Study of Post-Op Adjuvant Concurrent Chemo-RT With or Without Nimotuzumab for Head & Neck Cancer

• Status: Active, not recruiting
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to improve the loco-regional control rate and overall survival of locally advanced head and neck squamous carcinoma (HNSCC). The investigators hypothesize that the addition of nimotuzumab (a recombinant humanized murine immune antibody that blocks both epidermal growth factor (EGF) and transforming growth factor (TGF)) to the current gold standard of concurrent chemoradiotherapy (CCRT) (7)(8), an adjuvant setting in patients after resection of their locally advanced HNSCC will confer therapeutic advantage.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Centre, Singapore
• Collaborators: Innogene Kalbiotech Pte. Ltd; National Medical Research Council (NMRC), Singapore
• Treatments: Nimotuzumab

Criteria

Inclusion Criteria:

• Age should be greater than or equal to the minimum age of consent in the applicable country

• 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 creatininecreatinine 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:

• 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.