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Completed

NCT Number: NCT00174837

TRACE: Tirapazamine-Radiation And Cisplatin Evaluation

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

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

tirapazamine

Drug

in combination with cisplatin and concomitant radiation

Other names: SR259075

Cisplatin

Drug

with concomitant radiation

Primary outcomes

  1. Overall survival

    Time frame: Study period

Secondary outcomes

  1. Failure Free Survival, Time To Loco-Regional Failure, Patterns of Failure

    Time frame: Study period

  2. Initial Response Rates at 2 Months After Completion of Chemoradiation Therapy, Final complete response (CR) Rate at Six Months After Completion of Therapy

    Time frame: Study period

  3. Change in QoL From Baseline, Percent of Patients Who Are Feeding Tube Dependent 12 Months After Completion of Therapy

    Time frame: Study period

  4. Toxicity and Safety

    Time frame: Study period

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Groupe Oncologie Radiotherapie Tete et Cou

Registry information

Official study title

Phase III Randomized Trial of Concomitant Radiation, Cisplatin, and Tirapazamine Versus Concomitant Radiation and Cisplatin in Patients With Advanced Head and Neck Cancer

Acronym: TRACE

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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