Trial Outcomes & Findings for A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma (NCT NCT02805179)

NCT ID: NCT02805179

Last Updated: 2021-04-15

Results Overview

Percentage of patients alive at 12 months after completion of chemoradiation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: 12 months after completion of chemoradiation
• Results posted on: 2021-04-15

Participant Flow

Participant milestones

Measure	All Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Overall Study STARTED	26
Overall Study Eligible Patients That Started Dose-intensified Chemo-radiation	23
Overall Study Subset of Participants, Boosted to Both High B-value Diffusion and Perfusion	13
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma

Baseline characteristics by cohort

Measure	High Dose Chemoradiation n=26 Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after completion of chemoradiation

Population: all eligible patients who completed dose-intensified chemo-radiation

Percentage of patients alive at 12 months after completion of chemoradiation

Outcome measures

Measure	High Dose Chemoradiation n=23 Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Overall Survival at 12 Months all eligible patients who completed dose-intensified chemo-radiation	74 percentage of participants Interval 56.0 to 92.0
Overall Survival at 12 Months only patients who were boosted to both diffusion and perfusion	92 percentage of participants Interval 78.0 to 100.0

PRIMARY outcome

Timeframe: Median follow-up time was 26 months

Population: all eligible patients who completed dose-intensified chemo-radiation

Median overall survival in months

Outcome measures

Measure	High Dose Chemoradiation n=23 Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Median Overall Survival all eligible patients who completed dose-intensified chemo-radiation	20 months Interval 14.0 to 29.0
Median Overall Survival only patients who were boosted to both diffusion and perfusion	20 months Interval 18.0 to Upper limit was not reached due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: Median follow-up time was 26 months

Population: all eligible patients who completed dose-intensified chemo-radiation

From start of RT until disease progression or death, or until date of last imaging follow-up, estimated using Kaplan-Meier. Progression is defined by any of the following: >= 25% increase in sum of the products of perpendicular diameters of enhancing lesions (compared with baseline if no decrease) on stable or increasing doses of corticosteroids; a significant increase in T2/FLAIR non-enhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not due to comorbid events; appearance of any new lesions; clear progression of non-measurable lesions; or definite clinical deterioration not attributable to causes other than tumor, or to decrease in corticosteroid dose. When pathologic confirmation was unavailable, progression was defined as worsening enhancement based on imaging with or without adjunctive advanced imaging including perfusion MRI or magnetic resonance spectroscopy, when clinically indicated.

Outcome measures

Measure	High Dose Chemoradiation n=23 Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Median Progression-free Survival all eligible patients who completed dose-intensified chemo-radiation	10 months Interval 7.0 to 17.0
Median Progression-free Survival only patients who were boosted to both diffusion and perfusion	12 months Interval 10.0 to 17.0

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: All enrolled patients had available imaging were included in this analysis

Tumor volume will be measured by diffusion MRI and perfusion MRI before treatment start and at mid-treatment.

Outcome measures

Measure

High Dose Chemoradiation n=26 Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.

Median Change in Tumor Volume From Baseline to Mid-radiation Treatment (Week 4)

-2.9 cubic centimeters Interval -5.3 to -1.8

SECONDARY outcome

Timeframe: Baseline to 1 and 7 months

Population: all eligible patients who completed dose-intensified chemo-radiation

Percentage of patients that experienced deterioration in QOL per the European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.

Outcome measures

Measure	High Dose Chemoradiation n=23 Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Percentage of Patients That Experienced Deterioration in Quality of Life (QOL) at 1 month	26 percentage of participants
Percentage of Patients That Experienced Deterioration in Quality of Life (QOL) at 7 months	33 percentage of participants

SECONDARY outcome

Timeframe: Median 26 months

Population: all eligible patients who completed dose-intensified chemo-radiation

Failures will be classified as central or in-field, marginal or distant based on previously published criteria. 1) "central," in which 95% or more of the recurrent tumor volume (Vrecur) was within D95, the region treated to high dose (95% of the prescription dose); 2) "in-field," in which 80% or more of Vrecur was within the D95 isodose surface; 3) "marginal," when between 20 and 80% of Vrecur was inside the D95 surface; 4) "outside," in which less than 20% of Vrecur was inside the D95 surface.

Outcome measures

Measure	High Dose Chemoradiation n=23 Participants Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Percentage of Patients With Failure; Central or In-field vs. Marginal or Distant central or in-field	31 percentage of participants
Percentage of Patients With Failure; Central or In-field vs. Marginal or Distant non-central/non-in-field (marginal or distant)	69 percentage of participants

Adverse Events

All Enrolled Patients

Serious events: 8 serious events

Other events: 25 other events

Deaths: 21 deaths

Serious adverse events

Measure	All Enrolled Patients n=26 participants at risk Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Gastrointestinal disorders Nausea	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Localized edema	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Infections and infestations Urinary tract infection	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Infections and infestations Wound infection	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Headache	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Nervous system disorders - Other	7.7% 2/26 • Number of events 3 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Psychiatric disorders Confusion	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Vascular disorders Thromboembolic event	7.7% 2/26 • Number of events 3 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.

