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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Walther Cancer Institute | OTHER |
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The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as cetuximab combined with radiation shows promising results. EGFR inhibitory agents also enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These interactions may represent the principle effects that contribute to the synergy between EGFR and radiation.
This trial will investigate the feasibility and activity of this combination in patients with surgically resectable disease.
OUTLINE: This is a multi-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Treatment | Experimental |
Subjects who consent will provide tissue samples. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Procedure | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Pathologic Response (pCR) | 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. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Pathological Response Rate for Patients 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. | Up to 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Becerra, M.D. | Hoosier Oncology Group, LLC | Study Chair |
| Nasser Hanna, M.D. | Hoosier Oncology Group, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical & Surgical Specialists, LLC | Galesburg | Illinois | 61401 | United States | ||
| Indiana University Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24084441 | Result | Becerra CR, Hanna N, McCollum AD, Becharm N, Timmerman RD, DiMaio M, Kesler KA, Yu M, Yan T, Choy H. A phase II study with cetuximab and radiation therapy for patients with surgically resectable esophageal and GE junction carcinomas: Hoosier Oncology Group G05-92. J Thorac Oncol. 2013 Nov;8(11):1425-9. doi: 10.1097/JTO.0b013e3182a46c3b. |
| Label | URL |
|---|---|
| Hoosier Oncology Group Home Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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| Surgery | Procedure | 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 | Procedure | 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 |
|
| Time to Relief of Dysphagia | To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab | 36 months |
| Evaluate Toxicity | To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | 36 months |
| Perform Exploratory Molecular Correlates. | To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy. | 36 months |
| Complete and Partial Response Rate for Patients by Disease Stage: IIA | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | 36 months |
| Complete and Partial Response Rate for Patients by Disease Stage: IIB | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | 36 months |
| Complete and Partial Response Rate for Patients by Disease Stage: III | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | 36 months |
| Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | 36 months |
| Complete and Partial Response Rate for Patients by Histology: Squamous Cell | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | 36 months |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Community Regional Cancer Center | Indianapolis | Indiana | 46256 | United States |
| AP&S Clinic | Terre Haute | Indiana | 47804 | United States |
| Siteman Cancer Center | St Louis | Missouri | 63110 | United States |
| Texas Oncology, PA | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Tumor Site | Number | participants |
| |||||||||||||||||||||||
| Disease Stage | Stage I, Stage II, and Stage III Cancer is present. The higher the number, the larger the cancer tumor and the more it has spread into nearby tissues. Stage IV The cancer has spread to distant parts of the body. | Number | participants |
| ||||||||||||||||||||||
| Histology | Number | participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead: | Number | participants |
|
| 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 | Complete Pathologic Response (pCR) | 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. | Posted | Number | percentage of participants | 36 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Complete Pathological Response Rate for Patients 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. | Participants who underwent esophagectomy | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 36 months |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Relief of Dysphagia | To evaluate time to relief of dysphagia in patients with esophageal and GE junction carcinomas receiving preoperative radiation and cetuximab | No data was collected or analyzed for this secondary objective. | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Evaluate Toxicity | To evaluate the overall toxicities of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | Grade 3 toxicities occurring in >5% of participants are reported. Safety data is presented in totality in the adverse events section. | Posted | Number | participants | 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Perform Exploratory Molecular Correlates. | To perform exploratory molecular correlates to determine the mechanisms of response and resistance to cetuximab and radiation therapy. | No data was collected or analyzed for this secondary objective. | Posted | 36 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Complete and Partial Response Rate for Patients by Disease Stage: IIA | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | patients with IIA | Posted | Number | percentage of participants | 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Complete and Partial Response Rate for Patients by Disease Stage: IIB | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | patients with IIB | Posted | Number | percentage of participants | 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Complete and Partial Response Rate for Patients by Disease Stage: III | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | patients with Stage III disease | Posted | Number | percentage of participants | 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | patients with IIB | Posted | Number | percentage of participants | 36 months |
|
| |||||||||||||||||||||||||||
