Clinical Trials Logo

Clinical Trial Summary

This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). 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. This study is being done to find out the safest dose of TAS-102 that can be used with radiation treatment for rectal cancer.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To determine the recommended phase 2 dose of trifluridine and tipiracil hydrochloride (TAS-102) per the proportion of grade 3 or higher adverse events during chemo-radiation therapy (CRT) with concurrent TAS-102 at the maximum tolerated dose by allowing no more than 30% grade 3 or higher adverse events. SECONDARY OBJECTIVES: I. Evaluate safety of participants treated with TAS-102 during radiation therapy (RT). II. Evaluate treatment emergent adverse events (TEAEs) attributable to TAS-102 with RT during fluorouracil/leucovorin calcium/oxaliplatin (FOLFOX) or capecitabine/oxaliplatin (CAPOX) treatment. EXPLORATORY OBJECTIVES: I. To preliminary assess the rates of complete clinical response (cCR) by magnetic resonance imaging (MRI) and by endoscopy after TAS-102 with concurrent CRT. II. To preliminary assess the rates of cCR by MRI and by endoscopy after treatment with FOLFOX. III. To preliminary assess the rates of pCR after standard total mesorectal excision (TME). OUTLINE: This is dose-escalation study of TAS-102. Patients receive TAS-102 orally (PO) twice daily (BID) Monday-Friday on weeks 1, 3, and 5. Patients also undergo intensity modulated radiotherapy (IMRT) or 3-dimensional conformal radiotherapy (3D-CRT) 5 days per week on weeks 1-5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care FOLFOX or CAPOX. After completion of study treatment, patients are followed for up to a total of 16 weeks (3 months) from end of FOLFOX or CAPOX treatment until rectal cancer surgery or death, whichever occurs first. Participants that opt for a non-surgical option at the end of chemotherapy may be followed for a longer period of time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04104139
Study type Interventional
Source OHSU Knight Cancer Institute
Contact OHSU Knight Cancer Clinical Trials Hotline
Phone 503-494-1080
Email trials@ohsu.edu
Status Recruiting
Phase Phase 1
Start date December 11, 2019
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05081024 - Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Not yet recruiting NCT04090450 - Optimisation of Radiotherapy in Rectal Cancer (ORREC)
Recruiting NCT06050447 - Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Terminated NCT02233595 - Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Completed NCT02935309 - Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma Phase 1
Terminated NCT01887509 - Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology N/A
Recruiting NCT05746195 - Optimization of Adaptive Text Messages for Cancer Survivors (OATS II) N/A
Active, not recruiting NCT03365882 - S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery Phase 2
Completed NCT02314182 - GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis Phase 3
Completed NCT02393755 - Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT04441580 - Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting N/A
Terminated NCT03527784 - Prestoma-Trial for Parastomal Hernia Prevention N/A
Completed NCT00855946 - Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy N/A
Recruiting NCT06328361 - Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer N/A
Recruiting NCT02107105 - Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
Terminated NCT03300544 - Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer Phase 1
Active, not recruiting NCT03436563 - M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability Phase 1/Phase 2
Not yet recruiting NCT04814784 - Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum
Recruiting NCT05482516 - Evaluating Novel Therapies in ctDNA Positive GI Cancers Phase 3
Completed NCT02368886 - Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2