Trial Outcomes & Findings for Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas (NCT NCT00319735)
NCT ID: NCT00319735
Last Updated: 2016-04-28
Results Overview
To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas. Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
36 months
Results posted on
2016-04-28
Participant Flow
Participant milestones
| Measure |
Single Arm Assignment
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Arm Assignment
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas
Baseline characteristics by cohort
| Measure |
Single Arm Assignment
n=41 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Age, Customized
Median
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Tumor Site
Esophagus
|
26 participants
n=5 Participants
|
|
Tumor Site
Gastroesophageal Junction
|
15 participants
n=5 Participants
|
|
Disease Stage
IIA
|
10 participants
n=5 Participants
|
|
Disease Stage
IIB
|
7 participants
n=5 Participants
|
|
Disease Stage
III
|
22 participants
n=5 Participants
|
|
Disease Stage
IVA
|
2 participants
n=5 Participants
|
|
Histology
Squamous cell carcinoma
|
9 participants
n=5 Participants
|
|
Histology
Adenocarcinoma
|
32 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
26 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
13 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsTo evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas. Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.
Outcome measures
| Measure |
Single Arm Assignment
n=39 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Complete Pathologic Response (pCR)
|
36.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 36 monthsPopulation: Participants who underwent esophagectomy
To evaluate complete pathologic response rate in patients with esophageal and GE junction carcinomas that underwent esophagectomy. Complete pathologic response (pCR) is defined as the absence of tumor cells on the resected specimen in the esophagus and/or GE junction.
Outcome measures
| Measure |
Single Arm Assignment
n=31 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.
Participants with a pCR
|
48 percentage of participants
Interval 30.0 to 67.0
|
|
Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.
Participants with no pCR
|
52 percentage of participants
Interval 33.0 to 70.0
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: No data was collected or analyzed for this secondary objective.
To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: Grade 3 toxicities occurring in \>5% of participants are reported. Safety data is presented in totality in the adverse events section.
To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Outcome measures
| Measure |
Single Arm Assignment
n=41 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Evaluate Toxicity
Hypernatremia
|
2 participants
|
|
Evaluate Toxicity
Anorexia
|
3 participants
|
|
Evaluate Toxicity
Dehydration
|
3 participants
|
|
Evaluate Toxicity
Dyspagia
|
7 participants
|
|
Evaluate Toxicity
Dyspnea
|
2 participants
|
|
Evaluate Toxicity
Fatigue
|
2 participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: No data was collected or analyzed for this secondary objective.
To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 monthsPopulation: patients with IIA
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Outcome measures
| Measure |
Single Arm Assignment
n=10 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Complete and Partial Response Rate for Patients by Disease Stage: IIA
|
70 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: patients with IIB
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Outcome measures
| Measure |
Single Arm Assignment
n=7 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Complete and Partial Response Rate for Patients by Disease Stage: IIB
|
29 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: patients with Stage III disease
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Outcome measures
| Measure |
Single Arm Assignment
n=22 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Complete and Partial Response Rate for Patients by Disease Stage: III
|
27 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: patients with IIB
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Outcome measures
| Measure |
Single Arm Assignment
n=32 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma
|
28 percentage of participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: patients with IIB
To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas
Outcome measures
| Measure |
Single Arm Assignment
n=9 Participants
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.
Subjects who consent will provide tissue samples.
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Complete and Partial Response Rate for Patients by Histology: Squamous Cell
|
67 percentage of participants
|
Adverse Events
Single Arm Assignment
Serious events: 16 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Assignment
n=41 participants at risk
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
2.4%
1/41 • Number of events 2
|
|
Blood and lymphatic system disorders
BLOOD/BONE MARROW - OTHER (SPECIFY, __)
|
2.4%
1/41 • Number of events 1
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
DEHYDRATION
|
7.3%
3/41 • Number of events 4
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
2.4%
1/41 • Number of events 1
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
2.4%
1/41 • Number of events 1
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
FISTULA, GI / ESOPHAGUS
|
2.4%
1/41 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
FRACTURE
|
2.4%
1/41 • Number of events 1
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
HEMORRHAGE, GI / ESOPHAGUS
|
2.4%
1/41 • Number of events 2
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / ABDOMEN NOS
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA)
|
2.4%
1/41 • Number of events 1
|
|
General disorders
PAIN / BACK
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
2.4%
1/41 • Number of events 1
|
|
Investigations
SODIUM, SERUM-HIGH (HYPERNATREMIA)
|
4.9%
2/41 • Number of events 2
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
THROMBOSIS/THROMBUS/EMBOLISM
|
2.4%
1/41 • Number of events 1
|
|
Renal and urinary disorders
URINARY RETENTION (INCLUDING NEUROGENIC BLADDER)
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
VASCULAR - OTHER (SPECIFY, __)
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
VOMITING
|
2.4%
