Hypofractionated Reduced-Volume Chemoradiation for T1/2N0-2 SCC Head and Neck

January 28, 2021 updated by: University of Texas Southwestern Medical Center

A Phase I Study of Reduced-Volume Hypofractionated, PET-directed Intensity Modulated Radiotherapy Concurrent With Weekly Cisplatin Chemotherapy for T1/2N0-2 Squamous Cell Carcinoma of the Head and Neck

Primary Objectives:

To determine whether patients with T1/2N0-2 Squamous Cell Carcinoma of the oropharynx, hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks using reduced volume IMRT

Secondary Objectives:

To describe the adverse events associated with hypofractionated, reduced volume cisplatin chemoradiation.

To estimate response rates and progression-free survival rates of hypofractionated, reduced volume cisplatin chemoradiation.

To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation.

If patients can safely be treated in three weeks rather than six weeks, such a schedule would provide a much more convenient alternative for patients and result in a significant reduction in the health care resources currently expended on cure of these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Head and neck squamous cell carcinomas (HNSCC) are frequently occurring tumors with more than 500,000 new cases worldwide and 45,000 in the USA yearly . Most patients present with local-regionally advanced diseases. Chemotherapy given concurrently with radiation is an integrated treatment component in the management of these patients. Concurrent chemoradiation can be given in unresectable diseases, in organ preservation to avoid surgery and preserve functions, and in high risk patients after surgery . Randomized clinical trials and meta-analyses have shown that concurrent chemoradiation are superior to radiation alone in these settings.

One way of reducing overall treatment time and toxicity is to reduce the number of fractions by increasing the daily radiotherapy dose. The consequence of increased daily dose is both an increase in acute side effects as well as an increase in late toxicity. A widely accepted model of these radiobiologic effects over the range of typical 2-4 Gy daily fractions is the alpha-beta model that distinguishes acute responses and late responses based on a linear-quadratic fitting of extrapolated clonogenic survival curves. A time factor can be incorporated to account for the effect of repopulation. Equivalent biologically effective dose schedules using a reduced number of fractions may be calculated for any conventionally fractionated course. Because 70Gy/35/6 weeks with chemoradiation has been demonstrated to be tolerable, and because 66Gy/30/6 weeks has been shown with IMRT to produce 90% control for T1/2 oropharyngeal primary tumors, we will take the biological equivalent of 66Gy/33 fractions over six weeks as the biologic equivalent standard we wish to maintain in hypofractionated courses of radiation. Because 54Gy/30 over six weeks is a well-known elective radiation dose schedule producing 95% control of occult nodal disease, we will take this as the biologically equivalent standard we wish to maintain in our hypofractionated schedules.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas at Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. T1/2N0-2M0 SCC of the oropharynx, hypopharynx or larynx
  2. Age ≥ 18 years.
  3. Performance status ECOG 0-1
  4. Adequate organ and marrow function as determined by medical oncology evaluation.
  5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

6. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  • Has not undergone a hysterectomy or bilateral oophorectomy; or

  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).

    7 Ability to understand and the willingness to sign a written informed consent.

    8. Creatinine clearance (CC) ≥ 50 ml/min within 4 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)] (CCr female = 0.85 x (CrCl male)).

    9. History/physical examination within 4 weeks prior to registration, including assessment of weight and weight loss in past 6 months.

    10. Medical oncology examination to evaluate medical contraindications prior to start chemotherapy 11 Dental evaluation with management prior to start of radiation 12 Nutrition evaluation with consideration of percutaneous endoscopic gastrostomy (PEG) tube placement 13 No distant metastasis by PET/CT

Exclusion Criteria:

  1. T3/4 or N3
  2. T1N0 disease
  3. Metastatic disease
  4. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  5. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  6. Primary site of tumor of oral cavity, nasopharynx, sinuses, or salivary glands
  7. Neck adenopathy that involves the overlying skin.
  8. Initial surgical treatment including tonsillectomy or neck dissection, but excluding diagnostic biopsy of the primary site or nodal sampling of neck disease
  9. Pre-existing grade > 2 peripheral sensory neuropathy
  10. Subjects may not be receiving any other investigational agents.
  11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  12. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: chemoradiation
Hypofractionated, PET-directed, Intensity Modulated Radiotherapy Concurrent with Weekly Cisplatin Chemotherapy
Radiation: Intensity Modulated Radiotherapy
Patients treated five fractions per week with radiotherapy dose per fraction and cisplatin dose increased according to the treatment table
Other Names:
  • Hypofractionated,

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment completion
Time Frame: 3 weeks
To determine whether patients with locally advanced SCC of the oropharynx, hypopharynx or larynx can tolerate treatment with cisplatin chemoradiation in three weeks using reduced volume IMRT.
3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: 90 days
To describe the adverse events associated with hypofractionated, reduced volume cisplatin chemoradiation.
90 days
progression-free survival rates
Time Frame: 5 years
To estimate response rates and progression-free survival rates of hypofractionated, reduced volume cisplatin chemoradiation.
5 years
Health-related quality of life
Time Frame: 2 years
To determine HRQOL following hypofractionated, reduced volume cisplatin chemoradiation.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lucien Nedzi, MD, UTSW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU 112013-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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