Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck

Sponsor
David A. Clump, MD, PhD (Other)
Overall Status
Completed
CT.gov ID
NCT01104922
Collaborator
(none)
48
1
1
127
0.4

Study Details

Study Description

Brief Summary

This trial examines survival and toxicity in previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the above therapy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Squamous cell carcinoma of the head and neck is the sixth most common malignancy worldwide with approximately 500,000 cases worldwide yearly. There were an estimated 39,250 new cases and 11,000 deaths in the United States in 2005 (Jemal 2005, Spitz MR). Despite major improvements in the treatment of SCCHN in recent years which include the introduction of concurrent chemoradiotherapy as an effective primary or postoperative therapy, the five-year survival rate for patients with SCCHN in the United States and other developed countries remains poor as nearly 50-60% of these patients will die as a direct result of recurrent locoregional disease. This study aims to determine the 1-year progression-free survival (PFS) of previously irradiated patients with squamous cell carcinoma of the head and neck (SCCHN) treated with radiosurgery and cetuximab and to evaluate the acute and late toxicities associated with the therapy.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
Actual Study Start Date :
Dec 26, 2007
Actual Primary Completion Date :
May 21, 2014
Actual Study Completion Date :
Jul 26, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cetuximab and stereotactic radiosurgery

Drug: Cetuximab
Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery.
Other Names:
  • Erbitux
  • Device: Stereotactic radiosurgery
    Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)

    Outcome Measures

    Primary Outcome Measures

    1. 1-year Local Progression-free Survival (PFS) [At 1-year]

      Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.

    2. 1-year Locoregional Progression-free Survival (PFS) [At 1-year]

      Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.

    3. 1-year Distant Progression-free Survival (PFS) [At 1-year]

      Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.

    Secondary Outcome Measures

    1. 1-year Progression-free Survival (PFS) [At 1-year]

      Progression was defined as greater than 20% increase in the sum of the longest diameters of target lesions, per Response Evaluation Criteria in Solid Tumors (RECIST v1.0), taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.

    2. Overall Survival (OS) [Up to 2 years]

      Number of months patients remaining alive after study treatment.

    3. Overall Response (OR) [Up to 2 years]

      Response by number and percentage of patients assessed by subjective interpretation of the first PET-CT. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.

    4. Changes in Tumor Glucose Metabolism [Up to 24 months / post therapy]

      Glucose metabolism was assessed by FDG PET. FDG uptake reflects the tissue glucose metabolism and is usually high in high-grade tumors and relatively low in low-grade tumors.

    5. Changes in Tumor Hypoxia. [Up to 24 months; before and after treatment]

      Changes in tumor hypoxia (tumor cells deprived of oxygen) as a result of Stereotactic radiosurgery (SRS) through assessment by pre-and post-treatment fluorodeoxyglucose (FDG)- and fluoromisonidazole (FMISO)-PET.

    6. Quality of Life (QoL) [Baseline, 6-8 weeks post-treatment; up to 16 months]

      Percentage of patients that reported stable and/or improved of quality of life after SBRT as indicated by a quantitative increase or maintenance in overall score. Quality of Life was assessed by longitudinal collection of the University of Washington Quality of Life Registry (UW-QoL-R) survey data, both pre- and post-SBRT. Patients completed the previously validated UW-QoL-R survey at enrollment and again after SBRT. UW-QoL-R measures patient reported QoL in 12 head and neck-specific and 3 global health domains, using a single Likert-scale question with an assigned score of 0 to 100 with 100 representing normal function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically proven recurrent squamous cell carcinoma of the head and neck (SCCHN), who has received prior radiotherapy with or without chemotherapy. New primary is allowed if location is in a previously irradiated field. Biopsy is recommended for each recurrence; but is not mandated per study. This will be at the discretion of the principal investigator.

    • Prior radiation dose of at least 60 Gy.

    • Disease confined to locoregional site and can be encompassed in a stereotactic radiosurgery "portal"

    • Tumor must be deemed to be inoperable or unresectable either by clinical or radiographic criteria. These criteria include encasement of great vessels, vertebral invasion or undue peri-operative risk.

    • Prior surgery for recurrent or new SCCHN is allowed in previously irradiated patients. A minimum of 4 weeks should elapse between any surgery and treatment on study. However, high risk pathologic features should be present, such as positive margins, positive lymphadenopathy, perineural or angiolymphatic invasion. Measurable disease must be present for assessment of response.

