Is NCT04808323 recruiting in Milwaukee, WI?

Yes, NCT04808323 is currently recruiting participants at its Milwaukee, WI location. This rectal adenocarcinoma clinical trial is actively enrolling qualified participants.

How do I join the rectal adenocarcinoma clinical trial in Milwaukee?

To join this clinical trial in Milwaukee, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Milwaukee clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Rectal Adenocarcinoma Clinical Trial in Milwaukee, WI

Who Can Participate

Inclusion Criteria

Pathologically confirmed (histologic or cytological), adenocarcinoma of the rectum.

Determined on staging evaluation to be clinical stage I, II or III.

No concerning unequivocal or biopsy-proven metastatic disease. Patients are eligible with either no evidence of distant metastatic disease, or "equivocal" evidence of distant metastatic disease, as judged by the multidisciplinary tumor board. This "equivocal" definition can include small lung or liver lesions that are not able to be radiographically characterized otherwise.

Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.

History/physical examination, including collection of weight and vital signs within 45 days prior to start of treatment.

MR of the rectum is mandatory for staging and follow-up.

Chest CT scan within 45 days prior to study entry.

Radiation treatment planning abdominal CT. A mandatory pelvic MR will be done as a simulation (SIM) (ideally with interpretation). The CT SIM will not be done with interpretation. Ability to undergo abdominal MR scans for staging and radiation planning and follow-up is mandatory.

Laboratory values (CBC, Chem24) 45 days prior to treatment as follows:

Carcinoembryonic antigen (CEA) (any value).

Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3.

Platelets ≥50,000 cells/mm3.

Hemoglobin ≥ 8.0 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal.

Total bilirubin \< 2 x upper normal mg/dL.

Alkaline phosphatase \< 4 x upper limit of normal.

Not on hemodialysis.

Ability to swallow oral medications.

Patients must be determined by medical oncology to be a candidate for systemic chemotherapy.

Patients must provide study-specific informed consent prior to study entry.

Negative serum pregnancy test (if applicable).

Women of childbearing potential and male participants who are sexually active must practice adequate contraception.

Exclusion Criteria

Biopsy-proven distant metastatic disease or high clinical concern for metastatic disease and tumor conference consensus of stage IV disease.

Prior invasive malignancy (except nonmelanomatous skin cancer, noninvasive breast cancer (DCIS), or prostate cancer under active surveillance). Other malignancies are allowed if patient has been disease free for a minimum of three years

Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.

Any major surgery within 28 days prior to study entry, except colonic stent placement, intestinal diversion without resection or vascular access insertion.

Severe, active comorbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.

Transmural myocardial infarction within three months prior to study entry.

Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration.

Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration.

Uncontrolled malabsorption syndrome significantly affecting gastrointestinal function.

Any unresolved intestinal obstruction.

Acquired immune deficiency syndrome (AIDS), based upon current Centers for Disease Control and Prevention (CDC) definition. Note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because patients receiving antiretroviral therapy may experience possible pharmacokinetic interactions with required treatment medications, such as capecitabine.

Absence of any significant medical comorbidity which would preclude the consideration of major intestinal surgery.

Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during the course of the study and for women three months after study therapy is completed and for men six months after study therapy is completed. This exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Participation in another interventional clinical treatment trial while on study (observational trials are permitted).

Patients taking nonprotocol-specified chemotherapy agents or immune-modulating agents for other medical conditions are not permitted to participate in this trial. Any medication questions should be reviewed by the PI.

Poor functional status such that patients are not able to be positioned for radiation treatments.

Gadolium allergy.

If age over 60, history of hypertension, diabetes or liver transplant, and glomerular filtration rate (GFR) at enrollment is \< 30.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Milwaukee?

Yes, this clinical trial (NCT04808323) has an active research site in Milwaukee, WI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Rectal Adenocarcinoma Treatment Options in Milwaukee, WI

If you're searching for rectal adenocarcinoma treatment options in Milwaukee, WI, this clinical trial (NCT04808323) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Milwaukee research site is actively enrolling participants for this clinical trial. You'll receive care from experienced rectal adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all rectal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

Rectal Adenocarcinoma Clinical Trial in Milwaukee, WI

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About This Rectal Adenocarcinoma Study in Milwaukee