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Status unknownNCT04814784Updated Mar 24, 2021

Role of Neoadjuvent Radiotherapy in Locally Advanced Cancer Rectum

An observational study in Rectal Adenocarcinoma, sponsored by Amany sayed Abass. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by Amany sayed Abass · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
48
Ages
18 Years to 70 Years
Sex
All
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Study 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

Read the 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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Conditions studied

  • Rectal Adenocarcinoma

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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.

This study's planned enrollment of 48 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

This is the only study on the registry with Amany sayed Abass as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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

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
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
48 participants (estimated)
Patient registry
No

Interventions

  • RadiationNeoadjuvent 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

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What researchers measure

Primary outcomes

  1. Effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum

    Disease free survival.

    Time frame: 4 years

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Study locations

1 site
  • South Egypt cancer Institute
    Assiut, Egypt
    • Mostafa Elsayed Abd Elwanees, Professor · Contact · mostafawanis@yahoo.com · +201221133032
    • Hoda Hassan Eisa, Professor · Contact · hodahassanessa@yahoo.com · +201001732757
    • Mostafa Elsayed AbdElwanees, Professor · Principal investigator
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References and documents

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. Erratum In: CA Cancer J Clin. 2020 Jul;70(4):313. doi: 10.3322/caac.21609. PubMed 30207593 ↗
  • Song JH, Jeong JU, Lee JH, Kim SH, Cho HM, Um JW, Jang HS; Korean Clinical Practice Guideline for Colon and Rectal Cancer Committee. Preoperative chemoradiotherapy versus postoperative chemoradiotherapy for stage II-III resectable rectal cancer: a meta-analysis of randomized controlled trials. Radiat Oncol J. 2017 Sep;35(3):198-207. doi: 10.3857/roj.2017.00059. Epub 2017 Sep 15. PubMed 29037017 ↗
  • Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694. PubMed 15496622 ↗
  • Rodel C, Liersch T, Becker H, Fietkau R, Hohenberger W, Hothorn T, Graeven U, Arnold D, Lang-Welzenbach M, Raab HR, Sulberg H, Wittekind C, Potapov S, Staib L, Hess C, Weigang-Kohler K, Grabenbauer GG, Hoffmanns H, Lindemann F, Schlenska-Lange A, Folprecht G, Sauer R; German Rectal Cancer Study Group. Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial. Lancet Oncol. 2012 Jul;13(7):679-87. doi: 10.1016/S1470-2045(12)70187-0. Epub 2012 May 23. PubMed 22627104 ↗
  • Li Y, Wang J, Ma X, Tan L, Yan Y, Xue C, Hui B, Liu R, Ma H, Ren J. A Review of Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer. Int J Biol Sci. 2016 Jul 17;12(8):1022-31. doi: 10.7150/ijbs.15438. eCollection 2016. PubMed 27489505 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04814784
Lead sponsor
Amany sayed Abass
Responsible party
Amany sayed Abass (Physician Dr, Assiut University) — Sponsor-investigator
First posted
Mar 24, 2021
Start date
Mar 31, 2021 (estimated)
Primary completion
Oct 1, 2022 (estimated)
Completion
Oct 2022 (estimated)
Last update
Mar 24, 2021

Study contacts

Amany Sayed Abass
Contact
amanysayed385@gmail.com
+201066756847
Hanaa Sayed Abass
Contact
hanaasayed070@gmail.com
+201062149780

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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