We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reirradiation for Small Inoperable Head and Neck Tumors

This study is currently recruiting participants.
Verified December 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT03164460
First Posted: May 23, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

The goal of this research study is to compare the effectiveness of stereotactic body radioablative therapy (SBRT) to conventional radiation therapy in patients with head and neck cancer who are receiving repeat radiation.

This is an investigational study. Conventional radiation therapy and SBRT are delivered using FDA-approved and commercially available methods. The study doctor can explain how each method of delivering radiation is designed to work.

Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.


Condition Intervention Phase
Head and Neck Cancer Radiation: SBRT Radiation: IMRT/IMPT Behavioral: Questionnaires Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Trial of Stereotactic Onco-Ablative Reirradiation Versus Conventionally Fractionated Conformal Radiotherapy for Patients With Small Inoperable Head and Neck Tumors (SOAR-HN)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Rate of Grade 3 or Higher CTCAE Toxicity Between Stereotactic Ablative Radiotherapy (SBRT) versus Intensity Modulated Radiation Therapy/Intensity Modulated Proton Therapy (IMRT/IMPT) [ Time Frame: 2 years ]
    Toxicities determined per NCI-CTCAE version 4.0.


Secondary Outcome Measures:
  • Local Control Between IMRT/IMPT and SBRT [ Time Frame: 2 years ]
    Local control defined as absence of local failure.

  • Locoregional Failure-Free Survival (LFFS) Between IMRT/IMPT and SBRT [ Time Frame: 2 years ]
    LFFS defined as alive and free of local recurrence or progression.

  • Compare Patient Reported Outcome (PRO) Measures of Symptoms using MD Anderson Symptom Inventory (MDASI) [ Time Frame: 2 years ]

Estimated Enrollment: 100
Actual Study Start Date: May 22, 2017
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Body Radioablative Therapy (SBRT)

Participants receive SBRT every other day for a total of 5 treatments (about 2 weeks).

Questionnaires completed at baseline, before and after radiation treatment, at each visit during radiation therapy, and 2 months after last radiation treatment and then every 3 months after that for up to 2 years.

Radiation: SBRT
Participants receive 45 Gy in 5 fractions prescribed to PTV delivered every other day for an overall treatment time of two weeks.
Behavioral: Questionnaires
Symptom and quality of life questionnaires completed at baseline, before and after radiation treatment, at each visit during radiation therapy, and 2 months after last radiation treatment and then every 3 months after that for up to 2 years.
Other Name: Surveys
Active Comparator: Conventional Radiation Therapy IMRT/IMPT

Participants receive conventional radiation therapy 1 time each weekday (Monday-Friday) for a total of up to 30-35 treatments (about 6-7 weeks).

Questionnaires completed at baseline, before and after radiation treatment, at each visit during radiation therapy, and 2 months after last radiation treatment and then every 3 months after that for up to 2 years.

Radiation: IMRT/IMPT
Participants receive 66 - 70 Gy delivered in 33 - 35 fractions 1 time each weekday (Monday-Friday) for a total of up to 30-35 treatments.
Behavioral: Questionnaires
Symptom and quality of life questionnaires completed at baseline, before and after radiation treatment, at each visit during radiation therapy, and 2 months after last radiation treatment and then every 3 months after that for up to 2 years.
Other Name: Surveys

Detailed Description:

Study Groups:

You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

  • If you are assigned to Group 1, you will receive SBRT.
  • If you are assigned to Group 2, you will receive conventional radiation therapy.

Radiation Therapy:

If you are in Group 1, you will receive SBRT every other day for a total of 5 treatments (about 2 weeks).

If you are in Group 2, you will receive conventional radiation therapy 1 time each weekday (Monday-Friday) for a total of up to 30-35 treatments (about 6-7 weeks).

Length of Study:

Your active participation in this study will be over after the follow-up visits.

Study Visits:

During radiation treatment (1st week of treatment if you are receiving SBRT, 3rd or 4th week if you are receiving conventional radiation therapy) and after receiving radiation treatment, you will complete the same questionnaires that you did at baseline.

At each standard of care visit during your treatment:

  • You will complete the same questionnaires that you did at baseline.
  • If the doctor thinks it is needed, you will have an MRI and either a CT or PET-CT scan at the Center for Advanced Biomedical Imaging to help with radiation treatment planning.

Follow-Up Visits:

About 2 months after your last radiation treatment and then every 3 months after that for up to 2 years:

  • You will complete the same questionnaires that you did at baseline.
  • If the doctor thinks it is needed, you will have a CT and PET-CT scan to check the status of the disease.

Additional Information:

  • Researchers will collect information from your medical record before, during, and for up to 5 years after radiation therapy for this study. This information will be related to your personal medical history, diagnosis, and the treatment you received or are scheduled to receive for head and neck cancer.
  • The questionnaires may be completed in person, by phone, or on REDcap (a secure, web-based program used to collect data for research studies).
  • A member of the study staff may contact you by phone, mail, or email to remind you to complete the questionnaires.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer
  2. Not eligible for surgery for recurrence or poor surgical candidate
  3. Gross disease apparent on imaging (magnetic resonance imaging (MRI) or computed tomography (CT))
  4. 1-3 sites of recurrence (<60 cc per site, total volume <100 cc)
  5. Age >/= 18 years
  6. Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
  7. Negative pregnancy test for women of child bearing potential

Exclusion Criteria:

  1. Patients who are pregnant or breast feeding
  2. Clinically significant uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal or hematologic disease but not limited to: *a) Symptomatic congestive heart failure, unstable angina, or cardiac dysrhythmia not controlled by pacer device *b) No myocardial infarction within 3 months of registration
  3. Widely metastatic disease (oligometastatic disease acceptable)
  4. Patients with a pacemaker
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03164460


Contacts
Contact: Jack Phan, MD, PHD 713-563-2300 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Jack Phan, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03164460     History of Changes
Other Study ID Numbers: 2016-1065
First Submitted: May 22, 2017
First Posted: May 23, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by M.D. Anderson Cancer Center:
Head and Neck Cancer
Stereotactic ablative radiotherapy
SBRT
Intensity modulated radiation therapy
IMRT
Intensity modulated proton therapy
IMPT
Questionnaires
Surveys

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms