Recruiting
Phase 2

Chemotherapy & Surgery

Sponsor:

Nader Sadeghi

Code:

NCT04277858

Conditions

Oropharynx Cancer

Tonsil Cancer

Throat Cancer

Base of the Tongue Carcinoma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Docetaxel

Study Details

Brief summary:

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.

Conditions

Oropharynx Cancer

Tonsil Cancer

Throat Cancer

Base of the Tongue Carcinoma

Study ID

NCT04277858

Start date

Aug 14, 2018

Status verified date

Oct, 2023

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Fit for surgery, and primary tumor assessed surgically resectable with negative margins via transoral approach
  • Age > 18 years
  • Karnofsky performance status > 60% or Eastern Cooperative Oncology Group (ECOG) < 2
  • Absolute neutrophil count (ANC) > 2,000, platelets > 100,000 and calculated creatinine clearance > 50 cc/min
  • Signed study specific consent form
  • No other malignancies except cutaneous basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the last 5 years
  • Agree to use effective contraception while on the study. Women of child bearing potential must have a negative pregnancy test, and not be lactating.

Exclusion Criteria:

  • 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
  • Distant metastatic disease (Stage IVC)
  • Radiological evidence of gross extracapsular nodal tumor invasion
  • Anatomy not allowing transoral access and exposure
  • Prior head and neck cancer at any time (Other than BCC or SCC of skin)
  • Coexistent second malignancy or history within 5 years of prior malignancy (other than BCC or early SCC skin or curatively treated Stage I carcinoma of cervix)
  • Peripheral neuropathy >/= grade 1
  • Have had prior Taxanes or Cisplatin
  • Concurrent infection
  • Coexisting medical illness of a severity that might interfere with treatment or follow-up, or who do not have the ability to give informed consent.
  • Receiving any other investigational agent while on the study

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neoadjuvant chemotherapy and surgery

Docetaxel and Cisplatin x 3 cycles followed by Transoral robotic surgery and neck dissection.

Carboplatin may be used instead of Cisplatin.

Interventions

Docetaxel

Subjects 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.

Primary outcome measure

  • Primary outcome: progression free survival. [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Nader Sadeghi, MD

514-934-1934nader.sadeghi@mcgill.ca

Elizabeth Beaubien

514-934-1934

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Nader Sadeghi

5149341934nader.sadeghi@mcgill.ca

Elizabeth Beaaubien

514-934-1934elizabeth.beaubien@muhc.mcgill.ca

More Information

Sponsor

Nader Sadeghi

Last update posted

Oct 23, 2023

Last verified

Oct, 2023

Keywords

  • oropharynx cancer
  • throat cancer
  • HPV related throat cancer
  • tonsil cancer
  • base of tongue cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nader Sadeghi on 2023-10-23.