    • Karnofsky performance status > 60 (ECOG 0-2)

    • Prior treatment with an EGFR Inhibitor is allowed if it was a part of prior curative therapy and was completed at least 30 days prior to commencement of study therapy

    • Any number of prior chemotherapy regimens are allowed

    • Measurable disease on imaging studies (MRI, CT, PET-CT or physical exam)

    • Age > 18

    • Estimated life expectancy > 12 weeks

    • No prior radiation therapy or chemotherapy within 1 month of study enrollment

    • No prior chemotherapy or targeted therapy within the previous 4 weeks

    • ANC > 1000, PLT>75,000, Serum creatinine<2.5 mg/dL, Bilirubin <1.5 x upper limits of normal (ULN)

    • Diabetes must be controlled prior to PET-CT scanning (blood glucose <200 mg/dL)

    • Ability to provide written informed consent

    Exclusion Criteria:
    • Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT) or other staging studies

    • History of any cancer other than SCCHN (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years.

    • Patients in their reproductive age group should use an effective method of birth control. Patients who are breast-feeding, or have a positive pregnancy test will be excluded from the study

    • Any co-morbidity or condition of sufficient severity to limit full compliance with the protocol per assessment by the investigator

    • Concurrent serious infection

    • History of known hypersensitivity to cetuximab or similar agents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15232

    Sponsors and Collaborators

    • David A. Clump, MD, PhD

    Investigators

    • Principal Investigator: David A Clump, MD, University of Pittsburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David A. Clump, MD, PhD, Associate Professor of Medicine, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT01104922
    Other Study ID Numbers:
    • UPCI 06-093
    First Posted:
    Apr 16, 2010
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by David A. Clump, MD, PhD, Associate Professor of Medicine, University of Pittsburgh
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Period Title: Overall Study
    STARTED 48
    COMPLETED 48
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Overall Participants 48
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    63
    Sex: Female, Male (Count of Participants)
    Female
    18
    37.5%
    Male
    30
    62.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    0
    0%
    White
    48
    100%
    More than one race
    0
    0%
    Unknown or Not Reported
    0
    0%
    Prior surgery (percentage of participants) [Number]
    Number [percentage of participants]
    67
    139.6%
    Prior chemotherapy (percentage of participants) [Number]
    Number [percentage of participants]
    65
    135.4%
    Received prior epidermal growth factor receptor (EGFR) (percentage of participants) [Number]
    Number [percentage of participants]
    23
    47.9%
    Zubrod performance status (Count of Participants)
    Score = 0
    22
    45.8%
    Score = 1
    23
    47.9%
    Score = 2
    3
    6.3%

    Outcome Measures

    1. Primary Outcome
    Title 1-year Local Progression-free Survival (PFS)
    Description Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
    Time Frame At 1-year

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy and were evaluable for response to treatment.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 48
    Number (95% Confidence Interval) [percentage of participants]
    60
    125%
    2. Primary Outcome
    Title 1-year Locoregional Progression-free Survival (PFS)
    Description Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
    Time Frame At 1-year

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy and were evaluable for response to treatment.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 48
    Number (95% Confidence Interval) [percentage of participants]
    37
    77.1%
    3. Primary Outcome
    Title 1-year Distant Progression-free Survival (PFS)
    Description Progression (response as assessed by subjective interpretation of the first PET-CT) per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) was defined as greater than 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
    Time Frame At 1-year

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy and were evaluable for response to treatment.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 48
    Number (95% Confidence Interval) [percentage of participants]
    77
    160.4%
    4. Secondary Outcome
    Title 1-year Progression-free Survival (PFS)
    Description Progression was defined as greater than 20% increase in the sum of the longest diameters of target lesions, per Response Evaluation Criteria in Solid Tumors (RECIST v1.0), taking as reference the smallest sum and longest diameter recorded since the baseline measurements or the appearance of 1 or more new lesion(s). If the measurable disease was restricted to a solitary lesion, the protocol specified that neoplastic nature should be confirmed by cytology and histology.
    Time Frame At 1-year

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy and were evaluable for response to treatment.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 48
    Number (95% Confidence Interval) [percentage of participants]
    33
    68.8%
    5. Secondary Outcome
    Title Overall Survival (OS)
    Description Number of months patients remaining alive after study treatment.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 48
    Median (95% Confidence Interval) [months]
    10
    6. Secondary Outcome
    Title Overall Response (OR)
    Description Response by number and percentage of patients assessed by subjective interpretation of the first PET-CT. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response(CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy and were evaluable for response to treatment.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 48
    Complete response
    9
    18.8%
    Partial Response
    13
    27.1%
    Stable disease
    5
    10.4%
    Disease progression
    17
    35.4%
    7. Secondary Outcome
    Title Changes in Tumor Glucose Metabolism
    Description Glucose metabolism was assessed by FDG PET. FDG uptake reflects the tissue glucose metabolism and is usually high in high-grade tumors and relatively low in low-grade tumors.
    Time Frame Up to 24 months / post therapy

