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Reirradiation for Small Inoperable Head and Neck Tumors

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ClinicalTrials.gov Identifier: NCT03164460
Recruitment Status : Recruiting
First Posted : May 23, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: SBRT Radiation: IMRT/IMPT Behavioral: Questionnaires Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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)
Actual Study Start Date : May 22, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. Local Control Between IMRT/IMPT and SBRT [ Time Frame: 2 years ]
    Local control defined as absence of local failure.

  2. 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.

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03164460     History of Changes
Other Study ID Numbers: 2016-1065
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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