NSABP C-11 OPEN Worksheet for Form Entry Combination Chemotherapy Before or After Surgery in Treating Patients With Colorectal Cancer With Liver Metastases That Could Be Removed By Surgery Source Form: NCI FormBuilder:

  1. 8/27/12 8/27/12 -
  2. 8/8/14 8/8/14 - Martin Dugas
  3. 1/9/15 1/9/15 - Martin Dugas
  4. 1/9/15 1/9/15 - Martin Dugas
  5. 9/20/21 9/20/21 -
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September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Colorectal Cancer NCT01189227 Registration - NSABP C-11 OPEN Worksheet for Form Entry - 3105627v1.0

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  1. StudyEvent: NSABP C-11 OPEN Worksheet for Form Entry
    1. No Instruction available.
Person Completing Form, Last Name
Method of Payment (mark primary method only)
Country of residence
Patient gender
Did the patient consent to use of blood samples for testing related to C-11?
Did the patient consent to use of tissue and blood samples for future research to learn about, prevent, or treat cancer?
Did the patient consent to use of tissue and blood samples for research about other problems?
Did the patient consent to future contact about more research?
Has the patient authorized the release of Protected Health Information to the NSABP?
Has the patient received prior oxaliplatin therapy?
Page Headers
Surgery For Primary Colorectal Tumor
Was a diagnosis of colorectal adenocarcinoma confirmed histologically?
Have the primary tumor and regional nodes been resected?
Is there a plan to resect the primary tumor and the liver metastases in a single surgical procedure?
Were the surgical margins clear?
Was there evidence of extrahepatic disease?
Did the patient have chemotherapy for the primary colorectal disease?
Approximately when was the last dose of chemotherapy?
In the past four weeks, has a hepatic surgeon determined that the patient's liver metastases are resectable based on the following criteria? (- A complete resection can be performed in a single operation AND - There are at least two uninvolved contiguous segments of the liver)
Section 2
List of Imaging Evaluations Performed
Evaluation Performed?
Section 2 (continued)
Were hepatic metastases evident on one or more scans?
Were extrahepatic metastases evident on one or more scans?
Patient Characteristics
ECOG Performance Status
Section 3 (continued)
Alkaline Phosphatase
Total Bilirubin
Serum Creatinine
Section 3 (continued)
Platelet Count
Calculated Creatinine Clearance
Section 4
Does the patient have a history of diabetes mellitus?
Does the patient have a diagnosis of anal, small bowel or appendiceal carcinoma?
Has the patient been diagnosed with colorectal malignant diseases other than adenocarcinoma, e.g., sarcoma, lymphoma, carcinoid?
Does the patient have an unresected primary tumor in the colon or rectum with significant symptoms related to obstruction or that will require radiation therapy?
Does the patient have a history of or current evidence of extrahepatic metastases? (Exclude regional nodes that are suspicious on imaging and associated with the primary colorectal cancer if the nodes will be resected with the primary tumor after randomization.)
Does the patient's disease demonstrate radiographic evidence of metastases to portal lymph nodes (node > 1 cm in diameter) not proven by biopsy to be negative?
Has the patient received previous hepatic-directed therapy including hepatic resection and/or ablation, hepatic arterial infusion therapy, or hepatic radiation therapy (exluding incisional or excisional biopsy)?
Has the patient received previous chemotherapy or any other systemic therapy for metastatic colorectal cancer?
Has the patient had a portal vein embolization (PVE) or other hepatic preconditioning techniques already performed or are preconditioning techniques such as PVE planned for this patient?
Is there intent to use ablation to treat any hepatic lesion for this patient?
Does the patient have pre-existing chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) that, in the opinion of the investigator and hepatic surgeon, would limit the patient's ability to undergo hepatic metastasectomy?
Does the patient have grade 3 or 4 anorexia, grade 3 nausea, or >= grade 2 vomiting (per CTCAE v4.0) related to metastatic disease?
Does the patient have paresthesias, peripheral sensory neuropathy, or peripheral motor neuropathy >= grade 2 per CTCAE v4.0 (Exclude grade 2 neuropathy in patients who will receive FOLFIRI in this study)?
Does the patient have a documented history of congestive heart failure requiring chronic medical therapy?
Does the patient require therapeutic doses of coumadin or equivalent?
Does the patient have active inflammatory bowel disease?
Does the patient have an active infection or chronic infection requiring chronic suppressive antibiotics?
Does the patient have any known bleeding diathesis or coagulopathy?
Does the patient have symptomatic interstitial pneumonitis or is the patient asymptomatic with definitive evidence of interstitial pneumonitis described on CT scan, MRI, or chest x-ray?
Has the patient had other malignancies (other than carcinoma in situ of the cervix, colorectal carcinoma in situ, melanoma in situ, or basal cell or squamous cell carcinoma of the skin that has been treated)?
Is patient considered to be disease-free?
Did the patient complete therapy for the malignancies >= 1 year ago?
Is the patient known to have Gilbert's Syndrome?
Is the patient known to be homozygous for the UGT1A1 28 allele?
Has the patient experienced a previous serious hypersensitivity reaction to any of the agents the patient will receive as part of the C-11 trial?
Does the patient have any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the patient, compromise the patient's ability to participate in the study, or cause a delay in the initiation of therapy (surgery or chemotherapy) longer than 4 weeks following randomization?
Does the patient have psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude the patient from meeting the study requirements?
Has the patient taken any investigational product within the past 30 days?
Is the patient a woman of child-bearing potential? (The following questions are to be completed for female patients only.)
Was a pregnancy test performed?
Is the patient pregnant or lactating at time of study entry?

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