Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-03-05 @ 3:31 AM
Study NCT ID:
NCT02352792
Status:
UNKNOWN
Last Update Posted:
2015-02-02
First Post:
2015-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoxia-based Dose Escalation With Radiochemotherapy in Head and Neck Cancer
Sponsor:
University Hospital Tuebingen
Organization:
Study Overview
Official Title:
Randomized Phase II Study for Dose Escalation in Locally Advanced Head and Neck Squamous Cell Carcinomas Treated With Radiochemotherapy
Status:
UNKNOWN
Status Verified Date:
2015-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: