A Pilot Study of Induction Chemotherapy Followed by Surgery for Locally Advanced Resectable Head and Neck Cancer
An important observation of the induction triple chemotherapy regimen know as TPF is that
there was an unprecedented high proportion of patients treated who had a complete response
of their disease upon the completion of the induction phase. In a recent study by Haddad, et
al., a biopsy was performed in all patients following induction chemotherapy and before
starting concomitant chemoradiotherapy. Patients with an incomplete response to
chemoradiotherapy or who had N3 disease had a neck dissection 6 to 12 weeks after
chemoradiotherapy. Twenty-nine neck dissections were performed after chemoradiotherapy. The
neck dissection result was pathologically positive in 7 (24%) patients (all alive with no
evidence of disease) and negative in 22 (76%) patients (21 alive with no evidence of
disease). Post-TPF, primary site biopsy result was negative in 64 patients (89%) and
positive in 8 patients (11%). While the protocol required all patients to subsequently
receive concomitant chemoradiation regardless of disease response to the induction component
of the regimen, it is reasonable to question whether the complete responder subset really
needed to undergo the same intensive chemoradiation treatment compared to the partial
responders. Thus, a less intense therapy may be sufficient. The long term goal of this
protocol is to alter the model of highly effective cancer therapy from what is maximally
tolerated by the patient to what is minimally necessary for a cure.
One treatment strategy for patients with advanced head and neck cancer who prove to be
highly sensitive to chemotherapy is to combine the modalities of polychemotherapy and
conservation surgery with the goal of avoiding radiation therapy. For those patients whose
primary disease is classified as T2-3 (resectable), and who have a complete response
following induction therapy, it is feasible to perform an organ preservation tumor
nidusectomy at the primary site to verify that the clinical complete response is truly
pathological complete response. Similarly, the clinical complete response observed for the
associated nodal disease, can be verified pathologically by performing a selective neck
dissection without causing significant morbidity. Both tumor nidusectomy and selective neck
dissection has been shown to be an effective adjuvant in this setting. Building on these
observations, the novel protocol outlined in this proposal has the potential to spare the
use of radiation therapy for selective patients who have a complete response to induction
chemotherapy and thereby improve their well being without compromising survival.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Rate of pathologic complete response
To assess the rate of pathologic complete response of subjects (based on analysis of the surgical specimen), in both the primary site as well as the lymph nodes, with resectable stage III-IV squamous cell carcinoma of the oropharynx treated with TPF induction chemotherapy followed by conservation (organ preservation) surgery for clinically complete responders
42 months
No
K. T. Robbins, M.D.
Principal Investigator
Southern Illinois University School of Medicine
United States: Institutional Review Board
ROB-SCCI 10-001-1
NCT01111942
February 2010
December 2015
Name | Location |
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Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |