Total Neoadjuvant Therapy in Rectal Cancer

Status Recruiting

Clinical Trial Summary

In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.

Clinical Trial Description

This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is planned to start after the approval by IRB, enroll patients for 2 years, and follow the clinical outcome for another 5 years. It will be conducted at National Cheng Kung University Hospital. Forty-two subjects will be enrolled. Patients who have newly diagnosed stage II or III, middle or low rectal adenocarcinoma will be recruited to receive the TNT treatment. The TNT includes the short-course radiotherapy (5×5 Gy over a maximum of 8 days)) followed by chemotherapy with the regimen of mFOLFOX6 for total 9 cycles ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06162650
Study type	Interventional
Source	National Cheng-Kung University Hospital
Contact	Yu-Min Yeh, MD
Phone	+886 353535
Email	i5485111@gmail.com
Status	Recruiting
Phase	Phase 2
Start date	November 16, 2023
Completion date	November 16, 2030

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06380101` - Evaluating a Nonessential Amino Acid Restriction (NEAAR) Medical Food With Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer (LARC)	N/A
Active, not recruiting	`NCT05551052` - CRC Detection Reliable Assessment With Blood
Recruiting	`NCT04323722` - Impact of Bladder Depletion on Mesorectal Movements During Radiotherapy in Rectal Cancer	N/A
Recruiting	`NCT06006390` - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors	Phase 1/Phase 2
Active, not recruiting	`NCT04088955` - A Digimed Oncology PharmacoTherapy Registry
Active, not recruiting	`NCT01347697` - Collagen Implant (Biological Mesh) Versus GM Flap for Reconstruction of Pelvic Floor After ELAPE in Rectal Cancer	N/A
Recruiting	`NCT04495088` - Preoperative FOLFOX Versus Postoperative Risk-adapted Chemotherapy in Patients With Locally Advanced Rectal Cancer	Phase 3
Withdrawn	`NCT03007771` - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia	Phase 1
Terminated	`NCT01347645` - Irinotecan Plus E7820 Versus FOLFIRI in Second-Line Therapy in Patients With Locally Advanced or Metastatic Colon or Rectal Cancer	Phase 1/Phase 2
Not yet recruiting	`NCT03520088` - PROSPECTIVE CONTROLLED AND RANDOMIZED STUDY OF THE GENITOURINARY FUNCTION AFTER RECTAL CANCER SURGERY IN RELATION TO THE DISSECTION OF THE INFERIOR MESENTERIC VESSELS	N/A
Recruiting	`NCT05556473` - F-Tryptophan PET/CT in Human Cancers	Phase 1
Recruiting	`NCT04749381` - The Role of TCM on ERAS of Rectal Cancer Patients	Phase 2
Enrolling by invitation	`NCT05028192` - Mitochondria Preservation by Exercise Training: a Targeted Therapy for Cancer and Chemotherapy-induced Cachexia
Recruiting	`NCT03283540` - Transanal Total Mesorectal Excision for Rectal Cancer on Anal Physiology + Fecal Incontinence
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A
Recruiting	`NCT05914766` - An Informational and Supportive Care Intervention for Patients With Locally Advanced Rectal Cancer	N/A
Recruiting	`NCT04852653` - A Prospective Feasibility Study Evaluating Extracellular Vesicles Obtained by Liquid Biopsy for Neoadjuvant Treatment Response Assessment in Rectal Cancer
Recruiting	`NCT03190941` - Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients	Phase 1/Phase 2
Completed	`NCT02810652` - Perioperative Geriatrics Intervention for Older Cancer Patients Undergoing Surgical Resection	N/A
Terminated	`NCT02933944` - Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer	Phase 1