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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 : March 16, 2021
Sponsor:
Collaborator:
Virginia Mason Hospital/Medical Center
Information provided by (Responsible Party):
Benaroya Research Institute

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).

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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 : April 1, 2020
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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

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




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.



Information from the National Library of Medicine

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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.

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: Houng Pham, MD 206-223-6801 Huong.Pham@virginiamason.org

Locations
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United States, New York
Herbert Irving Comprehensive Cancer Center Not yet recruiting
New York, New York, United States, 10032
Contact: Lisa A. Kachnic, MD         
Principal Investigator: Lisa A. Kachnic, 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
Benaroya Research Institute
Virginia Mason Hospital/Medical Center
Investigators
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Principal Investigator: Houng Pham, MD Virginia mason medical Center
Principal Investigator: Lisa A. Kachnic, MD Columbia University
Principal Investigator: Hagen Kennecke, MD Providence Health & Services
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Responsible Party: Benaroya Research Institute
ClinicalTrials.gov Identifier: NCT04417699    
Other Study ID Numbers: CRP18085
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: March 16, 2021
Last Verified: March 2021

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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 Benaroya Research Institute:
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