What side effects are associated with this type of intervention?

The most common treatments for throat cancer, such as chemo-radiotherapy, are associated with significant lifelong side effects including tissue damage from radiotherapy, leading to issues like dysphagia (difficulty swallowing), xerostomia (dry mouth), chronic pain, and vocal cord palsy. These side effects can severely impact the patient's quality of life. In contrast, the combination of neoadjuvant chemotherapy followed by Transoral Robotic Surgery (TORS) aims to reduce these side effects by avoiding radiotherapy in most cases. This approach is hypothesized to offer a competitive cure rate with fewer than 10% failure rate and better functional and quality of life outcomes.

What prior FDA approvals exist?

The FDA has approved several chemotherapy drugs for the treatment of throat cancer, including cisplatin, carboplatin, and docetaxel, which are often used in combination with radiation therapy or as part of a neoadjuvant approach to reduce tumor size before surgery. Transoral Robotic Surgery (TORS) is a minimally invasive surgical technique that has been increasingly adopted for the treatment of oropharyngeal cancer, particularly in cases associated with human papillomavirus (HPV). While specific FDA approvals for the combination of neoadjuvant chemotherapy followed by TORS are not detailed, the individual components—chemotherapy agents and the TORS technique—are recognized and utilized in clinical practice for the management of throat cancer.

What other types of research exist?

Promising novel alternatives to Neoadjuvant Chemotherapy followed by Transoral Robotic Surgery (TORS) for throat cancer patients include: 1) Concurrent chemoradiation, which combines chemotherapy with radiation therapy to enhance treatment efficacy. 2) Dose-reduced adjuvant radiation therapy, which aims to minimize long-term toxicity while maintaining treatment effectiveness. 3) Endoscopic interventions such as photodynamic therapy and self-expanding metal stent (SEMS) placement for palliation of dysphagia. These approaches offer potential benefits in terms of reduced side effects and improved quality of life.

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Anti-mitotic Agent

Chemotherapy + Robotic Surgery for Throat Cancer (NECTORS Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for throat cancer, particularly neoadjuvant chemotherapy followed by Transoral Robotic Surgery (TORS), work through distinct but complementary mechanisms. Chemotherapy uses drugs to target and kill rapidly dividing cancer cells, thereby reducing the tumor size. This makes the tumor easier to remove surgically. TORS is a minimally invasive surgical technique that employs robotic systems to precisely excise the tumor, minimizing damage to surrounding tissues. This combination is significant for throat cancer patients as it aims to achieve a high cure rate while preserving critical functions such as speech and swallowing, and reducing the long-term side effects often associated with traditional chemoradiotherapy.

Phase 2

Recruiting

Research Sponsored by Nader Sadeghi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Squamous cell cancer of oropharynx, p 16 positive

Treatment Naive

Must not have

Patients with advanced T4 cancer unresectable without organ preservation

Concurrent infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for advanced throat cancer caused by HPV. It uses chemotherapy first, then a precise robotic surgery to remove the cancer. This method aims to reduce the severe side effects of traditional treatments and improve patients' quality of life. Transoral robotic surgery (TORS) has become an accepted initial treatment for T1 and T2 head and neck squamous cell carcinoma (HNSCC).

Who is the study for?

This trial is for adults over 18 with HPV-related oropharyngeal cancer (cancer in parts of the throat like tonsils and tongue), who are fit for surgery, have not had previous treatments, and no distant spread of cancer. They must be able to perform daily activities mostly without aid (Karnofsky >60% or ECOG <2) and agree to use contraception.

What is being tested?

The study tests if chemotherapy followed by Transoral Robotic Surgery (TORS) can effectively treat oropharyngeal cancer with fewer side effects than current chemo-radiotherapy methods. The goal is a high cure rate with less than a 10% failure rate, avoiding radiotherapy in most cases.

What are the potential side effects?

Potential side effects include those related to Docetaxel chemotherapy such as fatigue, nausea, hair loss, low blood cell counts leading to increased infection risk, mouth sores, and neuropathy (nerve problems). Surgical risks involve bleeding, infection and complications from anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My throat cancer is p16 positive.

Select...

I have not received any treatment for my condition.

Select...

My cancer has not spread to distant parts of my body.

Select...

I am fit for surgery and my tumor can be completely removed through the mouth.

Select...

My blood tests show normal white cell, platelet counts, and kidney function.

Select...

I am older than 18 years.

Select...

I haven't had any cancer in the last 5 years, except for skin cancer.

Select...

I can care for myself and am up more than 50% of my waking hours.

Select...

My cancer is at a specific advanced stage (Stage III or early Stage IV).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My advanced cancer cannot be surgically removed without losing organ function.

Select...

I currently have an infection.

Select...

I have had head or neck cancer before, but not skin cancer.

Select...

My cancer has spread to distant parts of my body.

Select...

Doctors cannot reach my tumor through my mouth due to its location.

Select...

My tumor is P16 negative.

Select...

I have 5 or more cancerous lymph nodes in my neck.

Select...

My cancer is at stage IVB according to AJCC-7.

Select...

My cancer has spread outside the lymph node.

Select...

I have mild or no nerve damage symptoms.

Select...

I have previously been treated with Taxanes or Cisplatin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

: progression free survival.

Secondary study objectives

Disease Specific Survival (DSS)

General Quality of Life (QOL)

Head and Neck Specific Quality of Life (QOL)

+1 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neoadjuvant chemotherapy and surgeryExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for throat cancer, particularly neoadjuvant chemotherapy followed by Transoral Robotic Surgery (TORS), work through distinct but complementary mechanisms. Chemotherapy uses drugs to target and kill rapidly dividing cancer cells, thereby reducing the tumor size. This makes the tumor easier to remove surgically. TORS is a minimally invasive surgical technique that employs robotic systems to precisely excise the tumor, minimizing damage to surrounding tissues. This combination is significant for throat cancer patients as it aims to achieve a high cure rate while preserving critical functions such as speech and swallowing, and reducing the long-term side effects often associated with traditional chemoradiotherapy.