Cervical CancerNCT03249519
Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer
A study testing Radiation, brachytherapy and Cisplatin in people with Cervical Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome. 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?
- Radiation, brachytherapy and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 999 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to 31 Dec 2099
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Histological confirmed carcinoma of the Cervix
- FIGO-Stage IIB-IVA; earlier stages when inoperable or according to patient's wish
- clinical M0; except: involvement of para-aortic lymph nodes
- Age ≥ 18 years
- ECOG ≤ 2
- Informed consent of the patient
Who cannot join
- Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
- Cardiac Pacemaker
- Myocardial infarction within the past 12 months
- Congestive heart failure
- Complete bundle branch block
- New York Heart Association (NYHA) class III or IV heart disease
Show all 12Show fewer
- Disease that would preclude chemoradiation or deep regional hyperthermia
- Metal implants (length > 2cm or dense clusters of marker clips in the pelvis)
- Active or therapy-resistent bladder infections
- Pre-existing or concommitant immunodeficiency Syndrome
- Pregnant or lactating women
- Patients not willing to use effective contraception during and up to 6 months after therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, 91054
Oliver Ott, MD, ++49 9131 85 ext. 33968, st-studiensekretariat@uk-erlangen.de
About this study
Official title: Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome.
- Conditions
- Cervical Cancer
- Keywords
- Radiation therapy, Chemoradiation, Brachytherapy, Hyperthermia, Cervical cancer, Multimodality treatment of advanced cervical cancer
- Medical subject headings
- Uterine Cervical Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Also called Radiation therapy
50.4 Gy
brachytherapyRadiation
Also called Interstitial brachytherapy
35-40 Gy
CisplatinDrug
weekly 40 mg/m^2 (6cycles)
HyperthermiaOther
10 times
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | Experimental | Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times Receives: Radiation: Radiation; Radiation: brachytherapy; Drug: Cisplatin; Other: Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 years
Secondary outcomes (2)
Disease free survival (local / distant / overall)
Measured: 5 years
Safety by Toxicity assessment according to NCI CTCAE v4.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2094 (estimated)
- Study completion31 Dec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249519
- Sponsor's protocol ID
- HyZer_RCT_IBT
- Status last verified
- Aug 2017
- First submitted
- 10 Aug 2017
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia
- ClinicalTrials.gov ID
- NCT03249519
- Acronym / sponsor ID
- HyZer_RCT_IBT
- Conditions
- Cervical Cancer
- Keywords
- Radiation therapy, Chemoradiation, Brachytherapy, Hyperthermia, Cervical cancer, Multimodality treatment of advanced cervical cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2094 (estimated)
- Study completion
- 31 Dec 2099 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combination of radiation therapy or chemoradiation with Interstitial brachytherapy for advanced cervical cancer (pN+, FIGO-Stage II B - IV A is standard of therapy. The radio- and chemosensitive effect of an additional hyperthermia might improve the clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | Experimental | Radiation: Radiation, Radiation: brachytherapy, Drug: Cisplatin, Other: HyperthermiaRadiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m^2 (6 cycles) Hyperthermia: 10 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological confirmed carcinoma of the Cervix
- FIGO-Stage IIB-IVA; earlier stages when inoperable or according to patient's wish
- clinical M0; except: involvement of para-aortic lymph nodes
- Age ≥ 18 years
- ECOG ≤ 2
Key exclusion criteria (12 listed)
- Pre-existing uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy
- Cardiac Pacemaker
- Myocardial infarction within the past 12 months
- Congestive heart failure
- Complete bundle branch block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationAlso: Radiation therapy50.4 Gy | Radiation | Standard Arm |
| brachytherapyAlso: Interstitial brachytherapy35-40 Gy | Radiation | Standard Arm |
| Cisplatinweekly 40 mg/m^2 (6cycles) | Drug | Standard Arm |
| Hyperthermia10 times | Other | Standard Arm |
Primary outcome
Overall survival
Time frame: 5 years
2 secondary outcomes
Disease free survival (local / distant / overall)
Time frame: 5 years
Safety by Toxicity assessment according to NCI CTCAE v4.0
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation, brachytherapy and Cisplatin in people with Cervical Cancer, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 12 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: looking for participants now, as of the sponsor's last update on 15 Aug 2017. 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 Germany. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver Ott, MD (++49 9131 85 ext. 33968, st-studiensekretariat@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2017.