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy and were evaluable for response and by FDG PET.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 44
    Complete Response (CR)
    9
    18.8%
    Partial Response (PR)
    13
    27.1%
    Stable Disease (SD)
    5
    10.4%
    Progressive Disease (PD)
    17
    35.4%
    8. Secondary Outcome
    Title Changes in Tumor Hypoxia.
    Description Changes in tumor hypoxia (tumor cells deprived of oxygen) as a result of Stereotactic radiosurgery (SRS) through assessment by pre-and post-treatment fluorodeoxyglucose (FDG)- and fluoromisonidazole (FMISO)-PET.
    Time Frame Up to 24 months; before and after treatment

    Outcome Measure Data

    Analysis Population Description
    At the time of this study, PMISO could not be readily obtained due to its relatively short half-life and unforeseen inability to procure this radioisotope locally. Thus, to prevent delay in treating aggressive cancer, F-MISO scans were not performed.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 0
    9. Secondary Outcome
    Title Quality of Life (QoL)
    Description Percentage of patients that reported stable and/or improved of quality of life after SBRT as indicated by a quantitative increase or maintenance in overall score. Quality of Life was assessed by longitudinal collection of the University of Washington Quality of Life Registry (UW-QoL-R) survey data, both pre- and post-SBRT. Patients completed the previously validated UW-QoL-R survey at enrollment and again after SBRT. UW-QoL-R measures patient reported QoL in 12 head and neck-specific and 3 global health domains, using a single Likert-scale question with an assigned score of 0 to 100 with 100 representing normal function.
    Time Frame Baseline, 6-8 weeks post-treatment; up to 16 months

    Outcome Measure Data

    Analysis Population Description
    Patients that received study therapy and were able to complete Quality of Life assessments, who reported stable or improved quality of life.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    Measure Participants 28
    Number [percentage of participants]
    62
    129.2%

    Adverse Events

    Time Frame Adverse events were assessed through study completion, up to 2 years.
    Adverse Event Reporting Description Adverse Events and Serious Adverse Events determined using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 Adverse Events were Grade 1 and Grade2 toxicities; Serious Adverse Events were Grade 3 and Grade 4 toxicities. All-Cause Mortality: At last follow-up, 69% died of disease, 4% died with disease, 15% died without progression, 10% were alive without progression, and 2% were alive with progression; 88% deceased at time of final analysis.
    Arm/Group Title Cetuximab and Stereotactic Radiosurgery
    Arm/Group Description Cetuximab: Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Stereotactic radiosurgery: Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
    All Cause Mortality
    Cetuximab and Stereotactic Radiosurgery
    Affected / at Risk (%) # Events
    Total 42/48 (87.5%)
    Serious Adverse Events
    Cetuximab and Stereotactic Radiosurgery
    Affected / at Risk (%) # Events
    Total 3/48 (6.3%)
    Gastrointestinal disorders
    Dysphagia 1/48 (2.1%)
    Skin and subcutaneous tissue disorders
    Rash (erbiutx) 1/48 (2.1%)
    Hyperpigmentation 1/48 (2.1%)
    Other (Not Including Serious) Adverse Events
    Cetuximab and Stereotactic Radiosurgery
    Affected / at Risk (%) # Events
    Total 43/48 (89.6%)
    Gastrointestinal disorders
    Dry Mouth (Xerostomia) 8/48 (16.7%)
    Dysgeusia (Taste Alteration 4/48 (8.3%)
    Mucositis 26/48 (54.2%)
    Dysphagia 9/48 (18.8%)
    Odynphagia (Painful swallowing) 8/48 (16.7%)
    Dysphonia (difficulty speaking) 1/48 (2.1%)
    Nausea 2/48 (4.2%)
    Vomiting 5/48 (10.4%)
    Stomatitis 1/48 (2.1%)
    General disorders
    Pain 5/48 (10.4%)
    Fatigue 5/48 (10.4%)
    Musculoskeletal and connective tissue disorders
    Osteonecrosis 1/48 (2.1%)
    Respiratory, thoracic and mediastinal disorders
    Voice Changes (hoarsenss) 2/48 (4.2%)
    Skin and subcutaneous tissue disorders
    Rash (erbiutx) 15/48 (31.3%)
    Hyperpigmentation 6/48 (12.5%)
    Fibrosis 1/48 (2.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Barbara Stadterman, Regulatory Supervisor; ClinicalTrials.gov Admin
    Organization UPMC Hillman Cancer Center
    Phone 412-647-5554
    Email stadtermanbm@upmc.edu
    Responsible Party:
    David A. Clump, MD, PhD, Associate Professor of Medicine, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT01104922
    Other Study ID Numbers:
    • UPCI 06-093
    First Posted:
    Apr 16, 2010
    Last Update Posted:
    Feb 14, 2022
    Last Verified:
    Feb 1, 2022