Clinical trials: Total Neoadjuvant Treatment
Rectal Cancer
Organ Preservation Following Enverolimab-based Total Neoadjuvant Therapy for Locally Advanced Very Low Rectal Cancer
Patients diagnosed with locally advanced very low rectal cancer were chosen to participate in a comprehensive neoadjuvant therapy (TNT) protocol.
- Trial name
- TRACE-LE (NCT05969847)
- Testing
- split-course hypofraction radiotherapy, CAPOX, Envafolimab
- Where
- China
- Volunteers
- 72 people
- Sponsor
- 池畔
Efficacy and Safety of Short-course Radiotherapy in Total Neoadjuvant Therapy Combined With Enlonstobart for pMMR Locally Advanced Rectal Cancer
Short-course Radiotherapy in TNT Combined With Enlonstobart for pMMR LARC
Efficacy and safety of short-course radiotherapy in total neoadjuvant therapy combined with enlonstobart for pMMR locally advanced rectal cancer
- Trial name
- NCT07448077
- Testing
- Experimental: short-course radiotherapy and immunotherapy, Chemoradiotherapy
- Where
- China
- Volunteers
- 128 people
- Sponsor
- Hebei Medical University Fourth Hospital
Rectal Adenocarcinoma
Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer
A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer.
- Trial name
- SCRIPBOT (NCT06872606)
- Testing
- Pucotenlimab, Bevacizumab, Oxaliplatin
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Sir Run Run Shaw Hospital
Locally Advanced Rectal Cancer (LARC)
AI-Based Prediction of Pathological Response in Rectal Cancer Patients Receiving Total Neoadjuvant Therapy
This study aims to better understand how body composition, inflammation, and nutrition affect how rectal cancer responds to treatment.
- Trial name
- CINR-AI (NCT07049627)
- Testing
- Total Neoadjuvant Therapy (TNT)
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 93 people
- Sponsor
- Ankara Etlik City Hospital
Rectal Cancer, Rectal Cancer Stage II
ctDNA Monitoring to Predict the Efficacy of TNT for Rectal Cancer
This is a prospective observational study with three primary objectives: Objective 1: Evaluate the detection rate and changes in circulating tumor DNA (ctDNA) levels in blood samples from colorectal cancer patients before…
- Conditions
- Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III
- Trial name
- NCT06589388
- Where
- Vietnam
- Volunteers
- 100 people
- Sponsor
- Gene Solutions
Locally Advanced Rectal Cancer
Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer
Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.
- Trial name
- AXEBEAM (NCT00828672)
- Testing
- Oxaliplatin, Bevacizumab, Capecitabine
- Where
- 9 sites in Belgium
- Volunteers
- 84 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Rectal Cancer
Total Neoadjuvant Therapy Versus Standard Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
The National Comprehensive Cancer Network (NCCN) guidelines recommend trimodality treatment for patients with middle and low LARC with neoadjuvant chemoradiotherapy (NA-CRT), surgical resection with TME, plus additional…
- Trial name
- NCT05274945
- Testing
- Radiotherapy, consolidation chemotherapy, TME or APR
- Where
- Egypt
- Volunteers
- 58 people
- Sponsor
- Alexandria University
Locally Advanced Rectal Cancer
ONCO-RET: Supervised Resistance Training During Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Colorectal cancer is a major cause of cancer death in Chile. Many people with rectal cancer that has grown into nearby tissues receive chemotherapy and radiation before surgery.
- Trial name
- ONCO-RET (NCT07453173)
- Testing
- Strength training program
- Where
- Chile
- Volunteers
- 15 people
- Sponsor
- Fundacion Arturo Lopez Perez
Rectal Malignant Neoplasms
Iparomlimab/Tuvonralimab Integrating With Total Neoadjuvant Therapy for pMMR/MSS Locally Advanced Rectal Cancer (IT-TNT)
In colorectal cancer (CRC), ICIs show strong therapeutic associations with microsatellite instability-high (MSI-H) status, while patients with proficient mismatch repair/microsatellite stable (pMMR/MSS) tumors exhibit poor…
- Trial name
- NCT07026422
- Testing
- Total neoadjuvant therapy integrating iparomlimab/tuvonralimab with chemoradiotherapy
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Shandong Cancer Hospital and Institute
Gastric Cancer
Total Neoadjuvant Therapy With Short Course Radiation Therapy in Gastric Cancer
Standard treatment for patients with early stage gastric cancer consists of perioperative chemotherapy and surgical resection. If radiation therapy is administered in the adjuvant setting, the radiated area is often large and…
- Trial name
- TNT-SHORT (NCT07101666)
- Testing
- Short course radiation therapy, Standard of care neoadjuvant chemotherapy
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Rectum Cancer
Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer
Aim: To investigate the safety and efficacy of organ preservation (OP) with watch-and-wait strategy (W\&W) or local excision (LE) in MRI stratified low-risk rectal cancer treated by total neoadjuvant treatment.
