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Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04814784
Recruitment Status : Not yet recruiting
First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Information provided by (Responsible Party):
Amany sayed Abass, Assiut University

Brief 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

Condition or disease Intervention/treatment
Rectal Adenocarcinoma Radiation: Neoadjuvent radiotherapy either short or long course chemoradiation in treatment of locally advanced cancer rectum

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum [ Time Frame: 4 years ]
    Disease free survival.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Locally advanced cancer rectum patients stage ll ,lll who received neoadjuvent radiotherapy either short or long course chemoradiation before surgery

Inclusion Criteria:

  • histologically proved adenocarcinoma of the rectum
  • Age between 18 and 70 yrs
  • T3 and T4 N1,N2 respectable tumor
  • The WHO performance score 0-2
  • have a free metastatic work up excluded by chest x-ray , abdominal ultrasonography or CT pelviabdomen

Exclusion Criteria:

  • patients with locally advanced inoperable disease locally recurrent rectal cancer
  • had a history of malignant tumor within 5 years except the skin cancer
  • pregnant or lactating women
  • previous irradiation in pelvis
  • there was contraindication for neoadjuvent radiotherapy or surgery
  • known metastatic disease
  • mental disorder

Information from the National Library of Medicine

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 identifier (NCT number): NCT04814784

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Contact: Amany Sayed Abass +201066756847
Contact: Hanaa Sayed Abass +201062149780

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South Egypt cancer Institute
Assiut, Egypt
Contact: Mostafa Elsayed Abd Elwanees, Professor    +201221133032   
Contact: Hoda Hassan Eisa, Professor    +201001732757   
Principal Investigator: Mostafa Elsayed AbdElwanees, Professor         
Sponsors and Collaborators
Amany sayed Abass

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Responsible Party: Amany sayed Abass, Physician Dr, Assiut University Identifier: NCT04814784    
Other Study ID Numbers: Radiotherapy in rectal cancer
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 24, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type