Description:

N1048 Eligibility Checklist Chemotherapy Alone or Chemotherapy Plus Radiation Therapy in Treating Patients With Locally Advanced Rectal Cancer Undergoing Surgery Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE19C52B-5D67-27CC-E040-BB89AD437F7F

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AE19C52B-5D67-27CC-E040-BB89AD437F7F

Keywords:
Versions (3) ▾
  1. 8/27/12
  2. 1/9/15
  3. 9/20/21
Uploaded on:

September 20, 2021

DOI:
No DOI assigned. To request one please log in.
License:
Creative Commons BY-NC 3.0 Legacy
Model comments:

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for:

Item comments for:

In order to download data models you must be logged in. Please log in or register for free.

Colorectal Cancer NCT01515787 Eligibility - N1048 Eligibility Checklist - 3287509v1.0

NCCTG through Alliance for Clinical Trials in Oncology ("Alliance")

Protocol Administration
Required Characteristics
Age >= 18 years (at diagnosis)
Diagnosis of rectal adenocarcinoma
Measurable disease as defined in Section 11.0
ECOG performance status (PS) 0, 1, or 2
For this patient, the standard treatment recommendation in the absence of a clinical trial would be combined modality neoadjuvant chemoradiation followed by curative intent surgical resection
Candidate for sphincter-sparing surgical resection prior to neoadjuvant therapy according to the primary surgeon
Primary surgeon is credentialed in Total Mesorectal Excision (TME) by the Alliance Surgery Committee (see Appendix IX)
Clinical Stage: T2N1, T3N0, T3N1. Clinical staging should be estimated based on the combination of the following assessments: physical exam by the primary surgeon, CT scan of the chest/abdomen/pelvis, and either a pelvic MRI or an ultrasound (ERUS).
Preoperative proctoscopy with tumor tissue evident between 5 to 12 cm from the anal verge, inclusive.
The following laboratory values obtained <= 28 days prior to registration
Absolute neutrophil count (ANC) >=1,500/mm^3
Platelet count >= 100,000/mm^3
1000/uL
Hemoglobin >8 g/dL
g/dL
Total bilirubin <=1.5 x upper limit of normal (ULN)
SGOT (AST) <=3 x ULN
SGPT (ALT) <=3 x ULN
Creatinine <=1.5 x ULN
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
Patient of child-bearing potential is willing to employ adequate contraception
Provide informed written consent
Willing to return to enrolling medical site for all study visits
Exclusion Criteria - All Responses In Section Below Must Be "no."
Clinical T4 tumors
Primary surgeon indicates need for abdominaloperineal (APR) at baseline
Evidence that tumor is adjacent to (defined as within 3 mm of) the mesorectal fascia on pre-operative MRI or ERUS/pelvic CT scan
Tumor is causing symptomatic bowel obstruction
Chemotherapy within 5 years prior to registration (Hormonal therapy is allowable if the disease-free interval is >= 5 years)
Any prior pelvic radiation
Other invasive malignancy <= 5 years prior to registration. Exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix
Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception.
Co-morbid systemic illnesses or other concurrent disease which, in the judgment of the clinician obtaining informed consent, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Pre-registration Check
Consent form signed and dated
Authorization for use and disclosure of protected health information signed and dated (U.S.A, institutions only If not a USA institution check NA)
Treatment cannot begin prior to registration and must begin <=21 days after registration
Pretreatment tests/procedures must be completed <= 28 days prior to registration (see Section 4.0)
All required baseline conditions must be documented and graded (see Section 10.51)
Treatment on this protocol must commence at the accruing membership site under the supervision of an Alliance or CTSU member physician
Ran
Patient has given permission to the Alliance to store and use his/her blood samples for use in future research to learn about, prevent, or treat cancer
Patient has given permission to the Alliance to store and use his/her blood samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Patient has given permission to the Alliance to give his/her stored blood samples for use in future research to outside researchers
Patient has given permission to the Alliance to collect and store his/her tissue samples for use in future research to learn about, prevent, or treat cancer
Patient has given permission to the Alliance to collect and store his/her tissue samples for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Patient has given permission for the Alliance to give his/her stored tissue samples for use in future research to outside researchers
Grouping Factor
ECOG Performance Status

Similar models