Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma

NCT ID: NCT03428867

Last Updated: 2018-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-07-31

Brief Summary

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goal of this study is to check the effecivity, feasibility and toxicity of the chemoradiotherapy and hyperthermia

Detailed Description

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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

Conditions

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Feasibilitystudy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. med. Daniel Zips

Prof.Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Zips, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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UKT_RO_HT_01

Identifier Type: -

Identifier Source: org_study_id

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