Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

NCT04277858 | Recruiting Phase 2

• 1 other identifier: MP-37-2018-3443
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  2 years

Secondary Outcomes (4)

• Disease Specific Survival (DSS)

  5 years

• Overall Survival (OS)

  5 years

• General Quality of Life (QOL)

  12 months.

• Head and Neck Specific Quality of Life (QOL)

  12 months

Study Arms (1)

Neoadjuvant chemotherapy and surgery

EXPERIMENTAL

Docetaxel and Cisplatin x 3 cycles followed by Transoral robotic surgery and neck dissection. Carboplatin may be used instead of Cisplatin.

Drug: Docetaxel

Interventions

Docetaxel DRUG

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.

Also known as: Cisplatin, Transoral robotic surgery

Neoadjuvant chemotherapy and surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with advanced T4 cancer unresectable without organ preservation
• P16 negative tumor
• N3 disease (Stage IVB AJCC-7)
• 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

Sponsors & Collaborators

• Nader Sadeghi: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (3)

• Sadeghi N, Mascarella MA, Khalife S, Ramanakumar AV, Richardson K, Joshi AS, Taheri R, Fuson A, Bouganim N, Siegel R. Neoadjuvant chemotherapy followed by surgery for HPV-associated locoregionally advanced oropharynx cancer. Head Neck. 2020 Aug;42(8):2145-2154. doi: 10.1002/hed.26147. Epub 2020 Mar 25.

  PMID: 32212296 BACKGROUND

• Sadeghi N, Khalife S, Mascarella MA, Ramanakumar AV, Richardson K, Joshi AS, Bouganim N, Taheri R, Fuson A, Siegel R. Pathologic response to neoadjuvant chemotherapy in HPV-associated oropharynx cancer. Head Neck. 2020 Mar;42(3):417-425. doi: 10.1002/hed.26022. Epub 2019 Nov 27.

  PMID: 31773857 BACKGROUND

• Sadeghi N, Li NW, Taheri MR, Easley S, Siegel RS. Neoadjuvant chemotherapy and transoral surgery as a definitive treatment for oropharyngeal cancer: A feasible novel approach. Head Neck. 2016 Dec;38(12):1837-1846. doi: 10.1002/hed.24526. Epub 2016 Jun 14.

  PMID: 27299983 BACKGROUND

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Tonsillar Neoplasms

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Nader Sadeghi, MD

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

  STUDY CHAIR

Central Study Contacts

Nader Sadeghi, MD

CONTACT

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

Elizabeth Beaubien

CONTACT

514-934-1934

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: neoadjuvant Docetaxel and Cisplatin and transoral surgery

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: February 20, 2020
• Study Start: August 14, 2018
• Primary Completion: August 30, 2024
• Study Completion (Estimated): August 30, 2026
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CA (1)