Rectal Adenocarcinoma Clinical Trial
Official title:
Phase I Trial of TAS-102 and Concurrent Radiation Therapy for Patients With Locally Recurrent, Unresectable or Metastatic, Rectal Cancer
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.
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. ;
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 |