

  • brachytherapyRadiation

    Patients undergo brachytherapy for 2-3 days

  • external beam radiation therapyRadiation

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

Study groups in NCT00085631
Study groupRoleWhat they receive
Arm IExperimentalPatients 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.
Receives: Drug: cisplatin; Procedure: hyperthermia treatment; Radiation: brachytherapy; Radiation: external beam radiation therapy
Arm IIActive comparatorPatients received cisplatin and undergo external beam radiation therapy (and brachytherapy) as in arm I.
Receives: Drug: cisplatin; Radiation: brachytherapy; Radiation: external beam radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months from start of therapy

  2. 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.

    Measured: 5 Years

  3. 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.

    Measured: 5 years

  4. 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.

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2004 (estimated)
  2. Study startMar 2003
  3. Primary completionNov 2008
  4. Study completionJun 2009

Why it stopped: Study was closed because of slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085631
Sponsor's protocol ID
Pro00005267
Other IDs
DUMC-4516, CDR0000370860
Status last verified
Jul 2013
First submitted
10 Jun 2004
Last updated
17 Sep 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, hyperthermia treatment and brachytherapy in people with Cervical Cancer, run by Mark Dewhirst at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Tumor Response Rate at 4-6 Weeks Post Treatment (time frame: 3 months from start of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00085631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.

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