1/41 • Number of events 1
|
|
General disorders
WEIGHT LOSS
|
2.4%
1/41 • Number of events 1
|
Other adverse events
| Measure |
Single Arm Assignment
n=41 participants at risk
Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks
Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy
Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission
|
|---|---|
|
Investigations
ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA)
|
4.9%
2/41 • Number of events 3
|
|
Immune system disorders
ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER)
|
9.8%
4/41 • Number of events 4
|
|
Immune system disorders
ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP)
|
4.9%
2/41 • Number of events 2
|
|
Investigations
ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE)
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
ANOREXIA
|
22.0%
9/41 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
2.4%
1/41 • Number of events 1
|
|
Investigations
AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE)
|
4.9%
2/41 • Number of events 2
|
|
Investigations
CALCIUM, SERUM-LOW (HYPOCALCEMIA)
|
7.3%
3/41 • Number of events 4
|
|
Investigations
CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA)
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
CONSTIPATION
|
12.2%
5/41 • Number of events 5
|
|
General disorders
CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __)
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
17.1%
7/41 • Number of events 8
|
|
Gastrointestinal disorders
DEHYDRATION
|
4.9%
2/41 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
DERMATOLOGY/SKIN - OTHER (SPECIFY, __)
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
DIARRHEA
|
12.2%
5/41 • Number of events 5
|
|
Gastrointestinal disorders
DRY MOUTH/SALIVARY GLAND (XEROSTOMIA)
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
DYSPHAGIA (DIFFICULTY SWALLOWING)
|
85.4%
35/41 • Number of events 47
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA (SHORTNESS OF BREATH)
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
9.8%
4/41 • Number of events 6
|
|
General disorders
FATIGUE (ASTHENIA, LETHARGY, MALAISE)
|
36.6%
15/41 • Number of events 26
|
|
General disorders
FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L)
|
7.3%
3/41 • Number of events 3
|
|
General disorders
FLU-LIKE SYNDROME
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
GASTROINTESTINAL - OTHER (SPECIFY, __)
|
12.2%
5/41 • Number of events 6
|
|
Investigations
GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA)
|
4.9%
2/41 • Number of events 3
|
|
Gastrointestinal disorders
HEARTBURN/DYSPEPSIA
|
19.5%
8/41 • Number of events 9
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
7.3%
3/41 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE
|
2.4%
1/41 • Number of events 4
|
|
Endocrine disorders
HOT FLASHES/FLUSHES
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
HYPERTENSION
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
HYPOTENSION
|
4.9%
2/41 • Number of events 2
|
|
Infections and infestations
INFECTION - OTHER (SPECIFY, __)
|
4.9%
2/41 • Number of events 2
|
|
Infections and infestations
INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS)
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / CONJUNCTIVA
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS
|
2.4%
1/41 • Number of events 1
|
|
General disorders
INSOMNIA
|
12.2%
5/41 • Number of events 5
|
|
Cardiac disorders
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
2.4%
1/41 • Number of events 1
|
|
Investigations
MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA)
|
17.1%
7/41 • Number of events 11
|
|
Psychiatric disorders
MOOD ALTERATION / DEPRESSION
|
2.4%
1/41 • Number of events 1
|
|
Surgical and medical procedures
MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY
|
9.8%
4/41 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
7.3%
3/41 • Number of events 3
|
|
Gastrointestinal disorders
NAUSEA
|
46.3%
19/41 • Number of events 24
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
PAIN / ABDOMEN NOS
|
7.3%
3/41 • Number of events 3
|
|
General disorders
PAIN / BACK
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / CHEST/THORAX NOS
|
4.9%
2/41 • Number of events 2
|
|
Gastrointestinal disorders
PAIN / ESOPHAGUS
|
7.3%
3/41 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
PAIN / EXTREMITY-LIMB
|
2.4%
1/41 • Number of events 1
|
|
General disorders
PAIN / FACE
|
2.4%
1/41 • Number of events 1
|
|
General disorders
PAIN / HEAD/HEADACHE
|
12.2%
5/41 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
PAIN / JOINT
|
7.3%
3/41 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
PAIN / MUSCLE
|
2.4%
1/41 • Number of events 1
|
|
General disorders
PAIN / PAIN NOS
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PAIN / THROAT/PHARYNX/LARYNX
|
4.9%
2/41 • Number of events 2
|
|
General disorders
PAIN - OTHER (SPECIFY, __)
|
12.2%
5/41 • Number of events 5
|
|
Cardiac disorders
PALPITATIONS
|
2.4%
1/41 • Number of events 1
|
|
Blood and lymphatic system disorders
PLATELETS
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION (NON-MALIGNANT)
|
2.4%
1/41 • Number of events 1
|
|
Investigations
POTASSIUM, SERUM-LOW (HYPOKALEMIA)
|
9.8%
4/41 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
PRURITUS/ITCHING
|
34.1%
14/41 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __)
|
4.9%
2/41 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
RASH/DESQUAMATION
|
2.4%
1/41 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
RASH: ACNE/ACNEIFORM
|
75.6%
31/41 • Number of events 64
|
|
Skin and subcutaneous tissue disorders
RASH: DERMATITIS ASSOCIATED WITH RADIATION / CHEMORADIATION
|
7.3%
3/41 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS)
|
7.3%
3/41 • Number of events 3
|
|
General disorders
RIGORS/CHILLS
|
7.3%
3/41 • Number of events 3
|
|
Nervous system disorders
SEIZURE
|
2.4%
1/41 • Number of events 1
|
|
Investigations
SODIUM, SERUM-LOW (HYPONATREMIA)
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GI / ESOPHAGUS
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
TASTE ALTERATION (DYSGEUSIA)
|
14.6%
6/41 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS)
|
4.9%
2/41 • Number of events 3
|
|
Gastrointestinal disorders
VOMITING
|
22.0%
9/41 • Number of events 16
|
|
General disorders
WEIGHT LOSS
|
14.6%
6/41 • Number of events 7
|
Additional Information
Principal Investigator
Hoosier Cancer Research Network, Inc.
Phone: 317-921-2050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place