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

NCT04417699 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2021000326
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

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.

Conditions

Rectal Cancer

Keywords

SHORT; short course radiation,; TASOX

Outcome Measures

Primary Outcomes (1)

• Neoadjuvant Response (NAR) Score

  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. Measurement of efficacy is the NAR score, where the required elements of the NAR score are: clinical tumor stage (cT), pathologic tumor stage (pT), pathological nodal stage (pN). For patients with a cCR who opted for non-operative management, for the purposes of the NAR score, those patients were assigned a pT0 and pN0 score if they did not experience tumor regrowth or require subsequent TME surgical resection during the time of the study. The NAR score ranges from 0-100, where lower NAR scores are considered favorable as opposed to higher scores which would indicate a worse prognosis. NAR calculation as follows: NAR=\[5 pN- 3(cT-pT)+12\]\^2/9.61

  Through study completion, an average of 6 months

Secondary Outcomes (1)

• Safety and Tolerability

  Through study completion, an average of 6 months

Study Arms (1)

TAS102 plus Oxaliplatin

EXPERIMENTAL

Oxaliplatin 85mg/m2 IV over 2 hours and TAS-102 (35 mg/m2/dose) orally BID

Drug: TAS 102; Drug: Oxaliplatin

Interventions

TAS 102 DRUG

Oral medication over Days 1-5

Also known as: Tipiracil hydrochloride

TAS102 plus Oxaliplatin

Oxaliplatin DRUG

Administered by intravenous infusion over 2 hours on day 1

Also known as: Eloxatin

TAS102 plus Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• Taiho Oncology: collaborator

Study Sites (4)

University of California, Irvine

Orange, California, 92868, United States

Location

Columbia University Irving Medical Center/NYPH

New York, New York, 10032, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

trifluridine tipiracil drug combination; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Dr. Hagen Kennecke
• Organization: OHSU Knight-Legacy Health Cancer Collaborative

kennecke@ohsu.edu

971-262-9600

Study Officials

• Hagen Kennecke, MD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: June 5, 2020
• Study Start: July 5, 2022
• Primary Completion: December 14, 2023
• Study Completion: February 21, 2024
• Last Updated: December 10, 2025
• Results First Posted: December 10, 2025

Record last verified: 2025-12

Locations

US (4)