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New treatment option for Rectal Adenocarcinoma
Official title MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer
ClinicalTrials.gov ID: NCT04808323
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily, being studied as a potential treatment for rectal adenocarcinoma.
Also referred to as Xeloda.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective, open-label, phase I design.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18.
- 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...
- Eastern Cooperative Oncology Group (ECOG) status 0-2 within 45 days of study entry.
You likely can't join if
- 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...
- 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...
- Severe, active comorbidity, defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last six months.
See the full eligibility criteria
- Age ≥ 18.
- 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- Participation in another treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.