Clinical Trials Logo

Clinical Trial Summary

This is a retrospective study comparing neoadjuvent short course radiotherapy to conventional chemoradiation in locally advanced cancer rectum and the effect of both regimens in overall survival and disease free survival


Clinical Trial Description

Colorectal cancer is the third most common cancer diagnosed in the western world. In 2019 there were approximately 44180 new cases of rectal cancer diagnosed in the United states. Due to the close proximity of the rectum to pelvic structures and organs, the absence of a serious membrane surrounding the rectum and the restriction of the surgical view and access by the pelvic cavity, the locoregional recurrence rate in rectal cancer is relatively high after surgery alone. Neoadjuvent therapy rather than surgery followed by adjuvent therap has been the preferred approach world wide in treatment of rectal cancer since the 2004 publication of the seminal German CAO/ARO/AIO-94 study ,which compared preoperative with postoperative chemoradiation in 823 patients The use of neoadjuvent therapy is recommended for all newly diagnosed rectal adenocarcinoma with a clinical stage T3 or T4 based on trans rectal endoscopic ultrasound or pelvic MRI .Neoadjuvent therapy may comprise of either radiotherapy alone or in combination with chemotherapy, commonly prescribed chemotherapy agents include 5-fluorouracil and Oxaloplatin. Both short course radiotherapy (25 Gy in 5 fractions) and long course radiotherapy (50.4Gy in 28 fractions, conventionally fractionated therapy)can be applied as neoadjuvent radiotherapy. Several phase lll RCTs,including three large well-designed international RCTs have reported that short course neoadjuvent radiation treatment improves local control compared with surgery alone in patients with respectable rectal cancer. Also ,neoadjuvent chemoradiation with long course radiotherapy can be recommended for most patients with stage ll- lll rectal cancer with the aim of reducing the risk of local recurrence, for reducing rates of perioperative and post operative complications and in an attempt to avoid radical surgery with permanent colostomy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04814784
Study type Observational
Source Assiut University
Contact Amany Sayed Abass
Phone +201066756847
Email amanysayed385@gmail.com
Status Not yet recruiting
Phase
Start date March 31, 2021
Completion date October 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05081024 - Establishing a ctDNA Biomarker to Improve Organ Preserving Strategies in Patients With Rectal Cancer
Not yet recruiting NCT04090450 - Optimisation of Radiotherapy in Rectal Cancer (ORREC)
Recruiting NCT06050447 - Factors Affecting the Results of Treatment of Patients With Colorectal Cancer
Terminated NCT02233595 - Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Completed NCT02935309 - Capecitabine and Lenvatinib With External Radiation in Rectal Adenocarcinoma Phase 1
Terminated NCT01887509 - Evaluation of Rectal Tumor Margin Using Confocal Endomicroscopy and Comparison to Histopathology N/A
Recruiting NCT05746195 - Optimization of Adaptive Text Messages for Cancer Survivors (OATS II) N/A
Active, not recruiting NCT03365882 - S1613, Trastuzumab and Pertuzumab or Cetuximab and Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic HER2/Neu Amplified Colorectal Cancer That Cannot Be Removed by Surgery Phase 2
Completed NCT02314182 - GRECCAR 8: Primary Tumor Resection in Rectal Cancer With Unresectable Metastasis Phase 3
Completed NCT02393755 - Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT04441580 - Assessing the Additional Neoplasia Yield of Computer-aided Colonoscopy in a Screening Setting N/A
Terminated NCT03527784 - Prestoma-Trial for Parastomal Hernia Prevention N/A
Completed NCT00855946 - Proteomic Approach Using Matrix-assisted Laser Desorption/Ionization Tandem Time-of-flight (MALDI-TOF/TOF) of Tumor Response in Rectal Carcinoma After Radiochemotherapy N/A
Recruiting NCT06328361 - Nordic ORgan Preservation Pilot Approach Nonrandomised Single-Arm Trial for Non-Operative Management of Rectal Cancer N/A
Recruiting NCT02107105 - Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
Terminated NCT03300544 - Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer Phase 1
Active, not recruiting NCT03436563 - M7824 in Patients With Metastatic Colorectal Cancer or With Advanced Solid Tumors With Microsatellite Instability Phase 1/Phase 2
Recruiting NCT05482516 - Evaluating Novel Therapies in ctDNA Positive GI Cancers Phase 3
Completed NCT02368886 - Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer Phase 2
Active, not recruiting NCT02688712 - ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer Phase 2