Re-irradiation With Fractionated Stereotactic Radiosurgery Plus Cetuximab in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
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
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:
Device: Stereotactic radiosurgery
Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy)
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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-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.
- Overall Survival (OS) [Up to 2 years]
Number of months patients remaining alive after study treatment.
- 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.
- 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.
- 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.
- 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
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.- UPCI 06-093
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
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%
|
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%
|
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%
|
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%
|
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
|
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%
|
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%
|
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 |
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
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 |
stadtermanbm@upmc.edu |
- UPCI 06-093