Phase III, double-blind, placebo-controlled study of post-operative adjuvant concurrent chemo-radiotherapy with or without nimotuzumab for stage III/IV head and neck squamous cell cancer - IHN01

Tata Memorial Centre0 个研究点目标入组 710 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•*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

•*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

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