Short Course Radiation + TASOX for Rectal Cancer

(SHORT Trial)

Recruiting at5 trial locations

Overseen by Hagen Kennecke, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Benaroya Research Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial involves treating adults with stage II/III rectal cancer using a combination of radiation, chemotherapy, and surgery. The radiation helps shrink the tumor, the chemotherapy kills additional cancer cells, and the surgery removes the remaining cancer. This approach aims to allow for effective cancer removal while preserving normal functions.

Research Team

Hagen Kennecke, MD

Principal Investigator

Providence Health & Services

Eligibility Criteria

This trial is for adults over 18 with stage II/III rectal cancer who are candidates for sphincter-sparing surgery and have no metastatic disease. They must not have had chemotherapy in the last 5 years or prior pelvic radiation, and should be able to use contraception if of childbearing potential.

Inclusion Criteria

The following laboratory values obtained ≤ 28 days prior to registration

Platelet count ≥ 100,000/mm^3

Hemoglobin > 8.0 g/dL

Exclusion Criteria

My surgeon has recommended an APR surgery for me.

My tumor is more than 1mm away from the mesorectal fascia.

My cancer is large or has spread to nearby tissues.

Treatment Details

Interventions

• Oxaliplatin (Alkylating agents)
• TAS 102 (Alkylating agents)

Trial Overview The study tests TASOX (TAS102 plus Oxaliplatin) chemotherapy following short course radiation therapy to see if it can safely shrink tumors before surgery, allowing for complete removal without affecting the anal sphincter in rectal cancer patients.

Participant Groups

Group I: TAS102 plus Oxaliplatin Experimental Treatment 2 Interventions

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

Oxaliplatin is already approved in Canada, Japan, Switzerland, China for the following indications:

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

Who Is Running the Clinical Trial?

Benaroya Research Institute

Lead Sponsor

Trials

50

Recruited

12,300+

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

Dr. Laurel Soot

Providence Health & Services

Chief Medical Officer since 2024

MD, FACS

Erik Wexler

Providence Health & Services

Chief Executive Officer

Bachelor's degree in Business Administration from the University of Massachusetts Amherst

Taiho Oncology

Collaborator

Trials

2

Recruited

30+