NEO-RT Trial:PhIII RandomNeoadjChemo Excision&Obs Vs Chemoradiothe forEarly RectalCa

UCI Specialty Area: Cancer

Principal Investigator: Jason Zell

Official Title: The NEO-RT Trial: A Phase III Randomized Trial of Neoadjuvant Chemotherapy, Excision and Observation Versus Chemoradiotherapy for Early Rectal Cancer

A Study On:

Rectum

Study Description

This study is being done to answer the following questions: Is the chance of rectal cancer responding the same if chemotherapy alone is given before limited surgery compared to chemotherapy and radiation therapy given together before limited surgery? If radiation therapy is not given, is quality of life better?

Eligibility

-Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma, mismatch repair proficient.

-MRI stage cT1 not eligible for transanal surgery or cT2.

-cN0 stage based on pelvic MRI - including absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or extramural venous invasion (EMVI).

-M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.

-Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.

-Medically fit to undergo radical TME surgery as per treating surgeon's decision.

-You must be able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French or Spanish.

-Age of at least 18 years.

-No contraindications to protocol chemotherapy.

-You must be accessible for treatment and follow-up

-Women/men of childbearing potential must have agreed to use a highly effective contraceptive method during and for 6 months after completion of chemotherapy.

-HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

-Pathologic high-risk factors on diagnostic biopsy: high histologic grade (poorly differentiated), mucinous or signet ring histology, lymphatic/vascular or perineural invasion.

-You must not have visible pelvic sidewall nodes on MRI.

-You must not have previous pelvic radiation for any reason, including brachytherapy alone.

-You must not have had primary lesion excised prior to enrollment.

-You must not have a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

Please read the information below and ask questions about anything that you do not understand. A
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You are being asked to participate in a clinical research potential participant database to identify
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time. If you decide to withdraw from this database you should notify the research team
immediately.

You are eligible to participate in this study if you may be interested in participating in a research trial at UCI Health

We would like to interview you to learn more about your eligibility for current clinical research studies at UCI. The interview will last about 5-30 minutes, depending on the extent of your medical history.

Possible risks/discomforts associated with the database are hearing about potential clinical research studies that may not be of interest to you, invasion of your privacy, or a potential breach of confidentiality.

There are no direct benefits from participation in the database. However, this database may help inform you on clinical research studies that you may be eligible for. Participation in UCI clinical research studies help us gain important data and knowledge that may lead to improved treatment options for people with similar conditions to you in the future.

There are no alternative procedures available. The only alternative is not to participate in this study.

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The research team, authorized UCI personnel, and regulatory entities, may have access to your study records to protect your safety and welfare.

While the research team will make every effort to keep your personal information confidential, it is possible that an unauthorized person might see it. We cannot guarantee total privacy.

Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your information, we may share them with other researchers so they can use them for other studies in the future. We will not share your name or any other private identifiable information that would let the researchers know who you are. We will not ask you for additional permission to share this de-identified information

Data Retention - In accordance with UC Office of the President policy, information will be retained for 10 years after the end of the calendar year in which the research is completed.

If, during the course of this study, significant new information becomes available that may relate to your willingness to continue to participate, this information will be provided to you by the research team listed at the top of the form.

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