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Head and Neck CancerPhase 2NCT02760667

Induction Chemotherapy Followed by Surgery for Locally Advanced Head and Neck Cancer

A Phase 2 study testing Cisplatinum, Docetaxel and Carboplatin in people with Head and Neck Cancer, run by George Washington University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to assess the efficacy of induction chemotherapy followed by transoral surgical treatment and neck dissection, in definitive management of moderately advanced oropharyngeal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cisplatinum, Docetaxel and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jun 2015to 30 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, vallecula, soft palate) and supraglottis.
  • Stages III (T1N1, T2N1, T3N0, T3N1) and stage IVA (T1N2, T2N2, T3N2, very select earlyT4) disease not previously treated with any method (Surgery, Radiation or Chemotherapy)
  • No evidence of distant metastatic disease
  • Fit for surgery and primary tumor assessed surgically resectable (by surgical PI) via transoral approach
  • Age > 18 years
  • Karnofsky performance status > 60%, or ECOG < 2
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  • ANC > 2,000, platelets > 100,000 and calculated creatinine clearance >50 cc/min
  • Signed study specific consent form
  • Protocol begins within 4 weeks of biopsy and within 3 weeks of the latest medical imaging.
  • No other malignancies except cutaneous basal or squamous cell cancer within the last 5 years
  • Patients must have measurable disease based on RECIST.
  • Men and women of child bearing potential must agree to use effective contraception while on the study, and women must have a negative pregnancy test, and not be lactating.

Who cannot join

  • Patients with advanced T4 cancer judged unresectable by transoral approach by surgical PI.
  • Patients with N3 disease (Stage IVB).
  • Patients with distant metastatic disease (Stage IVC).
  • Patients with radiologically positive neck nodes with radiological evidence of extracapsular nodal tumor invasion.
  • Patients having anatomy not allowing transoral access and exposure for surgery(Judged by the surgical PI at the time of biopsy under general anesthesia)
  • Patients with prior head and neck cancer at any time (other than basal or squamous cell cancer of the skin)
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  • Coexistent second malignancy or history within 5 years of prior malignancy (other than basal or squamous cell cancer of the skin or curatively treated Stage I carcinoma of the cervix) renders the patient ineligible.
  • Patients with peripheral neuropathy >/= grade 1 will not be eligible for the study.
  • Patients who have had prior Taxanes or Cisplatin
  • Patients with concurrent infection are not eligible. All patients must be afebrile for at least 3 days prior to start of therapy unless fever is due to tumor.
  • Patients with 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.
  • Patients who have received prior radiation therapy, surgery and chemotherapy for the tumor being treated.
  • Patients must not be receiving any other investigational agent while on the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • George Washington University-Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: A Phase II Study of Induction Chemotherapy Followed by Surgical Treatment in Locally Advanced Oropharyngeal And Supraglotic Cell Carcinoma

The objective of this study is to assess the efficacy of induction chemotherapy followed by transoral surgical treatment and neck dissection, in definitive management of moderately advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary tumor, and neck dissection for the management of cervical lymph nodes.

The primary outcome measure will be disease specific survival (DSS). The secondary oncologic outcome measures will be locoregional control, relapse free survival, overall survival, and Quality of Life (QOL).

Read the detailed description

The current standard of care for advanced (stage III and IV) oropharyngeal squamous cell carcinoma are concomitant chemoradiation, or surgery followed by adjuvant radiation therapy with or without concomitant chemotherapy. These approaches have persistent and significant lifelong side effects and sequella related to treatment, and in particular radiotherapy. The side effects of radiotherapy (augmented with concomitant chemotherapy) include soft tissue fibrosis, loss of salivary function, dry mouth, life long disturbed taste function, poor dental health with rapidly decaying teeth, dysfunction of swallowing, significant loss of the mobility of the base of tongue and pharyngeal constrictors, loss of laryngeal elevation, esophageal stricture, and at times severe side effects such as soft tissue necrosis or osteoradionecrosis of the mandible. About 10% of the patients undergoing chemoradiation for oropharyngeal cancer develop long term swallowing dysfunction with feeding tube dependency. As a result , patient's quality of life (QOL) is adversely affected. Improvements in the side effect profile of treatment, the functional outcome, and the QOL remain very important areas of advancement in treating this patient population. Improvements in functional outcome need to be achieved while maintaining or improving the oncologic outcome and cure rates for cancer, compared to the standard of care.

