Register Study of the Neoadjuvanten Treatment by Patients... | NCT03428867

Studies
Register Study of the Neoadjuvanten Treatment by Patients With Rectumcarcinoma

NCT03428867

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Feb 13, 2018Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Feasibilitystudy

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jul 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

Feb 5, 2018

First Submission Date that Met QC Criteria

Feb 5, 2018

First Posted Date

Feb 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2018

Last Update Posted Date

Feb 13, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. med. Daniel Zips, Prof.Dr. med., University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Measure	Description	Time Frame
remission		5 years

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patient with rectumcarcinoma stage UICC II+III

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Zips, Prof.Dr.	University Hospital Tuebingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen		Tübingen	Baden-Wurttemberg	72070	Germany