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AzTrials

Cervical CancerPhase 2NCT00008112

Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II, Stage III, or Stage IV Cervical Cancer

A Phase 2 study testing cisplatin, hyperthermia treatment and brachytherapy in people with Cervical Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use 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
Type of treatment
Surgery or procedure
How many people
Not given
Where
4 sitesNetherlands
Study dates
Jun 2000to not given
Phase
Phase 2
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IIB-IVA carcinoma of the cervix
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Mixed cell histology
  • No small cell anaplastic histology
  • No para-aortic lymph node involvement
  • No indication for para-aortic radiotherapy
  • No distant metastases
  • No CNS disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 7.0 mmol/L (approximately 11 g/dL)
  • Epoetin alfa and/or transfusion allowed

Hepatic:

  • Not specified

Renal:

  • Glomerular filtration rate at least 60 mL/min

Cardiovascular:

  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No congestive heart failure with expected inability to tolerate fluid load
  • No cerebrovascular accident within the past 6 months

Other:

  • No pacemaker and/or metal implants
  • No active uncontrolled infection
  • No compromised immune status
  • No psychosis
  • No other prior malignancy except nonmelanoma skin cancer
  • No mental or other physical inability that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy

Surgery:

  • No prior surgery

Trial locations and contacts

4 sites in 1 country.

Netherlands4 sites

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • University Hospital - Rotterdam Dijkzigt

    Rotterdam, 3000 CA

  • Rotterdam Cancer Institute

    Rotterdam, 3075 EA

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Feasibility Study of the Combination of Radiotherapy, Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer

RATIONALE: Drugs used in chemotherapy use 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. Combining hyperthermia with radiation therapy and chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin combined with radiation therapy and hyperthermia in treating patients who have stage II, stage III, or stage IV cervical cancer.

Read the detailed description

OBJECTIVES:

  • Determine the feasibility of adding cisplatin and locoregional hyperthermia to external beam and intracavity radiotherapy in patients with stage IIB-IVA cervical cancer.
  • Determine the acute toxicity of this regimen in these patients.
  • Determine the complete response rate of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo external beam radiotherapy (EBRT) once daily 5 days a week for 5 weeks. On 1 day of each week, patients also receive cisplatin IV over 3 hours and hyperthermia over 90 minutes beginning 1-6 hours after completion of EBRT. During week 6, patients receive hyperthermia and cisplatin on the day before the 1 day of intracavity radiotherapy. Treatment continues in the absence of unacceptable toxicity.

Patients are followed at 6-8 weeks, every 3 months for 3 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 6-34 patients will be accrued for this study.

Conditions
Cervical Cancer
Being tested
cisplatin, hyperthermia treatment, brachytherapy, radiation therapy
Keywords
stage III cervical cancer, stage IIB cervical cancer, stage IVA cervical cancer, cervical squamous cell carcinoma, cervical adenocarcinoma, cervical adenosquamous 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

  • hyperthermia treatmentProcedure or surgery

  • brachytherapyRadiation

  • radiation therapyRadiation

Timeline

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

  1. First posted5 Jun 2003 (estimated)
  2. Study startJun 2000

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 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00008112
Sponsor's protocol ID
DUT-KWF-CKVO-2000-02
Other IDs
CDR0000068376, EU-20036
Status last verified
Oct 2002
First submitted
6 Jan 2001
Last updated
7 Aug 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin, hyperthermia treatment and brachytherapy in people with Cervical Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 4 sites in Netherlands.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00008112.

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 7 Aug 2013.

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