Brief Summary

The trial will compare the efficacy and safety of concomitant chemoradiation with tirapazamine, cisplatin and radiation versus cisplatin and radiation.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

317

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Apr 2005

Typical duration for phase_3

Geographic Reach

17 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

Study Start

First participant enrolled

April 1, 2005

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed

Last Updated

May 26, 2016

Status Verified

April 1, 2016

Enrollment Period

2.8 years

First QC Date

September 13, 2005

Last Update Submit

April 27, 2016

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

TirapazamineHead and Neck CancerCisplatinRadiation

Outcome Measures

Primary Outcomes (1)

Overall survival
Study period

Secondary Outcomes (4)

Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure
Study period
Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy
Study period
Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy
Study period
Toxicity and Safety
Study period

Study Arms (2)

Tirapazamine + Cisplatin

EXPERIMENTAL

Drug: TirapazamineDrug: Cisplatin

Cisplatin

ACTIVE COMPARATOR

Drug: Cisplatin

Interventions

TirapazamineDRUG

in combination with cisplatin and concomitant radiation

Also known as: SR259075

Tirapazamine + Cisplatin

CisplatinDRUG

with concomitant radiation

CisplatinTirapazamine + Cisplatin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Previously untreated squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
Stage III or IV disease (excluding T1N1, and T2N1 and metastatic disease).
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
Absolute neutrophil count at least 1.5 X 10\^9/L, platelet count at least 100 X 10\^9/L, and hemoglobin \> 9g/dL.
Serum bilirubin \< 1.25 times upper limit of normal (ULN) and aspartate aminotransferase (AST)/alanine transaminase (ALT) \< 2.5 times ULN.
Calculated creatinine clearance (Cockcroft-Gault) \> 55 mL/min.

You may not qualify if:

Metastatic Disease
Primary cancers of the nasal and paranasal cavities and of the nasopharynx
Significant intercurrent illness that will interfere with the Chemotherapy or Radiation Therapy during the trial
Symptomatic peripheral neuropathy \> grade 2
Clinically significant hearing impairment
Significant cardiac disease

Contact the study team to confirm eligibility.