SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer (SHORT)
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|ClinicalTrials.gov Identifier: NCT04417699|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : December 15, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Drug: TAS 102 Drug: Oxaliplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SHORT: SHOrt Course Radiation and TASOX (TAS102 Plus Oxaliplatin) Chemotherapy in Operable Rectal Cancer, a Phase II Trial|
|Actual Study Start Date :||July 5, 2022|
|Estimated Primary Completion Date :||October 2024|
|Estimated Study Completion Date :||April 2025|
Experimental: TAS102 plus Oxaliplatin
Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID
Drug: TAS 102
Oral medication over Days 1-5
Other Name: Tipiracil hydrochloride
Administered by intravenous infusion over 2 hours on day 1
Other Name: Eloxatin
- Achieve a reduction by at least 5.8 in Neoadjuvant Response (NAR) score compared to historic controls with NAR of 14.59 [ Time Frame: Through study completion, an average of 6 months ]determine whether pre-operative short-course radiation therapy (SRT) and 6 cycles of TASOX offers condensed radiation and total neoadjuvant therapy for intermediate risk rectal cancer.
- Safety and Tolerability [ Time Frame: Through study completion, an average of 6 months ]The secondary objective is to describe Incidence of Treatment-Emergent Adverse Events and surgery complications among treated subjects.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 8 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
- 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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417699
|Contact: Mary McCormick, RNfirstname.lastname@example.org|
|United States, California|
|University of California, Irvine||Not yet recruiting|
|Orange, California, United States, 92868|
|Contact: Jason A. Zell, DO, MPH, MS 714-456-5153 email@example.com|
|Principal Investigator: Jason A. Zell, DO, MPH, MS|
|United States, New York|
|Columbia University Irving Medical Center/NYPH||Not yet recruiting|
|New York, New York, United States, 10032|
|Contact: Lisa A. Kachnic, MD|
|Principal Investigator: Lisa A. Kachnic, MD|
|United States, Oregon|
|Providence Portland Medical Center||Recruiting|
|Portland, Oregon, United States, 97213|
|Contact: Mary McCormick, RN 503-215-9570 firstname.lastname@example.org|
|Principal Investigator: Hagen Kennecke, MD|
|United States, Washington|
|Virginia Mason Medical Center||Recruiting|
|Seattle, Washington, United States, 98101|
|Contact: Huong Pham, MD 206-223-6801 Huong.Pham@virginiamason.org|
|Principal Investigator: Huong Pham, MD|
|Principal Investigator:||Hagen Kennecke, MD||Providence Health & Services|
|Responsible Party:||Providence Health & Services|
|Other Study ID Numbers:||
|First Posted:||June 5, 2020 Key Record Dates|
|Last Update Posted:||December 15, 2022|
|Last Verified:||December 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||Yes|
short course radiation,
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases