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

M.D. Anderson Cancer Center

Status and phase: Suspended; Phase 2

Conditions: Recurrent Head and Neck Carcinoma

Treatments: Radiation: Proton Radiation; Radiation: Stereotactic Body Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03164460

2016-1065 (Other Identifier)

NCI-2018-01190 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Group I (SBRT)

Experimental group

Description:

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

Treatment:

Radiation: Stereotactic Body Radiation Therapy

Group II (IMRT/IMPT)

Experimental group

Description:

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

Treatment:

Radiation: Intensity-Modulated Radiation Therapy

Radiation: Proton Radiation