Other adverse events

Measure	All Enrolled Patients n=26 participants at risk Patients will receive high dose radiation based in part on advanced imaging, and concurrent temozolomide. Four weeks after the completion of chemoradiation, patients will receive adjuvant temozolomide. High Dose Radiation: Radiation will be delivered once daily for a total of 30 fractions, five days per week. Temozolomide: Patients will receive concurrent temozolomide (75 mg/m\^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m\^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
Blood and lymphatic system disorders Anemia	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Cardiac disorders Ventricular tachycardia	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Ear and labyrinth disorders Hearing impaired	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Ear and labyrinth disorders Vertigo	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Eye disorders Blurred vision	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Eye disorders Eye disorders - Other	11.5% 3/26 • Number of events 3 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Abdominal pain	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Constipation	34.6% 9/26 • Number of events 9 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Diarrhea	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Dry mouth	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Dyspepsia	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Gastroesophageal reflux disease	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Nausea	42.3% 11/26 • Number of events 15 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Salivary duct inflammation	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Gastrointestinal disorders Stomach pain	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Edema face	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Edema limbs	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Fatigue	76.9% 20/26 • Number of events 26 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Gait disturbance	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders General disorders and administration site conditions - Other	19.2% 5/26 • Number of events 7 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Localized edema	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Non-cardiac chest pain	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
General disorders Pain	19.2% 5/26 • Number of events 6 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Immune system disorders Allergic reaction	11.5% 3/26 • Number of events 4 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Infections and infestations Infections and infestations - Other	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Infections and infestations Papulopustular rash	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Infections and infestations Sinusitis	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Injury, poisoning and procedural complications Dermatitis radiation	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Injury, poisoning and procedural complications Fall	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Injury, poisoning and procedural complications Wound complication	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Investigations Creatinine increased	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Investigations Investigations - Other	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Investigations Lymphocyte count decreased	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Investigations Platelet count decreased	26.9% 7/26 • Number of events 16 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Investigations Weight gain	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Investigations Weight loss	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Metabolism and nutrition disorders Anorexia	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Metabolism and nutrition disorders Hyponatremia	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Back pain	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Muscle weakness right-sided	15.4% 4/26 • Number of events 5 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	11.5% 3/26 • Number of events 3 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Myalgia	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Neck pain	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Musculoskeletal and connective tissue disorders Pain in extremity	11.5% 3/26 • Number of events 3 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Ataxia	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Concentration impairment	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Dizziness	26.9% 7/26 • Number of events 7 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Dysarthria	11.5% 3/26 • Number of events 4 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Dysgeusia	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Dysphasia	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Headache	30.8% 8/26 • Number of events 8 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Hypersomnia	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Nervous system disorders - Other	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Paresthesia	15.4% 4/26 • Number of events 6 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Seizure	11.5% 3/26 • Number of events 4 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Somnolence	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Nervous system disorders Tremor	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Psychiatric disorders Anxiety	11.5% 3/26 • Number of events 3 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Psychiatric disorders Confusion	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Psychiatric disorders Depression	15.4% 4/26 • Number of events 4 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Psychiatric disorders Insomnia	26.9% 7/26 • Number of events 9 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Psychiatric disorders Psychiatric disorders - Other	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Renal and urinary disorders Cystitis noninfective	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Renal and urinary disorders Renal and urinary disorders - Other	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Renal and urinary disorders Urinary frequency	7.7% 2/26 • Number of events 2 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Respiratory, thoracic and mediastinal disorders Apnea	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Respiratory, thoracic and mediastinal disorders Cough	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Skin and subcutaneous tissue disorders Alopecia	23.1% 6/26 • Number of events 6 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Skin and subcutaneous tissue disorders Erythema multiforme	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Skin and subcutaneous tissue disorders Pruritus	11.5% 3/26 • Number of events 3 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Skin and subcutaneous tissue disorders Urticaria	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Vascular disorders Flushing	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Vascular disorders Hypertension	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.
Vascular disorders Lymphedema	3.8% 1/26 • Number of events 1 • Time frame for toxicity was from the time of the initial intervention through 30 days following the completion of radiation therapy. Subacute and late neurologic toxicity beyond 30 days was assessed every 2 to 3 months, and all patients were monitored for late neurologic toxicity until last follow-up or death. The median follow-up time was 26 months.

Additional Information

Michelle Kim, MD

University of Michigan

Phone: 734-936-4300

Email: michekim@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place