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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04417699
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : December 15, 2022
Sponsor:
Collaborator:
Taiho Oncology
Information provided by (Responsible Party):
Providence Health & Services

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: TAS 102 Drug: Oxaliplatin Phase 2

Detailed 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
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

Drug: Oxaliplatin
Administered by intravenous infusion over 2 hours on day 1
Other Name: Eloxatin


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of at least 18 years.
  2. Newly diagnosis of rectal adenocarcinoma.
  3. ECOG Performance Status (PS): 0, 1 or 2.
  4. Candidate for sphincter-sparing surgical resection prior to initiation of neoadjuvant therapy according to the primary surgeon.
  5. Clinical Stage: T1/N1, T2/N1, T3/N1, T3c/dN0.

  6. 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.

  7. 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

  8. 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:

  1. Clinical T4 tumors.
  2. Clinical N2 disease estimated as four or more lymph nodes that are ≥8 mm.
  3. Primary surgeon indicates need for abdominoperineal (APR) at baseline.

  4. 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.

  5. Tumor is causing symptomatic bowel obstruction or patients who have had a temporary diverting ostomy are ineligible.
  6. Chemotherapy within 5 years prior to registration. (Hormonal therapy is allowable if the disease free interval is ≥ 5 years.)
  7. Any prior pelvic radiation.

  8. 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mary McCormick, RN 5032159570 mary.mccormick@providence.org

Locations
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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    jzell@uci.edu   
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    mary.mccormick@providence.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         
Sponsors and Collaborators
Providence Health & Services
Taiho Oncology
Investigators
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Principal Investigator: Hagen Kennecke, MD Providence Health & Services
More Information
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT04417699    
Other Study ID Numbers: 2021000326
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: December 15, 2022
Last Verified: December 2022

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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
Keywords provided by Providence Health & Services:
SHORT
short course radiation,
TASOX
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents