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| ID | Type | Description | Link |
|---|---|---|---|
| J09150 | Other Identifier | SKCCC Number |
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This study is an open label prospective trial of TheraSphere treatment for patients who have liver metastases who have failed or are intolerant to other systemic or liver directed therapies. Patients will be treated with TheraSphere at doses of 120 ± 10% Gy, and then followed for time to progression (TTP), safety, and overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TheraSphere | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraSphere, Yttrium-90 glass Microspheres | Device | Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each treated lobe. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria | This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported. | Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. |
| Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria | Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria | This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported. | Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. |
Not provided
Inclusion Criteria
A patient is considered to have failed to other systemic or liver-directed therapies when, in the opinion of the referring physician, the patient has progression of disease after receiving standard approved therapies. Specifically, if a patient has failed first line chemotherapy (or the standard approved therapies for that particular solid tumor), in the time period designed to assess that particular regimen (at least 30 days), then they may be enrolled into this protocol.
A patient is intolerant to other systemic or liver-directed therapies when, in the opinion of the referring physician, for example, the patient is unable to tolerate appropriate chemotherapy, when the patient had residual toxicity from previous therapies (e.g. neuropathy from oxaliplatin), or when the patient's performance status is such that treatment with systemic therapies would result in excessive toxicity.
Liver metastases are unresectable
Target tumors should be measurable using standard imaging techniques
Tumor replacement ≤ 70% of total liver volume based on visual estimation by the Investigator
Tumors are hypervascular based on visual estimation by the Investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
At least one month has elapsed since most recent prior cancer therapy with the following exceptions
Patient is willing to participate in the study and has signed the study informed consent
Exclusion Criteria
At risk of hepatic or renal failure, as indicated by any of the following pre-treatment laboratory and clinical findings within 28 days of treatment:
Contraindications to angiography and selective visceral catheterization that may include, but are not limited to, the following:
Severe liver dysfunction or presentation of pulmonary insufficiency or a clinically evident history of chronic obstructive pulmonary disease
Cirrhosis or portal hypertension
Previous external beam radiation treatment to the liver
Any intervention for, or compromise of the Ampulla of Vater
Clinically evident ascites. (Note: A radiographic finding of trace ascites on imaging is acceptable).
Any continuing complications of prior cancer therapy that have not improved or resolved prior to 21 days before the first treatment with TheraSphere (if the investigator determines that the continuing complication will compromise the safety of the patient following treatment with TheraSphere).
In the judgment of the physician, significant life-threatening extrahepatic disease
Concurrent enrollment in another clinical study
Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates lung shunting with a potential absorbed dose of radiation to the lungs >30 Gy. The 30 Gy limit is a cumulative limit over all infusions of TheraSphere.
Evidence on technetium-99m macroaggregated albumin (99mTc-MAA) scan that demonstrates a potential for the deposition of microspheres to the gastrointestinal tract that cannot be corrected by placement of the catheter distal to collateral vessels or using standard angiographic techniques, such as coil embolization.
A positive serum pregnancy test in women of childbearing potential
In the Investigator's judgment, any co-morbid disease or condition or event (e.g., recent myocardial infarction) that would place the patient at undue risk, and that would preclude safe use of TheraSphere
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Geschwind, M.D. | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287-4010 | United States |
Not provided
This study enrolled patients diagnosed with unresectable hepatic metastases who have failed or were intolerant to at least one line of systemic chemotherapy or liver-directed therapy. Participants were enrolled at Johns Hopkins Hospital with the last patient completed in April 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | TheraSphere | TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TheraSphere | TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Progression (TTP) of the Treated Lesion(s) According to RECIST Criteria | This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported. | These data were not collected. See outcome measure #2. | Posted | Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. |
|
12 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TheraSphere | TheraSphere, Yttrium-90 glass Microspheres: Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death (disease progression) | General disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Distension/bloating, abdominal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean-Francois Geschwind, MD | Yale University | 203-785-5865 | jeff.geschwind@yale.edu |
Not provided
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D000230 | Adenocarcinoma |
| D009380 | Neoplasms, Nerve Tissue |
| D008107 | Liver Diseases |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| D018278 | Carcinoma, Neuroendocrine |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
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|
| Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 |
Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, at 4 weeks post treatment, and subsequent 3 month intervals. Complete Response (CR): Disappearance of all lesions targeted by Y90 Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by Y90 Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by Y90 Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD. |
| 12 months |
| Tumor Response by the European Association for the Study of the Liver (EASL) Criteria | Efficacy as assessed by radiographic tumor response using EASL criteria at baseline up to 12 months post treatment. Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions. | 12 months |
| Overall Survival (OS) | Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. | Median follow-up time was 11.41 months (CI: 1.5-33.7) |
| Overall Survival (OS) Rate at 2 Years | Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". At the time of results reporting, this outcome was presented as "Up to 2 years". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. 2-year OS rates were also stratified based on tumor burden. | Up to 2 years |
| Safety as Graded by CTCAE Version 3.0 | Clinical and biochemical toxicity that were assessed as at least possibly related to treatment were recorded from the day of treatment until protocol exit or death. Toxicities were graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. | 12 months |
| Mean Radiation Dose Delivered to Total Liver | Therasphere dose calculation was performed using positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography (SPECT) imaging post-procedure to estimate the actual delivered dose of Theraspheres to the liver. | 24 hours |
