Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
7 September 2021 |
Main ID: |
EUCTR2004-002017-37-ES |
Date of registration:
|
23/05/2006 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Phase III randomized trial of concomitant radiation, cisplatin, and tirapazamine (SR259075) versus concomitant radiation and cisplatin in patients with advanced head and neck cancer - TRACE
|
Scientific title:
|
Phase III randomized trial of concomitant radiation, cisplatin, and tirapazamine (SR259075) versus concomitant radiation and cisplatin in patients with advanced head and neck cancer - TRACE |
Date of first enrolment:
|
04/05/2005 |
Target sample size:
|
550 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002017-37 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
Countries of recruitment
|
Belgium
|
Germany
|
Hungary
|
Italy
|
Spain
| | | |
Contacts
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
|
Name:
|
|
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx Stage III or IV disease (excluding T1N1, T2N1 and metastatic disease)
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: ECOG>2 Non adequate renal, hepatic or hematologic function Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy during the trial such as HIV infection, cardiac insufficiency, pulmonary compromise, active alcohol abuse, active infection or febrile illness History of myocardial infarction, history of ventricular arrhytmias, angina or active coronary heart disease within 6 months, active peripheral claudition within 6 months Primary cancers of the nasal and paranasal cavities and of the nasopharynx Distant metastasis Prior systemic chemotherapy for cancer Prior radiation for head and neck cancer prior experimental therapy for cancer within 30 days of entereing the trial
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Oncology: Advanced Head and Neck cancer MedDRA version: 7.0
Level: LLT
Classification code 10025960
|
Intervention(s)
|
Product Name: Tirapazamine Product Code: SR259075 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Tirapazamine CAS Number: 27314-97-2 Current Sponsor code: SR259075 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.7-
Trade Name: CISPLATINO Product Name: Cisplatin Pharmaceutical Form: Solution for infusion INN or Proposed INN: Cisplatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1-
|
Primary Outcome(s)
|
Primary end point(s): Primary endpoint: Overall Survival
|
Main Objective: The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin, and radiation versus cisplatin and radiation. Primary endpoint: Overall Survival
|
Secondary Objective: Secondary endpoints: Failure free survival, time to locoregional failure, patterns of failure, toxicity and safety, Initial response rates, final CR, Change in QOL
|
Secondary ID(s)
|
EFC5512
|
2004-002017-37-HU
|
Source(s) of Monetary Support
|
Ethics review
|
Status: Approved
Approval date: 12/04/2005
Contact:
|
|