Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer

NCT ID: NCT03164460

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2027-05-31

Brief Summary

This phase II trial studies how well stereotactic body radiation therapy or intensity modulated radiation/proton therapy works in treating patients with head and neck cancer that has come back. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Intensity modulated radiation/proton therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. It is not yet known whether stereotactic body radiation therapy or intensity modulated radiation/proton therapy may work better in treating patients with head and neck cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the 2-year rate of Common Terminology Criteria for Adverse Events (CTCAE)-4.0 grade 3 or higher toxicity at 2 years between the two treatment arms.

SECONDARY OBJECTIVES:

I. To compare the 2-year locoregional failure free survival (LFFS) in patients being treated with reirradiation with either stereotactic ablative radiotherapy (SBRT) versus intensity modulated radiation therapy/intensity modulated proton therapy (IMRT/IMPT).

II. To determine if there is any difference in local control, progression-free survival, and overall survival between the two arms.

III. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE)-4.0 and Performance Status Scale-HN (Head and Neck).

IV. To compare patient reported outcome (PRO) measures of symptoms using MD Anderson Symptom Inventory (MDASI), MD Anderson Dysphagia Inventory (MDADI), Functional Assessment of Cancer Therapy (FACT)-HN, ACT-HN Symptom Index (FACT-HNSI), MD Anderson Symptom Inventory-Brain Tumor (MDASI-BT), for skull base only, Anterior Skull BASE Questionnaire (ASBQ), for skull base only, Brief Fatigue Inventory (BFI), Telephone Interview for Cognitive Status (TICS), Performance Status Scale For Head and Neck Cancer Patients (PSS-HN), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem version (V)2.0 (WPAI:SHP), and University of Michigan Xerostomia-Related Quality of Life Scale, Xerostomia and Health Questionnaire (European Quality of Life Five Dimension Three Level [EQ-5D-3L]).

V. Quality-Adjusted-Life-Years (QALY) comparison between IMPT and IMRT. VI. Compare cost-benefit economic analysis of treatment. VII. Perform dosimetric analysis and compare correlates of critical structures.

EXPLORATORY OBJECTIVES:

I. To assess potential differences between patients on study and patients who were considered eligible for randomized, were randomized to a treatment arm, but may have dropped out of the study for other reasons after being randomized to; or were denied insurance coverage for the treatment arm she/he was randomized.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients undergo SBRT every other day for a total of 5 treatments.

GROUP II: Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.

After completion of study treatment, patients are followed up at 2-3 months, every 3 months for 1 year, and then every 3-4 months for up to 2 years.

Conditions

Recurrent Head and Neck Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I (SBRT)

Patients undergo SBRT every other day for a total of 5 treatments.

Group Type: EXPERIMENTAL

Stereotactic Body Radiation Therapy

Intervention Type: RADIATION

Undergo SBRT

Group II (IMRT/IMPT)

Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.

Group Type: EXPERIMENTAL

Intensity-Modulated Radiation Therapy

Intervention Type: RADIATION

Undergo IMRT/IMPT

Proton Radiation

Intervention Type: RADIATION

Undergo IMRT/IMPT

Interventions

Intensity-Modulated Radiation Therapy

Undergo IMRT/IMPT

Intervention Type: RADIATION

Proton Radiation

Undergo IMRT/IMPT

Intervention Type: RADIATION

Stereotactic Body Radiation Therapy

Undergo SBRT

Intervention Type: RADIATION

Other Intervention Names

IMRT; Intensity Modulated RT; Intensity-Modulated Radiotherapy; Radiation, Charged Particles-Protons; SABR; SBRT; Stereotactic Ablative Body Radiation Therapy

Eligibility Criteria

Inclusion Criteria

• 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
• Not eligible for surgery for recurrence or poor surgical candidate
• Gross disease apparent on imaging (magnetic resonance imaging [MRI] or computed tomography [CT])
• 1-3 sites of recurrence (< 60 cc per site, total volume < 100 cc)
• Eastern Cooperative Oncology Group (ECOG) = 0, 1, or 2
• Negative pregnancy test for women of child bearing potential

Exclusion Criteria

• Patients who are pregnant or breast feeding
• 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
• Widely metastatic disease (oligometastatic disease acceptable)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack Phan

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2018-01190

Identifier Type: REGISTRY

Identifier Source: secondary_id

2016-1065

Identifier Type: OTHER

Identifier Source: secondary_id

2016-1065

Identifier Type: -

Identifier Source: org_study_id