NCT04814784

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

March 19, 2021

Last Update Submit

March 23, 2021

Conditions

Rectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum

    Disease free survival.

    4 years

Interventions

Neoadjuvent radiotherapy either short or long course chemoradiation in treatment of locally advanced cancer rectumRADIATION

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Locally advanced cancer rectum patients stage ll ,lll who received neoadjuvent radiotherapy either short or long course chemoradiation before surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt cancer Institute

Asyut, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 30207593BACKGROUND

  • 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.

    PMID: 29037017BACKGROUND

  • 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.

    PMID: 15496622BACKGROUND

  • 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.

    PMID: 22627104BACKGROUND

  • 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.

    PMID: 27489505BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Amany Sayed Abass

CONTACT

+201066756847amanysayed385@gmail.com

Hanaa Sayed Abass

CONTACT

+201062149780hanaasayed070@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physician Dr

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 24, 2021

Study Start

March 31, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations

EG(1)