Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer (NCT04380337) | Clinical Trial Compass
CompletedPhase 2
Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer
United States38 participantsStarted 2020-05-21
Plain-language summary
The purpose of the research is to evaluate whether both chemotherapy and radiotherapy can lead to higher rates of clinical complete response leading to organ preservation in human subjects with cancer. The objective is to learn if this treatment approach may safely be used as an alternative to the standard treatment for rectal cancer and to know the quality-of-life in these patients.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of rectum requiring total mesorectal excision as deemed by multidisciplinary evaluation
* 2.At least 18 years of age
* 3.For women of childbearing potential or who are not postmenopausal (see Appendix B for Definition of Menopausal Status), a negative urine or serum pregnancy test must be done. Also, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and for up to 4 weeks following the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* 4.ECOG 0, 1, or 2
* 5.Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
* 6.Patients must have acceptable organ and marrow function as defined below:
* Absolute neutrophil count (ANC) \>1,500/uL
* Hg \> 8.0 g/dL; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion
* Platelets \>100,000/uL
* Total bilirubin \<1.5X normal institutional limits
* aspartate aminotransferase (AST) (SGOT) / alanine aminotransferase (ALT)(SGPT) \< 3X upper limit of normal
* Creatinine \<1.5X upper limit of normal or creatinine clearance (CrCL)\>50 by Cockcroft-Gaul…
What they're measuring
1
Clinical Complete Response (cCR)
Timeframe: 8 (+/-4 ) weeks following completion of RT and chemotherapy, an average of 9 months