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NSABP PROTOCOL R-04: SURGERY FORM Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7ABE177-6C54-3DC5-E034-0003BA12F5E7

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B7ABE177-6C54-3DC5-E034-0003BA12F5E7

Keywords:

Colorectal Neoplasms

Clinical Trial

Treatment Form

Versions (2)

8/27/12 8/27/12 -
1/9/15 1/9/15 - Martin Dugas

Uploaded on:

January 9, 2015

DOI:

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License :

Creative Commons BY-NC 3.0 Legacy

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Colorectal Cancer NCT00058474 Treatment - NSABP PROTOCOL R-04: SURGERY FORM - 2086952v3.0

English 1

English

Details

(If a resection was not performed, submit supporting documentation and leave the remainder of the form blank.)

1 forms

StudyEvent: NSABP PROTOCOL R-04: SURGERY FORM
1. (If a resection was not performed, submit supporting documentation and leave the remainder of the form blank.)

Ccrr Module For Nsabp Protocol R-04: Surgery Form

Last

First

Middle

NSABP Patient ID

Person Completing Form, Last Name (Person Completing Form, First Name)

Person Completing Form, First Name

Person Completing Form, Phone

Institution Name / Affiliate

Are data amended

Yes

Perioperative Tumor Assessment Of Clinical Response

Method of Evaluation

Date of Assessment

Clinical response

Not Done (Not done)

Tumor Absent (Tumor absent)

Tumor Present (Tumor present)

Clinical response

Not Done (Not done)

Tumor Absent (Tumor absent)

Tumor Present (Tumor present)

Vascular Access Device

Date of placement

Type (MARK ONE)

Port-a-cath (Implanted port)

Percutaneous Catheter (Percutaneous catheter)

Peripherally Inserted Central Venous Catheter (PIC line)

Blood Transfusions

Blood transfusion

Intraoperative (Intraoperative)

Preoperative (Preoperative)

Within 30 Days Post-operative (Within 30 days post-operative)

Total units whole blood

Total number of units PRBC

Surgery

Did patient undergo surgical resection?

Yes

Date of Resection (month day year)

Reason for no resection

Death (Death)

Local Regional Tumor Growth (Local regional tumor growth)

Metastatic Disease (Metastatic disease)

Other (Other)

Patient Refused (Patient refused)

Second Primary Cancer (Second primary cancer)

Other, specify

Found on

Intra-operatively (Intra-operatively)

Pre-op Diagnostic Testing (Pre-op diagnostic testing)

Is there adherence to adjacent organs?

Yes

Was an "en bloc" resection performed?

Yes

Residual Primary Tumor

Yes

Was an abdominal exploration carried out?

Yes

Was there tumor spillage?

Yes

Was sphincter preserved

Yes

Was a total mesorectal excision performed?

Yes

Were all suspicious lymph nodes removed?

Yes

Were there any isolated distant or non-contiguous intra-abdominal mets (other than peri-rectal lymph node involvement)?

Yes

Metastasis completely resected

No (No)

Yes (Yes)

Not Applicable (Not Applicable)

Was there bowel perforation

Yes

Indicate the type (perforation)

Contained (Contained)

Free (Free)

Was there bowel obstruction

Yes

Indicate the type (tumor)

Partial (Partial)

Complete (Complete)

Was an ostomy created at the time of resection?

Yes, Colostomy (Yes, colostomy)

Yes, Ileostomy (Yes, ileostomy)

No (No)

Number of primary tumors

Location of distal edge of tumor

Upper Rectum (11 Or More Cm From The Anal Verge) (Upper rectum (11 or more cm from the anal verge))

Middle Rectum (6-10 Cm From The Anal Verge) (Middle rectum (6-10 cm from the anal verge))

Lower Rectum (0-5 Cm From The Anal Verge) (Lower rectum (0-5 cm from the anal verge))

Were there any Post-operative and Early Complications

Yes

Mark all that apply

Anastomotic Leak (Anastomotic leak)

Bowel Obstruction/ileus (Bowel obstruction/ileus)

Cardiopulmonary Complication (Cardiopulmonary complication)

Death (Death)

9 more items in the detailed view.

Other, specify

Wound infection, mark type

Abdominal (Abdominal)

Perineal (Perineal)

Urinary complication, choose type

Retention (Retention)

Infection (Infection)

Other (Other)

Was a re-operation necessary?

Yes

Pathology

Pathology Accession Number

Pathologic T Stage

No Evidence Of Primary Tumor (T0)

Tumor Invades Submucosa (T1)

Tumor Invades Muscularis Propria (T2)

Tumor Invades Through The Muscularis Propria Into The Subserosa, Or Into Nonperitonealized Pericolic Or Perirectal Tissues (T3)

3 more items in the detailed view.

Number of Lymph Nodes Examined

Number of Positive Lymph Nodes

Pathologic response

Evidence Of Invasive Tumor Cells (Evidence of invasive tumor cells)

No Evidence Of Invasive Tumor Cells (No evidence of invasive tumor cells)

Longest Dimension of Tumor (cm)

Histologic Type (mark one)

Adenocarcinoma (Adenocarcinoma)

Adenosquamous carcinoma (Adenosquamous carcinoma)

Medullary carcinoma (Medullary carcinoma)

Mucinous (colloid) carcinoma (Mucinous (colloid) carcinoma)

5 more items in the detailed view.

Other, specify (histologic type)

Venous Invasion

Yes (Yes)

No (No)

Unknown (Unknown)

Indeterminate (Indeterminate)

Histologic Grade (Differentiation)

High Grade (poor Differentiation And/or Undifferentiated) (High grade)

Low Grade (well And/or Moderate Differentiation) (Low grade)

All surgical margins of resection are negative for tumor

Yes

Which margin was involved?

Circumferential (Circumferential)

Distal (Distal)

Proximal (Proximal)

Distance from Primary Tumor to Distal Margin of Resection

Distance from Primary Tumor to Proximal Margin of Resection

Distance to Nearest Radial Margin (Circumferential)

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Colorectal Cancer NCT00058474 Treatment - NSABP PROTOCOL R-04: SURGERY FORM - 2086952v3.0

(If a resection was not performed, submit supporting documentation and leave the remainder of the form blank.)

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