| Secondary | Complete and Partial Response Rate for Patients by Histology: Squamous Cell | To evaluate complete and partial response rate of preoperative radiation and cetuximab in patients with esophageal and GE junction carcinomas | patients with IIB | Posted | Number | percentage of participants | 36 months |
|
|
Not provided
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 | 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 | 16 | 41 | 39 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| BLOOD/BONE MARROW - OTHER (SPECIFY, __) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DEHYDRATION | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DYSPHAGIA (DIFFICULTY SWALLOWING) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FISTULA, GI / ESOPHAGUS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FRACTURE | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| HEMORRHAGE, GI / ESOPHAGUS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / ABDOMEN NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION - OTHER (SPECIFY, __) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / BACK | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / CHEST/THORAX NOS | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SODIUM, SERUM-HIGH (HYPERNATREMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| SODIUM, SERUM-LOW (HYPONATREMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| THROMBOSIS/THROMBUS/EMBOLISM | Vascular disorders | CTCAEv3 | Non-systematic Assessment |
| |
| URINARY RETENTION (INCLUDING NEUROGENIC BLADDER) | Renal and urinary disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VASCULAR - OTHER (SPECIFY, __) | Vascular disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| WEIGHT LOSS | General disorders | CTCAEv3 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) | Immune system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | Immune system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| ANOREXIA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ASPIRATION | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| CALCIUM, SERUM-LOW (HYPOCALCEMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DEHYDRATION | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DERMATOLOGY/SKIN - OTHER (SPECIFY, __) | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DIARRHEA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DRY MOUTH/SALIVARY GLAND (XEROSTOMIA) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DYSPHAGIA (DIFFICULTY SWALLOWING) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| ESOPHAGITIS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| FLU-LIKE SYNDROME | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| GASTROINTESTINAL - OTHER (SPECIFY, __) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HEMOGLOBIN | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HOT FLASHES/FLUSHES | Endocrine disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HYPERTENSION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| HYPOTENSION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION - OTHER (SPECIFY, __) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS) | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC / CONJUNCTIVA | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS | Infections and infestations | CTCAEv3 | Non-systematic Assessment |
| |
| INSOMNIA | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| LEUKOCYTES (TOTAL WBC) | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| MOOD ALTERATION / DEPRESSION | Psychiatric disorders | CTCAEv3 | Non-systematic Assessment |
| |
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY | Surgical and medical procedures | CTCAEv3 | Non-systematic Assessment |
| |
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| NAIL CHANGES | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| NEUROPATHY: SENSORY | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / ABDOMEN NOS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / BACK | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / CHEST/THORAX NOS | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / ESOPHAGUS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / EXTREMITY-LIMB | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / FACE | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / HEAD/HEADACHE | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / JOINT | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / MUSCLE | Musculoskeletal and connective tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / PAIN NOS | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN / THROAT/PHARYNX/LARYNX | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PAIN - OTHER (SPECIFY, __) | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PALPITATIONS | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PLATELETS | Blood and lymphatic system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PLEURAL EFFUSION (NON-MALIGNANT) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RASH: DERMATITIS ASSOCIATED WITH RADIATION / CHEMORADIATION | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS) | Skin and subcutaneous tissue disorders | CTCAEv3 | Non-systematic Assessment |
| |
| RIGORS/CHILLS | General disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SEIZURE | Nervous system disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SODIUM, SERUM-LOW (HYPONATREMIA) | Investigations | CTCAEv3 | Non-systematic Assessment |
| |
| STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GI / ESOPHAGUS | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION | Cardiac disorders | CTCAEv3 | Non-systematic Assessment |
| |
| TASTE ALTERATION (DYSGEUSIA) | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS) | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | CTCAEv3 | Non-systematic Assessment |
| |
| WEIGHT LOSS | General disorders | CTCAEv3 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Hoosier Cancer Research Network, Inc. | 317-921-2050 | jsmith@hoosiercancer.org |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013514 | Surgical Procedures, Operative |
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| III |
|
| IVA |
|
| 2 |
|
|
|
|
|
|
|
|
|