Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03428867

Acronym

HT01

Enrollment

Registered

2018-02-12

Start date

2012-08-31

Completion date

2017-07-31

Last updated

2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feasibilitystudy

Brief summary

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

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
remission	5 years

Countries

Germany

Outcome results