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
Updated on 4 October 2022
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 IdentifierNCT04417699
SponsorProvidence Health & Services
Last Modified on4 October 2022

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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