Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer

STATUS

Recruiting
End date

May 5, 2027
participants needed

37
sponsor

Stanford University

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Updated on 19 February 2024

See if I qualify

cancer

blood transfusion

absolute neutrophil count

serum pregnancy test

metastasis

neutrophil count

adenocarcinoma

folfox regimen

chest ct

rectal cancer

folfoxiri

organ preservation

adenocarcinoma of rectum

total mesorectal excision

xelox

mri pelvis

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.

Description

Primary Objective: To assess clinical complete response of an organ preservation approach using short course radiation followed by intensified chemotherapy.

Secondary Objective: To assess safety in all enrolled patients, local regrowth rate and other cancer specific outcomes (metastasis-free survival, colostomy-free survival and overall survival), longitudinal health-related quality of life of this organ preservation approach

Details

Condition	Colorectal Cancer, Colorectal Cancer, Rectal Cancer, Rectal Cancer
Age	18-100 years
Treatment	IMRT, FOLFOXIRI, FOLFOX regimen, XELOX
Clinical Study Identifier	NCT04380337
Sponsor	Stanford University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically confirmed adenocarcinoma of rectum (non-metastatic, >T2N0 or low T2N0 rectal cancer) not eligible for up-front organ preservation surgery as deemed by multidisciplinary evaluation
	At least 18 years of age
	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
	ECOG 0, 1, or 2
	Ability to understand and the willingness to personally sign the written IRB approved informed consent document
	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-Gault
Exclusion Criteria
	Prior pelvic RT or chemotherapy for rectal cancer
	Upper T2N0 rectal cancers eligible for sphincter-preservation surgery
	Use of other investigational agents
	Ongoing or active infections requiring systemic antibiotic treatment or uncontrolled intercurrent illness including but not limited to symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
	Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. Patients with any previous malignancy without evidence of disease for >3 years will be allowed to enter the trial
	Known hypersensitivity to 5-FU compounds
	Pregnant and breastfeeding women are excluded. Women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study are excluded. (This applies to women who have experienced menarche and have not undergone successful surgical sterilization or are not postmenopausal)
	Because patients with immune deficiency are at increased risk of lethal
	infections when treated with marrow-suppressive therapy, known HIV-positive
	patients with detectable viral loads and/or receiving combination anti-
	retroviral therapy are excluded from the study
	Primary unresectable rectal cancer (tumor invading adjacent organs and en bloc resection will not achieve negative margins)

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Organ Preservation Program Using Short-Course Radiation & FOLFOXIRI in Rectal Cancer