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Paclitaxel, Cisplatin, and Radiation Therapy With or Without Cetuximab in Treating Patients With Locally Advanced Esophageal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A16F93C-C68B-2E25-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=2A16F93C-C68B-2E25-E044-0003BA3F9857

Keywords:

Esophageal Neoplasms

Clinical Trial

Baseline

Versions (4)

9/19/12 9/19/12 -
1/9/15 1/9/15 - Martin Dugas
6/21/15 6/21/15 -
8/4/15 8/4/15 - Martin Dugas

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August 4, 2015

DOI:

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Creative Commons BY-NC 3.0 Legacy

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Initial Evaluation Form Esophageal Cancer RTOG NCT00655876

English 1

English

Details

No Instruction available.

1 forms

StudyEvent: I1: Radiation Therapy Oncology Group Phase III Esophagus Initial Evaluation Form
1. No Instruction available.

Module 1

RTOG Study No.

RTOG Case #

Institution Name

Institution No.

Patient Initials

RTOG Patient ID

AMENDED DATA

Yes

Patient status assessment

Age

years

Performance Status (Zubrod)

Normal Activity (0)

Symptoms, But Nearly Fully Ambulatory (1)

Some Bed Time, But Needs To Be In Bed <50% Of Normal Daytime (2)

Needs To Be In Bed > 50% Of Normal Daytime (3)

Unable To Get Out Of Bed (4)

History of Prior Malignancy (except non melanomatous skin cancer)

Yes

Site of Prior Cancer

Prior cancer date eradicated

Weight

Extent of Dysphagia

Asymptomatic (Asymptomatic)

Cannot Swallow (Cannot swallow)

Symptomatic, Liquids Only (Symptomatic, liquids only)

Symptomatic, Soft Foods Only (Symptomatic, soft foods only)

Symptomatic, Unrestricted Diet (Symptomatic, unrestricted diet)

Unknown (Unknown)

Oral alimentation

No (No)

Unknown (Unknown)

Yes (Yes)

Nasogastric tube feeding

No (No)

Unknown (Unknown)

Yes (Yes)

Ostomy feeding

No (No)

Unknown (Unknown)

Yes (Yes)

Intravenous hyperalimentation

No (No)

Unknown (Unknown)

Yes (Yes)

Other

No (No)

Unknown (Unknown)

Yes (Yes)

Other Specify

Estimate of daily caloric intake

< 1500 Cal/day (< 1500 cal/day)

>= 1500 Cal/day (>= 1500 cal/day)

Prior Treatment

Prior Surgery (for esophageal cancer excludes diagnostic biopsy)

Yes

Prior chemotherapy (for study cancer)

Yes

Prior chemotherapy (for other reasons)

Yes

Prior radiation therapy (to chest)

Yes

Prior therapy that targeted EGFR pathway

Yes

Prior platinum based and/or paclitaxel based therapy

Yes

Study Cancer

Site of study cancer

Upper Thoracic Esophagus (Upper thoracic esophagus)

Mid Thoracic Esophagus (Mid thoracic esophagus)

Lower Thoracic Excludes Ge Junction (Lower thoracic excludes GE junction)

Cervical Esophagus (Cervical Esophagus)

Gastroesophageal Junction, Siewert Type I (Gastroesophageal junction, Siewert Type I)

Gastroesophageal Junction, Siewert Type Ii (Gastroesophageal junction, Siewert Type II)

Histologic Type

Squamous Cell Carcinoma (Squamous cell carcinoma)

Adenocarcinoma (Adenocarcinoma)

Date of initial histologic diagnosis of malignancy

Cervical esophagus

Yes

Invasion into the trachea or major bronchi

Yes

Evidence of tracheoesophageal fistule

Yes

Esophageal Tumor Clinical T Stage

Tumor Invades Lamina Propria Or Submucosa (T1)

Tumor Invades Muscularis Propria (T2)

Tumor Invades Adventitia (T3)

Tumor Invades Adjacent Structures (T4)

Is the tumor proximal thoracic

Yes

Clinical N Stage

No Regional Lymph Node Metastasis (N0)

Regional Lymph Node Metastasis (N1)

Clinical M Stage

No Distant Metastasis (M0)

Metastases Present - See Figo And Ajcc Staging For Complete Details (M1a)

Celiac lymph nodes

Yes

Cervical lymph nodes

Yes

Supraclavicular lymph nodes

Yes

Laboratory Tests

Hemoglobin

g/dL

ANC

1000/ul

Peripheral Platelet Count

1000/uL

Serum creatinine

mg/dL

AST (SGOT)

U/L

AST (SGOT) ULN

U/L

Bilirubin, total

mg/dL

Total bilirubin ULN

mg/dL

Date

Diagnosis Work-up

History and Physical

Yes

CT scan or MRI of the chest or abdomen

Yes

Endoscopic biopsy of esophageal tumor

Yes

EKG

Yes

Bronchoscopy

Yes

PET/CT

Yes

Date

Co-morbidties

Hospitalized for unstable angina and/or CHF in last 6 months

Yes

Transmural MI in last 6 months

Yes

IV antibiotics at time of registration

Yes

COPD exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at registration

Yes

Prior allergic reaction to cisplatin

Yes

Prior allergic reaction to C225

Yes

Prior allergic reaction to taxol

Yes

Prior severe infusion reaction to a monocolonal antibody

Yes

Footer

Comments

Investigator Signature (The reported case report information has been reviewed and confirmed by the principal investigator)

Date

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Initial Evaluation Form Esophageal Cancer RTOG NCT00655876

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