Trial Outcomes & Findings for A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer (NCT NCT02492867)

Last Updated: 2024-09-03

Results Overview

To determine the feasibility of the proposed adaptive treatment strategy, we will look at the number of patients for whom treatment is feasible. Treatment is feasible if we are able to deliver the full treatment, using the image based spatial replanning and complete the cytokine assays in a short enough timeframe to adapt radiation dose.

Recruitment status

COMPLETED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

6 weeks (30 treatments, 5 days per week)

Results posted on

2024-09-03

Participant Flow

Two patients were enrolled but were never treated, 5 patients started treatment but did not complete

Participant milestones

Participant milestones
Measure	Response-driven Adaptive RT Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Overall Study STARTED	47
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Response-driven Adaptive RT Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Overall Study Alternate therapy	1
Overall Study Withdrawal by Subject	2
Overall Study Disease progression after treatment started	1
Overall Study Death	1

Baseline Characteristics

A Pilot Study of Response-Driven Adaptive Radiation Therapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Response-driven Adaptive RT n=47 Participants Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants
Age, Continuous	66.4 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks (30 treatments, 5 days per week)

Outcome measures

Outcome measures
Measure	Response-driven Adaptive RT n=47 Participants Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
The Number of Patients for Whom Treatment is Feasible.	40 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Lung toxicity will be graded using CTCAE v4.0. These will include, but not be limited to: cough, dyspnea, pneumonitis, radiation pneumonitis, and radiographic or clinical pulmonary fibrosis.

Outcome measures

Outcome measures
Measure	Response-driven Adaptive RT n=47 Participants Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
The Number of Patients That Experience Grade 2 or Greater Lung Toxicity cough	8 Participants
The Number of Patients That Experience Grade 2 or Greater Lung Toxicity pneumonitis	1 Participants
The Number of Patients That Experience Grade 2 or Greater Lung Toxicity Dyspnea	6 Participants
The Number of Patients That Experience Grade 2 or Greater Lung Toxicity radiation pneumonitis	0 Participants
The Number of Patients That Experience Grade 2 or Greater Lung Toxicity Pulmonary fibrosis	1 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Esophageal toxicities will be graded using CTCAE v4.0. These will include, but not be limited to esophagitis.

Outcome measures

Outcome measures
Measure	Response-driven Adaptive RT n=47 Participants Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
The Number of Patients That Experience Grade 2 or Greater Esophageal Toxicity Esophageal hemorrhage	1 Participants
The Number of Patients That Experience Grade 2 or Greater Esophageal Toxicity Esophageal Pain	9 Participants
The Number of Patients That Experience Grade 2 or Greater Esophageal Toxicity Esophagitis	7 Participants

PRIMARY outcome

Timeframe: 6 weeks (30 treatments, 5 days per week)

Population: 47 participants from this trial and 15 from the previous trial, UMCC 2007.123

Investigators will generate the treatment plan (and hence dose to PET avid region) each patient would have received if they had been treated on protocol UMCC 2007.123 (NCT01190527), which redistributed dose to the PET avid region but not through normal tissue. These dose values will then be compared to the doses actually given to assess for any mean differences.

Outcome measures

Outcome measures
Measure	Response-driven Adaptive RT n=62 Participants Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Comparison of Delivered Dose to Dose That Would Have Been Administered Using the Criteria Described in Protocol UMCC 2007.123 (NCT01190527) UMCC 2007.123 study	80.4 average total physical dose (Gy) Standard Deviation 6.01
Comparison of Delivered Dose to Dose That Would Have Been Administered Using the Criteria Described in Protocol UMCC 2007.123 (NCT01190527) UMCC 2015.035 Study	67.7 average total physical dose (Gy) Standard Deviation 7.7

SECONDARY outcome

Timeframe: Up to 60 months

Defined as the time from start of treatment to time of local/regional progression on PET, summarized with the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Response-driven Adaptive RT n=47 Participants Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Time to Local Progression Locoregional progression-free survival at 1 year	69.2 percentage of patients Interval 57.0 to 84.1
Time to Local Progression Locoregional progression-free survival at 2 years	47.9 percentage of patients Interval 35.1 to 65.3

SECONDARY outcome

Timeframe: Up to 60 months

Defined as the time from start of treatment to death.