- Trial name
- BJCC-R01 (NCT04405206)
- Testing
- Oxaliplatin, Capecitabine, intensity modulated radiotherapy
- Where
- China
- Volunteers
- 54 people
- Sponsor
- Peking University Cancer Hospital & Institute
Rectal Cancer
A Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
A Phase II Study of Total Neoadjuvant Therapy for High-risk Locally Advanced Rectal Cancer
- Trial name
- NCT04543695
- Testing
- Concurrent Chemoradiotherapy, XELOX, mFOLFOX
- Where
- China
- Volunteers
- 255 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Rectal Cancer, Pathological Complete Response
Effect of Concurrent Capecitabine-based Long-term Radiotherapy Followed by XELOX Plus TME in Patients With High Risk Rectal Cancer: a Multi-centers, Randomized Controlled, Open-Label Trial
The purpose of this study was to evaluate the effect of concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX pre- a delayed TME compared with 6 cycles XELOX post- a Regular Timing TME in patients with…
- Conditions
- Rectal Cancer, Pathological Complete Response, Disease Free Survival
- Trial name
- EXPLORE (NCT03038256)
- Testing
- concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME, concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX
- Where
- 2 sites in China
- Volunteers
- 244 people
- Sponsor
- Peking University People's Hospital
Rectal Cancer, Total Neoadjuvant Treatment
Total Neoadjuvant Therapy and Organ Preservation Versus Surgery for Rectal Cancer.
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT).
- Conditions
- Rectal Cancer, Total Neoadjuvant Treatment, Neoadjuvant Therapy, Radiotherapy
- Trial name
- NCT06758830
- Testing
- Radiation Therapy, Chemoradiotherapy, Consolidation Chemotherapy
- Where
- Lithuania
- Volunteers
- 400 people
- Sponsor
- National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Locally Advanced Rectal Cancer (LARC)
Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer.
This prospective, multi-center, phase II randomized controlled trial will evaluate the actual benefit of adding immunotherapy with tislelizumab to the currently most effective approach against LARC, namely TNT.
- Trial name
- TOTAL (NCT06940388)
- Testing
- Tislelizumab, Total neoadjuvant therapy (TNT)
- Where
- 2 sites in Germany, Israel
- Volunteers
- 134 people
- Sponsor
- brenner baruch
Rectal Cancer
Quality of Life in Patients With Rectal Cancer Receiving Total Mesorectal Excision With or Without Stoma
The goal is to evaluate whether the renunciation of a diverting stoma in patients with adjuvant chemotherapy after low anterior resection with total mesorectal excision (TME) and neoadjuvant chemoradiotherapy leads to a better…
- Trial name
- NCT03487484
- Testing
- Quality of Life Questionnaire for gastrointestinal tract, Quality of Life Questionnaire, Faecal Incontinence Score
- Where
- Switzerland
- Volunteers
- 5 people
- Sponsor
- University Hospital, Basel, Switzerland
Rectal Cancer Patients, Total Neoadjuvant Therapy
Nodal Downstaging Versus Primary Tumor Regression as Predictors of Survival After Total Neoadjuvant Therapy for Rectal Cancer: A Retrospective Study
To evaluate the prognostic impact of post-TNT pathological nodal status (ypN) on LRFS, DMFS, and OS, and compare it with that of primary tumor response
- Trial name
- NCT07557316
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Sohag University
Rectal Cancer
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).
- Trial name
- TNT-RECORD (NCT05883800)
- Testing
- On-couch adaptive radiotherapy
- Where
- Norway
- Volunteers
- 61 people
- Sponsor
- Haukeland University Hospital
Plasma Cell Leukemia in Remission, Plasma Cell Myeloma
Melphalan, Total Marrow Irradiation, and Autologous Stem Cell Transplantation in Treating Patients With High-Risk Multiple Myeloma
This phase I/II trial studies the side effects and best dose of melphalan and total marrow irradiation and how well they work with autologous stem cell transplantation in treating patients with high-risk multiple myeloma.
- Trial name
- NCT03100877
- Testing
- Autologous Hematopoietic Stem Cell Transplantation, Cyclophosphamide, Filgrastim
- Where
- United States
- Sponsor
- City of Hope Medical Center
Colo-rectal Cancer
Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer
NO-CUT is a one-stage phase II trial seeking to establish whether an oxaliplatin-based chemotherapy preceding standard neo-adjuvant fluoropyrimidines-based chemo radiotherapy, can safely spare demolitive surgical intervention in…
- Trial name
- NO-CUT (NCT03565029)
- Testing
- XELOX, Radiotherapy
- Where
- Italy
- Volunteers
- 180 people
- Sponsor
- Niguarda Hospital