Phase II Trial of Induction Chemotherapy (ICT) Followed by Concurrent Chemoraditherapy (CR) With Monoclonal Antibody Cetuximab in Locally Advanced Head and Nec Squamous Cell Cancer
Chemotherapy would be used in two phases. In the initial phase all patients would be treated
with ICT involving 6 cycles of PCC. This involves Cetuximab 400mg/m2 Week 1 and then
250mg/m2 weekly, Paclitaxel 80mg/m2 weekly and carboplatin AUC 2 weekly for 6 weeks followed
by concurrent chemoradiotherapy with cetuximab. After ICT patients would be given weekly
Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 concurrent with radiation therapy.
Typically for tumors treated by megavoltage (6MV) radiotherapy alone or with chemotherapy,
the primary tumor bed with an adequate margin and the draining lymphatics will be treated
with parallel opposed lateral treatment portals; the lower neck node bearing area will be
treated through an anterior port. The standard total dose for the targeted tumor bed and
electively treated lymphatics is 50 Gy/25 fractions, and then, an additional boost dose to
the neoplasm-bearing site(s) of 16 Gy to 20 Gy.
The total dose received by the spinal cord should not be allowed to exceed 46 Gy. For N1 to
N3 disease, they also shall need a total dose (boost included) of 66 Gy and perhaps up to 70
Gy if it can be safely given 6.4 Study Outline:
1. Patients who are deemed eligible and sign informed consent would be enrolled in the
2. Prior to starting therapy staging PET/CT scan, medical history, physical exam,
hematologic and biochemical testing will be undertaken.
3. Since mucositis and oropharyngeal dysfunction is very likely with chemo-radiation PEG
tube placements will be considered prior to treatment, in order to allow adequate
nutrition in case of mucositis.
4. Prior to starting radiation patients would undergo dental evaluation which is a
5. Patients would then undergo 6 weeks of ICT using PCC. Based on toxicity dose would be
modified as described in section 8.
6. For PCC regimen, cetuxmiab would be given first followed by paclitaxel and then
carboplatin using standard pre-medication.
7. A CT scan (no PET scan) of the head and neck will be performed during the evaluation
Week 7 on any day of that week.
8. Following induction chemotherapy patients would be treated with radiation therapy of up
to 70 Gy concurrent with weekly Cisplatin at 30mg/m2 and cetuximab at 250mg/m2 for the
duration of radiation therapy. Again dose modifications would be performed based as
described in section 8.
9. Cetuximab would be administered first followed by cisplatin concurrent with radiation.
10. History and Physical examination would be performed at the end of treatment to document
response and assess toxicity
10. Patient with residual disease at the primary site or neck after completion of
chemoradiotherapy would be offered surgery.
11. Week 26 (3 months) after completion of radiation therapy a repeat PET scan will be
performed to assess response which is standard of care.
12. After completion of all treatment patients will be followed at every 3 months interval
to document relapse or manage toxicities from treatment.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Analysis at Week 26
Syed H Jafri, MB,B,S
United States: Institutional Review Board
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