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Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma (HT01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03428867
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Daniel Zips, University Hospital Tuebingen

Study Description
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Brief Summary:
goal of this study is to check the effecivity, feasibility and toxicity of the chemoradiotherapy and hyperthermia

Condition or disease
Feasibilitystudy

Detailed Description:

Radiation: 5x1,8Gy until 50,4 Gy Hyperthermia: 2x/week

Chemotherapy:

neoadjuvant= day 1-5 and day 29-33 5FU 1000mg/m2 adjuvant = 4 Cycles 5FU 500mg/m2 all 4 weeks

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Phase II Studie Zur Neoadjuvanten Trimodalen Hyperthermen Radiochemotherapie Des Tief Sitzenden Rektumskarzinoms im Stadium UICC II + III
Study Start Date : August 2012
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 31, 2017
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. remission [ Time Frame: 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with rectumcarcinoma stage UICC II+III
Criteria

Inclusion Criteria:

adenocarcinoma until 10 cm until ano UICC II+III 18-80 years old ECOG PS 0-2 Informed Consent

Exclusion Criteria:

cardiac insufficiency last 6 month heartattack nodal AV pressure III° hip prothesis cardiac pacemaker others contraindikations against the therapie radiation of pelvis chronic gestrointestinal desaese gestation or lactation previous radiotion pelvis previous Chemotherapie second carcinoma beside baslioma infiltation in analarea

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428867


Locations
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Germany
University Hospital Tuebingen
Tuebingen, Baden Württemberg, Germany, 72070
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Daniel Zips, Prof.Dr. University Hospital Tuebingen
More Information
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Additional Information:

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Responsible Party: Prof. Dr. med. Daniel Zips, Prof.Dr. med., University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT03428867    
Other Study ID Numbers: UKT_RO_HT_01
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018