Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum
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|ClinicalTrials.gov Identifier: NCT04814784|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
|Condition or disease||Intervention/treatment|
|Rectal Adenocarcinoma||Radiation: Neoadjuvent radiotherapy either short or long course chemoradiation in treatment of locally advanced cancer rectum|
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 Type :||Observational|
|Estimated Enrollment :||48 participants|
|Official Title:||Retrospective Study Comparing Neoadjuvent Short Course of Radiotherapy to Conventional Chemoradiation in Cancer Rectum|
|Estimated Study Start Date :||March 31, 2021|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 2022|
- Radiation: Neoadjuvent radiotherapy either short or long course chemoradiation in treatment of locally advanced cancer rectum
Study the effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum e higher possiblity of preservation of anal sphincter and decreased rate of locoregional recurrence compared to surgery alone
- Effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum [ Time Frame: 4 years ]Disease free survival.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814784
|Contact: Amany Sayed Abassemail@example.com|
|Contact: Hanaa Sayed Abassfirstname.lastname@example.org|
|South Egypt cancer Institute|
|Contact: Mostafa Elsayed Abd Elwanees, Professor +201221133032 email@example.com|
|Contact: Hoda Hassan Eisa, Professor +201001732757 firstname.lastname@example.org|
|Principal Investigator: Mostafa Elsayed AbdElwanees, Professor|