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New treatment option for Oropharynx Cancer
Official title Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.
ClinicalTrials.gov ID: NCT04277858
What this study is testing
What is Docetaxel?
Docetaxel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for oropharynx cancer.
Also referred to as Cisplatin, Transoral robotic surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.