Clinical trials: Total Neoadjuvant Therapy
Locally Advanced Rectal Cancer, Rectal Adenocarcinoma
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
This prospective national multicentre feasibility study evaluates dose-escalated short-course proton radiotherapy followed by total neoadjuvant chemotherapy in patients with primary high-risk locally advanced rectal…
- Trial name
- PROSPECT-WW (NCT07903883)
- Testing
- Intensity modulated proton therapy
- Where
- 8 sites in Denmark
- Volunteers
- 30 people
- Sponsor
- University of Aarhus
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
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
Colorectal Cancer
Total Neoadjuvant Treatment for pMMR Locally Advanced Low Rectal Cancer: Anti-PD-1 Antibody With FOLFOXIRI and Preoperative Radiation Therapy
For locally advanced rectal cancer, the initial goal of neoadjuvant chemoradiotherapy is to reduce local recurrence, but the pathologic complete response (PCR) rate is low, and distant metastasis becomes the main treatment…
- Trial name
- NCT06099951
- Testing
- Serplulimab + FOLFOXIRI, Radiation therapy
- Volunteers
- 53 people
- Sponsor
- Sun Yat-sen University
Locally Advanced Rectal Cancer
TNT of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer
This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
- Trial name
- ENSEMBLE (NCT05646511)
- Testing
- SCRT, CAPOX, CAPOXIRI
- Where
- 34 sites in Japan
- Volunteers
- 608 people
- Sponsor
- National Cancer Center Hospital East
Rectal Cancer
Minimally Invasive Sphincter Sparing Total Mesorectal Excision for Ultra-low Rectal Cancer After Initial Chemo-radiotherapy (MISS-TRICR).
A prospective study is planned for management of low rectal cancer with the aim of sphincter preservation and improving the oncological outcome of the patients, through comparing of both approaches minimally invasive techniques…
- Trial name
- MISS-TRICR (NCT02488707)
- Testing
- laparoscopic intersphincteric resection (LISR group), Transanal minimally invasive Total mesorectal excision (TAMIS group)
- Where
- Egypt
- Volunteers
- 250 people
- Sponsor
- Mansoura University
Pancreatic Ductal Adenocarcinoma
Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
The purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (TNT) in preparation for surgery for participants that have pancreatic ductal adenocarcinoma (PDAC)
- Trial name
- NCT03865875
- Testing
- Exercise Program, Nutrition Program
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Massachusetts General Hospital
Locally Advanced Rectal Carcinoma
Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer
The aim of this clinical trial is to compare triplet induction therapy (FOLFOXIRI) with doublet induction therapy (CAPOX/FOLFOX), followed by chemoradiotherapy and either surgery or a watch-and-wait approach, in patients with…
- Trial name
- MEND-IT II (NCT07472868)
- Testing
- FOLFOXIRI, CAPOX, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
- Where
- 20 sites in Netherlands
- Volunteers
- 394 people
- Sponsor
- J. W. A. Burger
Locally Advanced Rectal Cancer (LARC), MSS (Microsatellite Stable)
SCRT Based iTNT vs. LCRT Based TNT for MSS Locally Advanced Rectal Cancer
In this prospective, multicentre, randomized phase III trial, 612 locally advanced rectal cancer (LARC, T3-4/N+M0) patients with at least one high-risk features (lower location (≤5cm), cT4, cN2, MRF+, EMVI+, TD+) will be…
- Trial name
- TORCH-STAR (NCT07551479)
- Testing
- short-course radiaotherapy, long-course chemoradiaothearpy, Capecitabine
- Where
- China
- Volunteers
- 612 people
- Sponsor
- Fudan University
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
Locally Advanced Gastric Cancer
Proximal Gastrectomy vs Total Gastrectomy in Locally Advanced Upper Gastric Cancer After Neoadjuvant Therapy
We plan to evaluate the efficacy and safety of proximal gastric vs. total gastric radical resection after SOX combined with anti-PD-1 neoadjuvant therapy in locally advanced upper gastric cancer
- Trial name
- TJHGC01 (NCT06597227)
- Testing
- Proximal radical gastrectomy, Total radical gastrectomy
- Where
- China
- Volunteers
- 404 people
- Sponsor
- Guihua Wang
Rectal Neoplasms Malignant, Radiotherapy
Short-course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer
This phase II/III trial studies how well neoadjuvant short-course radiotherapy and chemotherapy with or without PD-1 inhibitors works in treating patients with locally advanced rectal adenocarcinoma.
