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NCT Number: NCT03249519

Radiation Therapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia in Advanced Cervical Cancer

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.

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Key information

Conditions

Cervical Cancer Body Temperature Changes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Heat Stress Disorders Hyperthermia Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Erlangen, Strahlenklinik

Erlangen, 91054, Germany

Location status: Recruiting

Location contact

Oliver Ott, MD

CONTACT

[email protected]

++49 9131 85 ext. 33968

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Radiation

Radiation

50.4 Gy

Other names: Radiation therapy

Brachytherapy

Radiation

35-40 Gy

Other names: Interstitial brachytherapy

Cisplatin

Drug

weekly 40 mg/m^2 (6cycles)

Hyperthermia

Other

10 times

Primary outcomes

  1. Overall survival

    Time frame: 5 years

Secondary outcomes

  1. Disease free survival (local / distant / overall)

    Time frame: 5 years

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

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Oliver Ott, MD

CONTACT

[email protected]

++49 9131 85 ext. 33968

Rainer Fietkau, MD

CONTACT

[email protected]

++49 9131 85 ext. 33968

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

Multimodal Therapy of Advanced Cervical Cancer With Radiotherapy or Chemoradiation, Interstitial Brachytherapy in Combination With Hyperthermia

Important dates

Study start
2017
Primary completion
2094
Study completion
2099
First posted
Aug 15, 2017
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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