| Required additional Y90 treatment |
|
| Change in treatment modality |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | Progression-free Survival (PFS) of the Treated Lesion(s) According to RECIST and EASL Criteria | Progression-free survival was defined as the time from the date of Y-90 radioembolization to date of disease progression or latest follow-up. PFS was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. RECIST and EASL criteria were used to assess progression with kappa value for intermethod agreement of treatment responses of 0.9. | Median PFS for all subjects and stratified based on disease type. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
|
| Secondary | Time to Progression (TTP) of the Treated Lesion(s) According to EASL Criteria | This outcome was not assessed. Instead, the primary outcome of progression-free survival based on RECIST and EASL criteria was assessed and reported. | Analysis for TTP was not performed. In lieu of TTP, the PFS based on RECIST and EASL criteria was analyzed. | Posted | Evaluated 4 weeks following each TheraSpheres procedure, and at 2-3 month intervals thereafter. |
|
|
| Secondary | Tumor Response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 | Efficacy as assessed by radiographic tumor response using RECIST criteria at baseline, at 4 weeks post treatment, and subsequent 3 month intervals. Complete Response (CR): Disappearance of all lesions targeted by Y90 Partial Response (PR): At least 30% decrease in the sum of longest diameter (LD) of lesions targeted by Y90 Progressive Disease (PD): At least 20% increase in sum of LD of lesions targeted by Y90 Stable Disease (SD): Neither sufficient shrinkage for PR nor sufficient increase for PD. | RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12). | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Tumor Response by the European Association for the Study of the Liver (EASL) Criteria | Efficacy as assessed by radiographic tumor response using EASL criteria at baseline up to 12 months post treatment. Complete Response (CR): Achieving 100% tumor necrosis of targeted lesions Partial Response (PR): Demonstrating greater than 50% tumor necrosis in targeted lesions Progressive Disease (PD): Reappearance of or increased tumor enhancement greater than 25% in targeted lesions Stable Disease (SD): Not meeting requirements for CR or PR and not demonstrating evidence of progression in targeted lesions. | RECIST for all applicable patients (n=43) were analyzed and also stratified based on disease type: CRC (n=9); NE (n=22); and non-CRC/non-NE (n=12). 7 out of the 50 patients were not analyzed due to lack of follow-up imaging. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Overall Survival (OS) | Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. | Median OS for all patients (n=50) were analyzed and also stratified based on disease type: CRC (n=12); NE (n=26); and non-CRC/non-NE (n=12). | Posted | Median | 95% Confidence Interval | months | Median follow-up time was 11.41 months (CI: 1.5-33.7) |
|
|
|
| Secondary | Overall Survival (OS) Rate at 2 Years | Measured from the date corresponding to initiation of therapy until the date of death due to any cause. At the time of registration, the outcome measure was entered in clinicaltrials.gov as "open-ended". At the time of results reporting, this outcome was presented as "Up to 2 years". Overall survival was analyzed via Kaplan-Meier methodology with log-rank test using all 50 patients on study and stratified based on disease type. 2-year OS rates were also stratified based on tumor burden. | 2-year OS rate for all patients (n=50) were analyzed and also stratified based on tumor burden: Patients with tumor burden of 25% or less (n=34) and patients with tumor burden greater than 25% (n=16). | Posted | Number | percentage of participants | Up to 2 years |
|
|
|
| Secondary | Safety as Graded by CTCAE Version 3.0 | Clinical and biochemical toxicity that were assessed as at least possibly related to treatment were recorded from the day of treatment until protocol exit or death. Toxicities were graded by the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. | 50 participants were assessed for adverse events, with a total of 207 adverse events reported. Two patients had grade 5 toxicities (grade 5 cholecystitis and death), which were attributed to disease progression and were not device-related. | Posted | Number | adverse events | 12 months | Adverse Events | Adverse Events |
|
|
|
| Secondary | Mean Radiation Dose Delivered to Total Liver | Therasphere dose calculation was performed using positron emission tomography-computed tomography (PET/CT) and single-photon emission computed tomography (SPECT) imaging post-procedure to estimate the actual delivered dose of Theraspheres to the liver. | Mean radiation doses were calculated for the total cohort of participants and also stratified according to disease type - colorectal cancer, neuroendocrine, and non-CRC/non-NE. | Posted | Mean | Standard Deviation | Gray | 24 hours |
|
|
|
| 4 |
| 50 |
| 14 |
| 50 |
| 48 |
| 50 |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Brain surgery for metastatic disease | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Failure to thrive | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acetaminophen overdose | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Liver failure | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema: trunk | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Diaphoresis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Elevated AST | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Elevated ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acid reflux | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anal fissure | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematochezia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Elevated INR | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Concentration impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Night sweat | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Weight gain | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flushing | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - general | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - site of incision | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain - non-cardiac | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - stomach | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lower extremity edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Visual changes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot flash | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
|
| Median PFS for NE |
|
|
| Median PFS for non-CRC/non-NE |
|
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Colorectal cancer only |
|
|
| Neuroendocrine only |
|
|
| Non-CRC/Non-NE |
|
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Colorectal cancer only |
|
|
| Neuroendocrine only |
|
|
| Non-CRC/Non-NE |
|
|
|
| Median OS for NE |
|
|
| Median OS for non-CRC/non-NE |
|
|
|
| OS rate for tumor burden 25% or less |
|
|
| Title | Measurements |
|---|---|
|
| Lymphocyte depression (asymptomatic) |
|
| Fatigue |
|
| Fever |
|
| Nausea |
|
| Heartburn |
|
| Vomiting |
|
| Pain |
|
| Decreased albumin |
|
| Elevated bilirubin |
|
| Anorexia |
|
| Weight loss |
|
| Constipation |
|
| Muscle pain |
|
| Cholecystitis |
|
| Death (disease progression) |
|
| Allergic reaction (contrast media) |
|
| Thrombosis/embolism (vascular access) |
|
| Liver failure |
|
|
| Mean dosing for NE |
|
|
| Mean dosing for non-CRC/non-NE |
|
|