- Trial name
- NCT05484024
- Testing
- Sintilimab, Short-course radiotherapy, CAPOX/mFOLFOX
- Where
- 2 sites in China
- Volunteers
- 588 people
- Sponsor
- Chinese Academy of Medical Sciences
Colorectal Cancer, Rectal Cancer
Circulating Tumor DNA to Monitor the Efficacy of Total Neoadjuvant Therapy for Rectal Cancer
The purpose of this study is to use the SignateraTm assay created from rectal tumor biopsies to monitor participants' blood for fragments of DNA shed by tumor cells.
- Trial name
- NCT05356585
- Testing
- SignateraTM assay
- Where
- United States
- Sponsor
- Case Comprehensive Cancer Center
Rectal Cancer
Neoadjuvant Chemoradiation With Nal-IRI and Capecitabine Guided by UGT1A1 Status in Patients With Rectal Cancer
This single-arm trial will explore the efficacy and safety of long-course neoadjuvant chemoradiation with liposomal irinotecan and capecitabine guided by UGT1A1 status in patients with locally advanced rectal cancer.
- Trial name
- NCT06210971
- Testing
- liposomal irinotecan, Capecitabine, Radiation threapy
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hebei Medical University Fourth Hospital
Patients With Locally Advanced Rectal Cancer
GEMCAD-REVEAL STUDY - Circulating Tumor DNA as a Predictor of Relapse in Patients With Locally Advanced Rectal Cancer.
The evaluation of the tumor response to chemoradiotherapy/total neoadjuvant therapy (CRT/TNT) remains a challenge. The integration of a blood-based biomarker such as ctDNA with clinico-radiological tools could offer the potential…
- Trial name
- REVEAL (NCT05674422)
- Testing
- total neoadjuvant therapy
- Where
- 15 sites in Spain
- Volunteers
- 120 people
- Sponsor
- Grupo Espanol Multidisciplinario del Cancer Digestivo
Rectal Cancer
Lateral Lymph Node Dissection After Neoadjuvant Chemo-radiation in Advanced Low Rectal Cancer
Lateral lymph nodes (LLD) metastasis is a major cause of local recurrence for advanced rectal cancer. As for the treatment strategies on LLN metastasis, there are huge controversies on whether lateral pelvic lymph nodes…
- Trial name
- NCT02614157
- Testing
- LLND, labeled line
- Where
- China
- Volunteers
- 51 people
- Sponsor
- West China Hospital
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
Trial of the Efficacy and Safety of Short and Long Course Radiation Therapy With/Without BMX-001
In this Phase 2 study, we will conduct an efficacy and safety study of the combination of investigational drug BMX-001, with short-course radiotherapy (SCRT) or long-course chemoradiotherapy (LCCRT) as part of total neoadjuvant…
- Trial name
- NCT05254327
- Testing
- BMX-001
- Where
- 3 sites in United States
- Volunteers
- 118 people
- Sponsor
- University of Nebraska
Locally Advanced Rectal Cancer
Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29
The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.
- Trial name
- ShorTrip (NCT05253846)
- Testing
- Irinotecan, Oxaliplatin, Lederfolin
- Where
- Italy
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Gruppo Oncologico del Nord-Ovest
Rectal Cancer
A Multicenter Single-arm P2 to Evaluate Safety and Efficacy of the Total Neoadjuvant Therapy for cT2 Rectal Cancer
A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal…
- Trial name
- AMBITION (NCT05939661)
- Testing
- Radiation, Chemotherapy, Surgery
- Where
- 2 sites in Japan
- Volunteers
- 45 people
- Sponsor
- Osaka University