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

  • STATUS
    Recruiting
  • participants needed
    27
  • sponsor
    Benaroya Research Institute
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Updated on 5 August 2020
See if I qualify
cancer
ct scan
metastasis
oxaliplatin
adenocarcinoma
adjuvant therapy
pelvic mri
rectal carcinoma
chest ct
rectal cancer
tas-102
adenocarcinoma of rectum
mri pelvis

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 Colorectal Cancer, Colorectal Cancer, Rectal Cancer, Rectal Cancer
Age 18years - 100years
Treatment Oxaliplatin, TAS 102
Clinical Study IdentifierNCT04417699
SponsorBenaroya Research Institute
Last Modified on5 August 2020

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
Hemoglobin > 8.0 g/dL
Total bilirubin 1.5 x upper limit of normal (ULN)
SGOT (AST) 3 x ULN
SGPT (ALT) 3 x ULN
Creatinine 1.5 x ULN 9\. Negative pregnancy test done 7 days prior to registration, for women of childbearing potential only. 10\. 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 11\. Provide informed written consent. 12\. Willing to return to enrolling medical site for all study assessments

Exclusion Criteria

Clinical T4 tumors
Clinical N2 disease estimated as four or more lymph nodes that are 8 mm
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)
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 9\. 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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