Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Cancer.

Launched by NADER SADEGHI · Feb 19, 2020

Keywords

ClinConnect Summary

**Summary of the Clinical Trial on Oropharyngeal Cancer Treatment**

This clinical trial is exploring a new treatment approach for oropharyngeal cancer, which includes cancers of the throat, tonsils, and base of the tongue, particularly those related to the human papillomavirus (HPV). The study is focused on treating patients with chemotherapy first, followed by a specialized surgery called Transoral Robotic Surgery (TORS). This method aims to improve treatment effectiveness while reducing the long-term side effects that often come with traditional treatments like chemotherapy and radiation. Researchers believe that this new approach could lead to a lower chance of cancer returning and may also help patients maintain a better quality of life.

To participate in this trial, candidates must be at least 18 years old and diagnosed with a specific type of oropharyngeal cancer that is HPV-positive and meets certain staging criteria. They should not have received any prior treatment for their cancer and should be healthy enough for surgery. Participants will receive chemotherapy before surgery and will be closely monitored throughout the process. This trial is currently recruiting participants, and it's important for those interested to discuss their eligibility with their healthcare provider to understand the potential benefits and risks involved.

Gender

ALL

Eligibility criteria

• 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