Hypoxia-based Dose Escalation With Radiochemotherapy in H... | NCT02352792

Studies
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer

NCT02352792

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Feb 2, 2015Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Squamous Cell Carcinoma of the Head and Neck

Interventions

radiochemotherapy with 70 Gy
radiochemotherapy with 77 Gy

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

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jan 28, 2015

First Submission Date that Met QC Criteria

Jan 30, 2015

First Posted Date

Feb 2, 2015Estimated

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

Jan 30, 2015

Last Update Posted Date

Feb 2, 2015Estimated

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

Patients with locally advanced suqamous cell carcinoma of the head and neck region receive a hypoxia scan either by magnetic resonance tomography, computed tomography or fluoromisonidazole (FMISO)-PET-CT. Patients presenting with hypoxia are randomized into standard therapy consisting of intensity modulated radiotherapy (IMRT) with 70 Gy plus either 5-fluorouracil/mitomycin C or cisplatinum (Arm A) or a dose escalation of 10% (77Gy) to the hypoxic volume applied via simultaneous integrated boost in addition to the standard treatment (Arm B).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard therapy	Active Comparator	Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)	Radiation: radiochemotherapy with 70 Gy
dose escalation	Experimental	Standard plus 10% dose escalation to the hypoxic volume	Radiation: radiochemotherapy with 77 Gy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiochemotherapy with 70 Gy	Radiation		Standard therapy
radiochemotherapy with 77 Gy

Measure	Description	Time Frame
time to local recurrence		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

histologically verified squamous cell carcinoma of the head and neck region stage III and IV eligible for primary radiochemotherapy
measurabel disease by CT and/or MRT and/or FDG-PET-CT
fit for chemotherapy
no prior radiotherapy or major surgery in the head/neck region
Karnofsky Index > 60%
informed consent

Exclusion Criteria:

uncontrolled secondary cancer
distant metastases
pregnancy
expected malcompliance

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Zips, Prof. Dr. med.	Contact	+49 7071 29 82141		daniel.zips@med.uni-tuebingen.de
Silke Theden, Mrs.	Contact	+49 7071 29 83420		silke.theden@med-uni-tuebingen.de

Overall Officials

Name	Affiliation	Role
Stefan Welz, Dr. med.	radiation oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuebingen university, radiation oncology	Recruiting	Tübingen	Baden-Wurttemberg	72076	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000077195	Squamous Cell Carcinoma of Head and Neck

Ancestor Terms

ID	Term
D002294	Carcinoma, Squamous Cell
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059248	Chemoradiotherapy

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy
D011878	Radiotherapy

Browse Leaves

Not provided

Browse Branches

Not provided