Health Condition 1: null- Head and Neck Squamous Cell Cancer
Conditions
Interventions
Intervention1: Nimotuzumab: Administered by intravenous infusion at 200 mg absolute per dose, diluted in 250 ml of sodium chloride over 30 minutes. 8 weekly doses of study drug will be given, beginnin
Sponsors
Regional Cancer Centre
Innogene Kalbiotech
Eligibility
Inclusion criteria
Inclusion criteria: *Age less than or equal to 70 years old *Histologically proven head and neck squamous cell cancer (excluding nasopharynx, salivary glands, paranasal sinuses and unknown primaries) on biopsy of the primary lesion or the neck mass. *Resectable stage III/IV according to the AJCC/UICC staging system with no evidence of distant metastasis. *Complete macroscopic resection. *Patients should have at least one of the following pathological features for inclusion: pT3 or pT4 and any nodal stage (N), except T3N0 of the larynx, with negative resection margins, or a tumor stage of 1 or 2 with a nodal stage of 2 or 3 and no distant metastasis (M0); patients with stage T1 or T2 and N0 or N1 who had unfavorable pathological findings (extranodal spread, positive resection margins, perineural involvement, or vascular tumor embolism) are also eligible, as are those with oral-cavity or oropharyngeal tumors with involved lymph nodes at level IV or V. *Performance status must be ECOG 0 or 1. Patients should be able to tolerate chemotherapy and radiotherapy. *Adequate bone marrow, renal and hepatic function: 1.WBC>3000/mm3, platelets>100000/mm3 2.Serum creatinine<upper limit of normal range as per institution and calculated creatinine clearance (according to the Cockcroft and Gault method) >50 ml/min. 3.SAP, SGOT<2 x upper limit of normal range, bilirubin <1.5 x upper limit of normal range. *Written informed consent
Exclusion criteria
Exclusion criteria: *Histology other than SCC or its subtype. *Patients with disease subsite deemed suitable for organ preservation approach, namely stage III/IV laryngeal or hypopharyngeal carcinoma with not more than low-volume T4 disease; low-volume T4 disease is defined as disease not eroding into cartilage or extending not more than 1 cm into the base of tongue. *Clinical or radiological evidence of distant metastasis. *Uncontrolled comorbidities such as diabetes mellitis, hypertension, cardiac disease. *Uncontrolled infection. *Uncontrolled hypercalcemia. *Prior history of cancer less than 5 years ago or a synchronous primary outside the head and neck area. *Prior treatment, head and neck radiotherapy, chemotherapy or surgery (excluding biopsy) or anti-EGFR therapy such as cetuximab/EGFR oral tyrosine kinase inhibitor. *Patients for whom compliance with follow-up is unlikely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival (DFS)Timepoint: Defined as the time from randomization to the time of initial detection of relapse or death from any cause. A patient is only considered to have an event if the relapse or death occurs after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS)Timepoint: Defined as the time from randomization until death from any cause or to the time when the patient is last seen to be alive.;ToxicityTimepoint: Assessed till 30 days from the last day of study treatment | — |
Countries
Australia, India
Contacts
Public ContactDr Yashesh Mehta
Principal Investigator
Outcome results
None listed