Outcome measures

Outcome measures
Measure	Response-driven Adaptive RT n=47 Participants Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Overall Survival Time Overall survival at 1 year	82.8 percentage of patients Interval 72.6 to 94.4
Overall Survival Time Overall survival at 2 year	62.3 percentage of patients Interval 49.6 to 78.3

Adverse Events

Response-driven Adaptive RT

Serious events: 13 serious events

Other events: 47 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Response-driven Adaptive RT n=47 participants at risk Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Cardiac disorders Acute coronary syndrome	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Cardiac disorders Atrial fibrillation	4.3% 2/47 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Cardiac disorders Atrial Flutter	4.3% 2/47 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Bronchopleural fistula	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Diarrhea	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Esophageal hemorrhage	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
General disorders fatigue	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Blood and lymphatic system disorders Febrile neutropenia	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Vascular disorders Hypotension	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Hypoxia	8.5% 4/47 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Infections and infestations Lung infection	8.5% 4/47 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignant neoplasm	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders non-cardiac chest pain	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Nervous system disorders stroke	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Vascular disorders vascular disorders- other, specify	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.

Other adverse events

Other adverse events
Measure	Response-driven Adaptive RT n=47 participants at risk Patients received treatment 5 days per week, in once daily fractions, for 30 treatments with dose per fraction individually adapted over the final 9 treatments. Patients may have also received concurrent chemotherapy with Carboplatin and Paclitaxel. Patients may have received consolidation chemotherapy (carboplatin and paclitaxel) or immunotherapy (durvalumab) at the discretion of the medical oncologist. Response-driven Adaptive Radiation Therapy Carboplatin: AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV Paclitaxel: 40 mg/m\^2 IV concurrent with RT; 200 mg/m\^2 during consolidation. Given IV FDG-PET V/Q SPECT Durvalumab: 10 mg/kg during consolidation. Given IV
Skin and subcutaneous tissue disorders Alopecia	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Aspiration	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Cardiac disorders Atrial fibrillation	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Musculoskeletal and connective tissue disorders chest wall pain	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Hepatobiliary disorders cholecystitis	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders constipation	4.3% 2/47 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders cough	87.2% 41/47 • Number of events 81 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Metabolism and nutrition disorders Dehydration	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Injury, poisoning and procedural complications Dermatitis radiation	53.2% 25/47 • Number of events 38 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Diarrhea	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Dyspepsia	10.6% 5/47 • Number of events 6 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Dyspnea	66.0% 31/47 • Number of events 61 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Esophageal Pain	80.9% 38/47 • Number of events 62 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Esophagitis	83.0% 39/47 • Number of events 73 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
General disorders Fatigue	95.7% 45/47 • Number of events 90 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Gastroesophageal reflux disease	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
General disorders Clinical fibrosis	4.3% 2/47 • Number of events 3 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
General disorders Rib fracture	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Hiccups	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
General disorders Infusion related reaction	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Psychiatric disorders insomnia	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Nausea	4.3% 2/47 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Cardiac disorders Pericardial effusion	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Cardiac disorders pericarditis	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Investigations Platelet count decreased	2.1% 1/47 • Number of events 2 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	10.6% 5/47 • Number of events 5 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	12.8% 6/47 • Number of events 8 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Pneumonitis	21.3% 10/47 • Number of events 13 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Psychiatric disorders Altered mental status	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	8.5% 4/47 • Number of events 4 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Injury, poisoning and procedural complications Radiation recall reaction	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Musculoskeletal and connective tissue disorders superficial soft tissue fibrosis	14.9% 7/47 • Number of events 7 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Infections and infestations Upper respiratory infection	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Gastrointestinal disorders Vomiting	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.
Investigations Weight loss	2.1% 1/47 • Number of events 1 • All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 36 months after the last dose of study treatment. Data was collected during a 6 year period.

Additional Information

ClinicalTrials.gov CC Admin

University of Michigan Rogel Cancer Center

Phone: 734-936-9499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place