Use of new Taxane based chemotherapy along with Platinum drugs (Cisplatin and Carboplatin) in high dose neoadjuvant setting, coupled with novel minimally invasive Transoral Laser Microsurgery (TLM) and Transoral Robotic Assisted Surgery (TORS), allows potential for improved oncologic outcome as well as avoidance of long term sequalla of high dose radiation therapy to head and neck. These transoral surgical approaches (TLM and TORS) provide improved functional outcome compared with traditional open composite resections and complex reconstructive algorithms for oropharynx. TLM and TORS are currently in clinical use for early (stage T1 and T2 with N0 or N+ve) oropharyngeal cancer.

An area not adequately or at all investigated in treating moderately advanced oropharyngeal cancer is combining neoadjuvant high dose chemo-induction followed by minimally invasive transoral surgery (TLM and TORS) and neck dissection as the definitive treatment.

This approach has the potential for far improved functional outcome by avoiding short and more importantly long term and permanent sequella of radiation therapy in oropharyngeal cancer treatment. This approach is a new paradigm in treatment of oropharyngeal cancer, and can significantly improve the functional outcome of cancer treatment.

Being tested
Cisplatinum, Docetaxel, Carboplatin, Transoral Robotic Assisted Surgery
Keywords
Oropharyngeal cancer, Laryngeal cancer
Medical subject headings
Head and Neck Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinumDrug

    Also called Cisplatin

    Cisplatin 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase

  • DocetaxelDrug

    Also called Taxotere

    Docetaxel 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin AUC=5 every 3 weeks for a maximum of 3 cycles during the induction phase (if subject are unable to tolerate cisplatin)

  • Transoral Robotic Assisted SurgeryProcedure or surgery

    Also called TORS

    TORS will be performed for the patients who responded to the induction treatment (80% reduction)

Study groups in NCT02760667
Study groupRoleWhat they receive
Induction Therapy with 3 cyclesExperimentalCisplatin 75mg/m2 IV and Taxotere 75mg/m2 every 3 weeks for 3 cycles (Induction Chemotherapy) followed by surgical treatment
Receives: Drug: Cisplatinum; Drug: Docetaxel; Drug: Carboplatin; Procedure: Transoral Robotic Assisted Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease specific survival (DSS)

    this parameter is a number will tell the chances of staying free of the head and neck cancer after the study treatment.

    Measured: 3 years

Secondary outcomes (4)

  1. Relapse-free survival

    Considering the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

    Measured: 3 years

  2. Overall survival

    Measure of the length of time from either the date of diagnosis or the start of treatment for a disease that patients diagnosed with the disease are still alive.

    Measured: 3 years

  3. EORTC QLQ-C30

    EORTC QLQ C-30 questionnaire will be administered at baseline (prior to induction chemotherapy), at the end of the 3rd cycle of induction treatment , after surgery, 3 months post-surgery for 1 year and every 6 months thereafter (years 2 and 3)

    Measured: 3 years

  4. EORTC QLQ-H&N35

    EORTC QLQ H\&N35 questionnaire will be administered at baseline (prior to induction chemotherapy), at the end of the 3rd cycle of induction treatment , after surgery, 3 months post-surgery for 1 year and every 6 months thereafter (years 2 and 3)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study startJun 2015
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760667
Sponsor's protocol ID
GWU-MFA Head and Neck Protocol
Status last verified
Jun 2023
First submitted
8 Apr 2016
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatinum, Docetaxel and Carboplatin in people with Head and Neck Cancer, run by George Washington University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease specific survival (DSS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760667.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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