Health Condition 1: null- Locally Advanced Oro-pharyngeal, Laryngeal and Hypopharyngeal cancer patients eligible for concurrent chemo-radiation
Conditions
Interventions
Intervention1: The hypoxic radio-sensitizer Nimorazole will be given along with concurrent chemo-radiation: Locally advanced Oropharyngeal, laryngeal and Hypopharyngeal cancers will be given the gold
Sponsors
Amrita Institute of Medical Sciences and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1)Tumour classified as stage III-IV located in oropharynx, hypopharynx and larynx according to the TNM classification. 2) Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour. 3) Age > 18 years and 4) Informed consent according to the Helsinki declaration and institutional regulations. 5) The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment. 6) Performance status 0-2 according to WHO criteria. 7) The patient should not have symptoms of peripheral neuropathy assessed by clinical examination. 8) Normal function of liver and kidney by routine laboratory examinations. 9) The patient must not be pregnant.
Exclusion criteria
Exclusion criteria: 1) Distant metastases. 2) The patient should not have any other co-morbidities or conditions that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy. 3) Surgical excision (except biopsy), prior or planned (including elective neck dissection). 4) The existence of synchronous multiple malignancies (not leucoplakia). 5) Use of Vitamin K agonists (since 5-nitroimidazoles are inhibitors of CYP2C9).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study Loco-regional Control of diseaseTimepoint: 5 years from completion of definitive treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Overall Survival 2) Test Osteopontin as a marker for hypoxia to predict efficacy of Nimorazole. 3) Identify a correlation between sensitivity to radiation and p53 mutations in hypoxic tumours.Timepoint: 5 years from completion of definitive treatment | — |
Countries
India
Contacts
Public ContactDr Aswin George Abraham
Amrita Institute of Medical Sciences and Research, Kochi, Kerala
Outcome results
None listed