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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
radiochemotherapy with 70 Gy
radiochemotherapy with 77 Gy
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring Local control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tuebingen university, radiation oncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard therapy

dose escalation

Arm Description

Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)

Standard plus 10% dose escalation to the hypoxic volume

Outcomes

Primary Outcome Measures

time to local recurrence

Secondary Outcome Measures

Full Information

First Posted
January 28, 2015
Last Updated
January 30, 2015
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT02352792
Brief Title
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Official Title
Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of the Head and Neck
Keywords
Local control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy
Arm Type
Active Comparator
Arm Description
Standard radiochemotherapy (70 Gy, 5-fluorouracil 600 mg/m2 d1-5, mitomycin C d1+36 or cisplatinum 40 mg/m2 weekly for 5 weeks)
Arm Title
dose escalation
Arm Type
Experimental
Arm Description
Standard plus 10% dose escalation to the hypoxic volume
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy with 70 Gy
Intervention Type
Radiation
Intervention Name(s)
radiochemotherapy with 77 Gy
Primary Outcome Measure Information:
Title
time to local recurrence
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Zips, Prof. Dr. med.
Phone
+49 7071 29 82141
Email
daniel.zips@med.uni-tuebingen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Silke Theden, Mrs.
Phone
+49 7071 29 83420
Email
silke.theden@med-uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Welz, Dr. med.
Organizational Affiliation
radiation oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuebingen university, radiation oncology
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Welz, Dr. med.
Phone
+49 7071 29 86144
Email
stefan.welz@med.uni-tuebigen.de

12. IPD Sharing Statement

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

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