Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNader Sadeghi
About this trial
The objective of this trial is to study the efficacy of treatment of human papilloma virus (HPV) related oropharyngeal cancer with chemotherapy followed by Transoral Robotic Surgery (TORS) as definitive treatment. Current treatment of oropharyngeal cancer are chemo-radiotherapy. There is significant lifelong side effects associated with this approach related to tissue effects of radiotherapy. The side effects results in significant quality of life deterioration among the patients. Overall there is 20% failure rate with this treatment approach. The study hypothesis is that treatment with upfront (neoadjuvant) chemotherapy followed by transoral surgery and neck dissection is highly effective treatment allowing competitive cure rate compared to chemo-radiotherapy with less than 10% failure rate, while avoiding radiotherapy in majority of cases. It is also hypothesized that better functional and quality of life outcome maybe achieved with this approach.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Squamous cell cancer of oropharynx, p 16 positive
American Joint Commission on Cancer version-7 (AJCC-7) Stage III (T1N1, T2N1, T3N0, T3N1) and stage IVa (T1N2, T2N2, T3N2)
Treatment Naive
No evidence of distant metastatic disease
Disqualifiers
Patients with advanced T4 cancer unresectable without organ preservation
P16 negative tumor
N3 disease (Stage IVB AJCC-7)
5 or more positive cervical lymph nodes at presentation
Trial design
Design model
Single group
Treatments tested in this trial
Docetaxel
DrugSubjects will be treated with neoadjuvant docetaxel and cisplatin for 3 cycles. This is followed by transoral robotic surgery (TORS) and neck dissection as definitive treatment, reserving radiotherapy for salvage.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant chemotherapy and surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary outcome: progression free survival.
Subjects will be evaluated for cancer recurrence or persistence. Index cancer recurrence or persistence following completion of treatment at any site will be recorded as an event. Progression free survival will be calculated at 2 years according to the Kaplan Meier methods.
Time frame
2 yearsSecondary outcomes
1
Disease Specific Survival (DSS)
The trial subjects will be followed for vital statistics (dead or alive) from the time enrolled in the trial. Any deaths that is caused by the index cancer will count as an event. DSS will be calculated with intention to treat analysis according to the Kaplan Meier methods at 5 years.
Time frame
5 years2
Overall Survival (OS)
The trial subjects will be followed for vital statistics (dead or alive) from the time of enrolment. Death from any cause will be counted as an event. Overall survival will be calculated according to the Kaplan Meier methods at years.
Time frame
5 years3
General Quality of Life (QOL)
Patient-reported general quality of life outcome will be measured according to The European Organization for Research and Treatment of Cancer (EORTC) general quality of life questionnaire (EORTC QLQ-C30) at 3 month, 6 months, and 12 months following the completion of treatment. These questionnaires are validated and an integrated system for assessing the quality of life (QoL) of cancer patients participating in clinical trials. Outcome score for functional scales at 12 months will be compared to pretreatment levels.
Time frame
12 months.4
Head and Neck Specific Quality of Life (QOL)
Patient-reported quality of life outcome will be measured according to EORTC head and neck specific questionnaire (QLQ-H\&N35) prior to trial treatment (baseline), at 3 month, 6 months, and 12 months following the completion of treatment. These questionnaires are validated and an integrated system for assessing the quality of life (QoL) of head and neck cancer patients participating in clinical trials. Outcomes for symptom scales in H\&N-35 at 12 months will be compared to pretreatment levels.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Nader Sadeghi
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor institution
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov