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OpenTrials
Completed

NCT Number: NCT03428867

Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma

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

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Key information

Conditions

Feasibilitystudy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, 72070, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. remission

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Phase II Studie Zur Neoadjuvanten Trimodalen Hyperthermen Radiochemotherapie Des Tief Sitzenden Rektumskarzinoms im Stadium UICC II + III

Acronym: HT01

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2018
Registry last updated
Feb 13, 2018

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.