NCT03297710

TAS-102 and Radiation Therapy in Treating Patients With Rectal Cancer That Is Locally Recurrent, Metastatic, or Cannot Be Removed by Surgery

Phase I Trial of TAS-102 and Concurrent Radiation Therapy for Patients With Locally Recurrent, Unresectable or Metastatic, Rectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) when given together with radiation therapy in treating patients with rectal cancer that has come back, spread to other places in the body, or cannot be removed by surgery. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving TAS-102 with radiation therapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose and dose-limiting toxicity of TAS-102 when administered in combination with concurrent radiation therapy in patients with locally recurrent or metastatic rectal cancer. SECONDARY OBJECTIVES: I. To determine the overall response rate (ORR) to concurrent TAS-102 and radiation therapy in patients with locally recurrent or metastatic rectal cancer. II. To determine the progression-free survival (PFS) in patients with locally recurrent or metastatic rectal cancer who receive concurrent TAS-102 and radiation therapy. III. To determine the overall survival (OS) in patients with locally recurrent or metastatic rectal cancer who receive combined TAS-102 and radiation therapy. IV. To determine quality of life (QoL) among patients with locally recurrent or metastatic rectal cancer who receive concurrent TAS-102 and radiation therapy. V. To determine the number of patients who are able to undergo surgical resection following concurrent treatment with TAS-102 and radiation therapy. Of this subset of patients, the investigators will assess rates of pathologic complete response (pCR), tumor regression grade (TRG) and rates of R0 resection. OUTLINE: This is a dose-escalation study of trifluridine/tipiracil hydrochloride combination agent TAS-102. Patients receive trifluridine/tipiracil hydrochloride combination agent TAS-102 orally (PO) twice daily (BID) and undergo radiation therapy in 10 fractions on days 1-5 and 8-12 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4-6 weeks, and at 3 and 6 months.

Conditions

• Rectal Adenocarcinoma
• Recurrent Rectal Carcinoma
• Stage IV Rectal Cancer AJCC v7
• Stage IVA Rectal Cancer AJCC v7
• Stage IVB Rectal Cancer AJCC v7

Interventions

Type	Name	Description
OTHER	Quality-of-Life Assessment	Ancillary studies
RADIATION	Radiation Therapy	Undergo radiation therapy
DRUG	Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102	Given PO

Timeline

• Start date: 2017-12-11
• Primary completion: 2020-03-16
• Completion: 2021-04-30
• First posted: 2017-09-29
• Last updated: 2023-01-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study