SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer (SHORT)

STATUS

Recruiting
End date

Apr 29, 2025
participants needed

27
sponsor

Providence Health & Services

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Updated on 4 October 2022

See if I qualify

metastasis

oxaliplatin

pelvic mri

tas-102

adenocarcinoma

adenocarcinoma of rectum

total mesorectal excision

Summary

TASOX can be safely and efficaciously delivered after short course radiation, resulting in significant pathologic downstaging, allowing for an R0 pelvic resection, and providing local control in appropriately selected stage II/III rectal cancer patients treated with contemporary TME-based surgery.

Description

In this phase II study patients will be treated with short-course preoperative irradiation (25 Gy in five fractions of 5 Gy) followed by 6 (six) 2-week cycles of TASOX followed by total mesorectal excision (TME) for patients with resectable rectal cancer (clinical T3c/dN0, T3c/dN1, T2N1). Eligible study subjects include adults who are candidates for curative intent sphincter-sparing surgery and lack high risk features such as tumor encroaching upon the mesorectal-fascia or low tumors who need an Abdominal-Perineal Resection (APR).

Details

Condition	Rectal Cancer
Treatment	Oxaliplatin, TAS 102
Clinical Study Identifier	NCT04417699
Sponsor	Providence Health & Services
Last Modified on	4 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age of at least 18 years
	Newly diagnosis of rectal adenocarcinoma
	ECOG Performance Status (PS): 0, 1 or 2
	Candidate for sphincter-sparing surgical resection prior to initiation of neoadjuvant therapy according to the primary surgeon
	Clinical Stage: T1/N1, T2/N1, T3/N1, T3c/dN0
	Absence of metastatic disease. Clinical staging is based on physical exam by the primary surgeon, CT scan of the chest/abdomen, and pelvic MRI
	Node positivity determination: Entry criteria nodes will be measured in short-
	axis diameter and for the purposes of study entry will be considered positive
	if 8 mm or greater in short axis
	Radiographic N2 status is estimated as: 4 or more nodes that measure 8mm or
	more in short-axis
	Radiographic N1 status is estimated as: fewer than 4 lymph nodes that measure
	mm or greater in short axis but 1 or more lymph nodes that measure 8 mm or
	greater
	Nodal Metastatic Disease: nodal stations considered suspicious for metastatic
	disease (M1) for rectal cancer are common iliac, external iliac and inguinal
	nodes
	No evidence of tumor that is adherent to the mesorectal fascia and the ability to perform a curative intent sphincter-sparing TME resection at diagnosis. See exclusion criterion 4
	The following laboratory values obtained ≤ 28 days prior to registration
	Platelet count ≥ 100,000/mm^3
	Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
	SGOT (AST) ≤ 3 x ULN
	Hemoglobin > 8.0 g/dL
	SGPT (ALT) ≤ 3 x ULN
	Creatinine ≤1.5 x ULN
	Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing
	potential only
	A patient of child-bearing potential is willing to employ adequate contraception. It includes any of the followings: abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). See exclusion criterion 8
	Provide informed written consent
	Willing to return to enrolling medical site for all study assessments
Exclusion Criteria
	Clinical T4 tumors
	Primary surgeon indicates need for abdominoperineal (APR) at baseline
	Evidence that the tumor is adherent to or invading the mesorectal fascia on imaging studies such that the surgeon would not be able to perform an R0 resection (one with negative margins)
	Clinical N2 disease estimated as four or more lymph nodes that are ≥8 mm
	Distance of the Tumor from the Mesorectal Fascia
	Patients with tumors with a distance of 1mm or less from the mesorectal fascia
	reflection have threatened radial margins and are ineligible
	Tumor is causing symptomatic bowel obstruction or patients who have had a temporary diverting ostomy are ineligible
	Chemotherapy within 5 years prior to registration. (Hormonal therapy is allowable if the disease free interval is ≥ 5 years.)
	Any prior pelvic radiation
	Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects
	Pregnant women
	Nursing women
	Men or women of childbearing potential who are unwilling to employ adequate contraception
	Co-morbid illnesses or other concurrent disease which, in the judgment of the treating
	investigator obtaining informed consent, would make the patient inappropriate
	for entry into this study or interfere significantly with the proper
	assessment of safety and toxicity of the prescribed regimens

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SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer (SHORT)