NCT03249519

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for not_applicable

Timeline
896mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Aug 2017Dec 2099

Study Start

First participant enrolled

August 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2017

Completed
77.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2094

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2099

Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

77.5 years

First QC Date

August 10, 2017

Last Update Submit

August 10, 2017

Conditions

Cervical Cancer

Keywords

Radiation therapyChemoradiationBrachytherapyHyperthermiaCervical cancerMultimodality treatment of advanced cervical cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    5 years

Secondary Outcomes (2)

  • Disease free survival (local / distant / overall)

    5 years

  • Safety by Toxicity assessment according to NCI CTCAE v4.0

    5 years

Study Arms (1)

Standard Arm

EXPERIMENTAL

Radiation therapy: 50.4 Gy Brachytherapy: 35-40 Gy Chemotherapy: Cisplatin weekly 40mg/m\^2 (6 cycles) Hyperthermia: 10 times

Radiation: RadiationRadiation: brachytherapyDrug: CisplatinOther: Hyperthermia

Interventions

RadiationRADIATION

50.4 Gy

Also known as: Radiation therapy
Standard Arm
brachytherapyRADIATION

35-40 Gy

Also known as: Interstitial brachytherapy
Standard Arm
CisplatinDRUG

weekly 40 mg/m\^2 (6cycles)

Standard Arm
HyperthermiaOTHER

10 times

Standard Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsHyperthermia

Interventions

RadiationRadiotherapyBrachytherapyCisplatinDiathermy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical PhenomenaTherapeuticsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHyperthermia, Induced

Central Study Contacts

Oliver Ott, MD

CONTACT

++49 9131 85st-studiensekretariat@uk-erlangen.de

Rainer Fietkau, MD

CONTACT

++49 9131 85st-studiensekretariat@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 15, 2017

Study Start

August 1, 2017

Primary Completion (Estimated)

December 31, 2094

Study Completion (Estimated)

December 31, 2099

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

DE(1)