Rectal Neoplasms Clinical Trial
Official title:
Phase III Study of Neoadjuvant Chemotherapy With Capecitabine and Oxaliplatin Versus Chemoradiation for Locally Advanced Rectal Cancer Patients
Although neoadjuvant radiotherapy greatly decreases local recurrence in locally advanced rectal cancer patients undergoing surgery, it inevitably results in short-term and long-term toxicities. More importantly, it has not been confirmed that neoadjuvant radiotherapy could improve overall survival. The purpose of this study is to compare the effects of chemotherapy alone using a combination regimen known as XELOX (capecitabine and oxaliplatin ) and selective use of the standard treatment to the standard treatment of chemotherapy and radiation.
This randomised, open-label, multicentre,phase 3 trial began in August, 2014, as an adjuvant trial comparing capecitabine-based neoadjuvant chemoradiotherapy with chemotherapy alone,in patients aged 18 years to 75 with clinical stage II-III locally advanced rectal cancer from six Chinese institutions. Patients with local advanced rectal cancer (T2N+ or T3-4aNany,M0, CRM≥2mm, 12cm from the anus verge) were scheduled to Group A: receive neoadjuvant chemotherapy alone (4 cycles of XELOX: oxaliplatin 130mg/m2 day 1，capecitabine 2000mg/m2 days 1-14, repeated every 21 days) followed by radical surgery and 4 cycles of XELOX ( oxaliplatin 130mg/m2 day 1，capecitabine 2000mg/m2 days 1-14, repeated every 21 days) and Group B :chemoradiotherapy (50.4 Gy plus capecitabine 1650 mg/m² administered orally and concurrently with radiation therapy for 5 days per week.) followed by radical surgery and 6 cycles of XELOX ( oxaliplatin 130mg/m2 day 1，capecitabine 2000mg/m2 days 1-14, repeated every 21 days) The primary endpoint was 3-year local recurrence free survival; analyses were done based on all patients with post-randomization data. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02537340 -
PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
|
||
| Recruiting |
NCT02565667 -
A Prospective Clinical Study for Transanal Double Purse-string Rectal Anastomosis Preformed With KOL Stapler
|
N/A | |
| Not yet recruiting |
NCT02439086 -
Prediction of Response to Neoadjuvant Therapy in Rectal Cancer
|
N/A | |
| Terminated |
NCT02538913 -
Exercise Training for Rectal Cancer Patients
|
N/A | |
| Completed |
NCT02233374 -
Predicting RadIotherapy ReSponse of Rectal Cancer With MRI and PET
|
N/A | |
| Completed |
NCT00535652 -
Concentration of Ertapenem in Colorectal Tissue
|
Phase 4 | |
| Completed |
NCT00535041 -
Pilot Trial of Pre-operative Chemo/RT Using Xeloda and External Beam RT Followed by Definite Surgery in Patients With Localized Rectal CA
|
N/A | |
| Recruiting |
NCT04949646 -
Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision
|
N/A | |
| Recruiting |
NCT04095468 -
Organ-preserving Management in Patients With Complete or Near-complete Tumour Response After Preoperative Radio(Chemo)Therapy for Rectal Cancer
|
||
| Recruiting |
NCT06017583 -
Neoadjuvant Chemotherapy With PD-1 Inhibitors Combined With SIB-IMRT in the Treatment of Locally Advanced Rectal Cancer
|
Phase 3 | |
| Recruiting |
NCT05689775 -
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
|
||
| Recruiting |
NCT04006951 -
Development of a Clinical and Biological Database in Rectum Cancer
|
N/A | |
| Recruiting |
NCT05068180 -
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
|
Phase 4 | |
| Recruiting |
NCT03714490 -
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer
|
Phase 2 | |
| Recruiting |
NCT03325361 -
The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
|
N/A | |
| Completed |
NCT02252250 -
Transanal Total Mesorectal Excision Versus Laparoscopic TME for Rectal Cancer
|
N/A | |
| Completed |
NCT01816607 -
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness
|
||
| Completed |
NCT04455737 -
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
|
||
| Completed |
NCT01721785 -
Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer
|
N/A | |
| Active, not recruiting |
NCT01171300 -
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
|
N/A |