Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
ID04277858

Phase II Study of Induction Chemotherapy Followed by Transoral Robotic Surgery and Neck Dissection for Oropharyngeal Squamous Cell Carcinoma

Led by Nader Sadeghi · Updated on 2023-10-23

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

N

Nader Sadeghi

Lead Sponsor

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new treatment approach for human papilloma virus (HPV) related oropharyngeal cancer, focusing on advanced stages (III and IV) of oropharyngeal squamous cell carcinoma positive for p16. This study aims to compare the effectiveness of neoadjuvant chemotherapy followed by Transoral Robotic Surgery (TORS) and neck dissection with the current standard treatment of chemoradiotherapy, which has significant lifelong side effects and a 20% failure rate. The goal is to achieve similar or better cure rates with fewer side effects and improved quality of life. Participants will receive three cycles of neoadjuvant chemotherapy using docetaxel and cisplatin (or carboplatin as an alternative), followed by transoral robotic surgery and neck dissection to remove the cancer. This approach is designed to avoid or reduce the need for radiotherapy, which often causes long-term complications. Radiotherapy will be reserved only for salvage treatment if needed. This study represents a new treatment paradigm aiming to improve functional outcomes and reduce the harmful effects caused by radiation. During the trial, participants will be monitored for progression-free survival over two years, with additional assessments of disease-specific and overall survival over five years. Quality of life will be evaluated over 12 months using general and head and neck specific measures. Researchers will assess the effectiveness of the treatment and its impact on patients' function and well-being. Participants will undergo surgery, chemotherapy, and regular follow-ups to track cancer status and side effects throughout the study period.

CONDITIONS

Brief Title

Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Squamous cell cancer of oropharynx, p16 positive
  • AJCC-7 Stage III (T1N1, T2N1, T3N0, T3N1) or stage IVa (T1N2, T2N2, T3N2)
  • Treatment naive
  • No distant metastatic disease
  • Fit for surgery with tumor resectable via transoral approach
  • Age greater than 18 years and up to 80 years
  • Karnofsky performance status greater than 60% or ECOG less than 2
  • Absolute neutrophil count over 2,000, platelets over 100,000, and creatinine clearance over 50 cc/min
  • Signed study consent form
  • No other malignancies except cutaneous basal cell carcinoma or squamous cell carcinoma within last 5 years
  • Agree to use effective contraception; women must have negative pregnancy test and not be lactating
Not Eligible

You will not qualify if you...

  • Advanced T4 cancer unresectable without organ preservation
  • P16 negative tumor
  • N3 disease (Stage IVB AJCC-7)
  • Five or more positive cervical lymph nodes
  • Distant metastatic disease (Stage IVC)
  • Gross extracapsular nodal tumor invasion on imaging
  • Anatomy preventing transoral access
  • Prior head and neck cancer except BCC or SCC of skin
  • Coexistent second malignancy or prior malignancy within 5 years except BCC or early SCC skin or treated Stage I cervical carcinoma
  • Peripheral neuropathy grade 1 or higher
  • Prior treatment with Taxanes or Cisplatin
  • Concurrent infection
  • Severe medical illness interfering with treatment or follow-up
  • Receiving other investigational agents during the study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of 3 chemotherapy cycles followed by surgery

Participants receive neoadjuvant chemotherapy with docetaxel and cisplatin for 3 cycles followed by transoral robotic surgery and neck dissection as definitive treatment. Radiotherapy is reserved for salvage if needed.

Multiple visits for chemotherapy cycles and surgery

Follow-up

Duration - Up to 5 years

Participants are monitored for disease progression, survival, and quality of life after treatment.

Visits to assess progression-free survival, disease-specific survival, overall survival, and quality of life over 12 months and beyond

Trial Site Locations

Total: 1 location

1

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

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Research Team

N

Nader Sadeghi, MD

E

Elizabeth Beaubien

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

Neoadjuvant chemotherapy and transoral surgery as a definitive treatment for oropharyngeal cancer: A feasible novel approach.

Nader Sadeghi, Ning-Wei Li, M Reza Taheri...

https://pubmed.ncbi.nlm.nih.gov/27299983