Clinical trials: Total Neoadjuvant Therapy
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 Cancer, Adenocarcinoma, Locally Advanced Malignant Neoplasm
Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer
The benefit of aspirin in cancer of the colon and rectum is already known. Recently, it was described its potential activity during chemoradiotherapy, with higher rate of tumor downstaging.
- Conditions
- Rectal Cancer, Adenocarcinoma, Locally Advanced Malignant Neoplasm, Chemoradiation
- Trial name
- ICAR (NCT03170115)
- Testing
- Aspirin
- Where
- Brazil
- Volunteers
- 25 people
- Sponsor
- Instituto Nacional de Cancer, Brazil
Rectal Cancer
Short Course Radiation Therapy Followed by Pre-operative Chemotherapy and Surgery in High-risk Rectal Cancer
Patients with a primary rectal cancer without detectable distant metastasis who after locoregional therapy only, meaning preoperative radio(chemo)therapy plus surgery have at least a 40% risk of not having a CRM negative…
- Trial name
- LARCT-US (NCT03729687)
- Testing
- radiotherapy, capecitabine, oxaliplatin
- Where
- Sweden
- Volunteers
- 280 people
- Sponsor
- Uppsala University
Rectal Neoplasms Malignant
FAPI in Rectal Cancer TNT
The goal of the trial is to observe the changes of 68Ga FAPI signal before and after total neoadjuvant therapy for rectal cancers, and the correlation between the image parameters, immune checkpoints expression as well as the…
- Trial name
- NCT06157463
- Testing
- Ga-68 FAPI
- Where
- Taiwan
- Volunteers
- 99 people
- Sponsor
- Chang Gung Memorial Hospital
Rectal Cancer, Rectal Cancer Stage II
TNT to Increase the Clinical Complete Response Rate for Distal LARC
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.
- Conditions
- Rectal Cancer, Rectal Cancer Stage II, Rectal Cancer Stage III, Chemoradiation
- Trial name
- TESS (NCT03840239)
- Testing
- Capecitabine, Oxaliplatin, External beam radiotherapy, Surgery
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Sun Yat-sen University
Rectal Cancer, Total Neoadjuvant Treatment
Short-course Radiotherapy With Induction and Consolidation Chemotherapy in Patients With Locally Advanced Rectal Cancer
Short-course radiotherapy followed by consolidation chemotherapy has shown a better response rate when compared to chemoradiotherapy treatment.
- Trial name
- SHORT-ICAR (NCT04674696)
- Testing
- Approach
- Where
- Brazil
- Volunteers
- 54 people
- Sponsor
- Instituto Nacional de Cancer, Brazil
Rectal Neoplasms, Rectal Neoplasm Malignant
A Safety Study Adding Niraparib and Dostarlimab to Radiation Therapy for Rectal Cancers
This clinical trial is designed to determine the maximum tolerated dose of niraparib when combined with dostarlimab and hypofractionated radiation for locally advanced rectal cancer.
- Trial name
- NCT04926324
- Testing
- Niraparib, Dostarlimab, Short course radiation
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Iowa
Locally Advanced Rectal Cancer
Gut Microbiome and Its Immune Modulation in Locally Advanced Rectal Cancer
To investigate dynamic change of gut microbiomes and metabolites, and their effects on immune modulation. To evaluate the efficacy and safety of TNT with GEN-001 (Lactococcus lactis) and identify predictive biomarkers for…
- Trial name
- NCT05079503
- Testing
- GEN-001
- Volunteers
- 40 people
- Sponsor
- Korean Cancer Study Group
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
Local Excision in Downstaged Rectal Cancer
Patients with T2T3 low rectal cancer (size =< 4 cm) received neoadjuvant treatment (50Gy in 5 weeks with concomitant chemotherapy.
- Trial name
- GRECCAR 2 (NCT00427375)
- Testing
- local rectal excision, total mesorectal excision
- Where
- 40 sites in France
- Volunteers
- 148 people
- Sponsor
- University Hospital, Bordeaux
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
Rectal Cancer
Neoadjuvant Chemoradiotherapy Versus Total Neoadjuvant Therapy in the Treatment of T3 Rectal Cancer
The gold standard treatment for locally advanced, non-metastatic rectal cancer includes neoadjuvant chemoradiotherapy (NACRT), total mesorectal excision (TME) and adjuvant chemotherapy (AC).
- Trial name
- NCT06097416
- Testing
- Neoadjuvant Chemoradiotherapy, Total Neoadjuvant Therapy
- Volunteers
- 100 people
- Sponsor
- St. James's Hospital, Ireland
Locally Advanced Rectal Carcinoma
Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer
Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones.
- Trial name
- TEHRAN (NCT05920928)
- Testing
- Short course radiotherapy with concurrent capecitabine(825mg/m2), Long course radiotherapy with concurrent capecitabine(825mg/m2)
- Volunteers
- 114 people
- Sponsor
- Tehran University of Medical Sciences
Locally Advanced Rectal Adenocarcinoma
Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old
The primary objective of the NACRE-2 trial is to assess whether the addition of chemotherapy after short-course radiotherapy is more effective than short-course radiotherapy alone in elderly patients with locally advanced rectal…
- Trial name
- NACRE-2 (NCT07118800)
- Testing
- FOLFOX4s, Short Course Radiotherapy
- Volunteers
- 160 people
- Sponsor
- UNICANCER
Rectal Cancer
Durvalumab (MEDI4736) Plus Total Neoadjuvant Therapy (TNT) in Locally Advanced Rectal Cancer
The addition of durvalumab to total neoadjuvant therapy (TNT) in locally advanced rectal cancer may improve the pathological complete response rate.
- Trial name
- DUREC (NCT04293419)
- Testing
- Durvalumab (MEDI4736)
- Where
- 10 sites in Spain
- Volunteers
- 58 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, Older People
Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal…
- Trial name
- SHAPERS (NCT06052332)
- Testing
- Short course radiotherapy, Adjuvant chemotherapy (optional), Total mesorectal excision
- Where
- 19 sites in Belgium
- Volunteers
- 230 people
- Sponsor
- Jules Bordet Institute
Rectal Cancer, Adenocarcinoma
SCRT-NALIRIXELOX+Sintilimab as TNT for High-Risk LARC
This is a single-center, exploratory clinical study for patients with newly diagnosed, high-risk, locally advanced rectal cancer.
- Trial name
- NCT07474103
- Testing
- SCRT, Liposomal Irinotecan, Oxaliplatin
- Where
- China
- Volunteers
- 49 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Multiple Myeloma
Total Marrow Irradiation With High Dose Melphalan Prior to Autologous Transplant for Multiple Myeloma
In this phase I trial, patients with multiple myeloma will receive standard high dose melphalan with autologous stem cell rescue. In addition the pre-transplant conditioning will include targeted total marrow irradiation (TMI).
- Trial name
- BMT-02 (NCT02043860)
- Testing
- Total Marrow Irradiation, Autologous Transplant, Melphalan
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Illinois at Chicago
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