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AzTrials

Gastric AdenocarcinomaNCT04810663

Outcome of Radiation Therapy in Operated Gastric Cancer

An observational study of Gastric Adenocarcinoma, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Study tolerability and toxicity of radiotherapy with or without chemotherapy for operated gastric cancer. Evaluate the efficacy of adjuvant radiotherapy with or without chemotherapy as regarding local control and overall survival. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
Radiotherapy
Type of treatment
Surgery or procedure
How many people
40 participants
Where
No sites listed yet
Study dates
1 Apr 2021to 1 Apr 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Age of the patient; ≥18 and ≤75 years. Histologically proven gastric or gastroesophageal adenocarcinoma. Pt received adjuvant Radiotherapy with or without chemotherapy with any protocol.

Who may be able to join

  • Age of the patient; ≥18 and ≤75 years.
  • Histologically proven gastric or gastroesophageal adenocarcinoma.
  • Pt received adjuvant Radiotherapy with or without chemotherapy with any protocol.

Who cannot join

  • Patient >75 years\&<18 years.
  • Histologically types other than adenocarcinoma .
  • Metastatic patients (M1).
  • Pt didn't recive radiotherapy.

Trial locations and contacts

No sites are listed yet.

Mohamed Ahmed Ezzat, Master degree contact

+201068490648

maezzatma9@gmail.com

About this study

Official title: Outcome of Radiation Therapy In Operated Gastric Cancer

  • Study tolerability and toxicity of radiotherapy with or without chemotherapy for operated gastric cancer.
  • Evaluate the efficacy of adjuvant radiotherapy with or without chemotherapy as regarding local control and overall survival.
Being tested
Radiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    Adjuvant Radiotherapy in operated gastric cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of Radiotherapy in operated gastric cancer

    Disease Free Survival

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start1 Apr 2021 (estimated)
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Apr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04810663
Sponsor's protocol ID
Radiotherapy in gastric cancer
Status last verified
Mar 2021
First submitted
8 Mar 2021
Last updated
23 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 1- A. Schernberg,a E. Rivin del Campo,a B. Rousseau,b O. Matzinger,c M. Loi,d P. Maingon,e,f and F. Hugue. Adjuvant chemoradiation for gastric carcinoma: State of the art and perspectives. ClinTranslRadiatOncol. 2018 Mar 13: 13-22. 2- Karimi P., Islami F., Anandasabapathy S., Freedman N.D., Kamangar F. Gastric cancer: descriptive epidemiology, risk factors, screening, and prevention. Cancer Epidemiol Biomarkers Prev. 2014;23(5):700-713. 3- Forman D., Burley V.J. Gastric cancer: global pattern of the disease and an overview of environmental risk factors. Best Pract Res ClinGastroenterol. 2006;20(4):633-649. 4- Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. Lyon, France: International Agency for Research on Cancer; 2013. [Internet]. [cited 2014 Feb 22]. Available from: <http://globocan.iarc.fr/Pages/references.aspx>. 5- Ministry of Health and Population. Gharbiah Population Based Cancer Registry, Egypt. .Cancer in Egypt, triennial report of 2000-2002. 2007. MOH: Tanta, Egypt. 6-Alieldin N. NCI hospital-based registry 2002-2010 [Internet]. [cited 2014 Feb23].Availablefrom:<http://nci.cu.edu.eg/App_Files/registry/NCI_registry%202002-2010.pdf>. 7-Freedman L, Edwards B, Ries L, Young J, editors. Cancer incidence in four member countries (Cyprus, Egypt, Israel, and Jordan) of the Middle East Cancer Consortium (MECC) Compared with US SEER. National Cancer Institute, 2006. NIH Pub. No. 06-5873. Bethesda, MD [Internet]. [cited 2014 Feb 22]. 8- Zhou XM, Wong BC, Fan XM, Zhang HB, Lin MC, Kung HF, et al. Non-steroidal anti-inflammatory drugs induce apoptosis in gastric cancer cells through upregulation of bax and bak. Carcinogenesis. 2001;22:1393-97 9-Sasazuki S, Inoue M, Iwasaki M, Otani T, Yamamoto S, Ikeda S, et al. Effect of helicobacter pylori infection combined with cagA and pepsinogen status on gastric cancer development among Japanese men and women: A nested case-control study. Cancer Epidemiol. Biomarkers Prev. 2006;15:1341-47. 10- Tomonaga M, Oka M, Narasaki F, Fukuda M, Nakano R, Takatani H, et al. The multidrug resistance-associated protein gene confers drug resistance in human gastric and colon cancers. Jpn J Cancer Res. 1996;87:1263-70. 11-Buckland G, Travier N, Huerta JM, et al. Healthy lifestyle index and risk of gastric adenocarcinomaintheEPIC cohort study.IntJ Cancer. 2015;137(3):598-606. 12-Massarrat S, Stolte M. Development of gastric cancer and its prevention. Arch Iran Med. 2014;17(7):514-520. 13-Zhang ZX, ,Gu XZ, , Yin WB, , Huang GJ, , Zhang DW, , Zhang RG. Randomized clinical trial on the combination of preoperative irradiation and surgery in the treatment of adenocarcinoma of gastric cardia (AGC)-report on 370 patients. Int J RadiatOncolBiolPhys 1998; 42: 929-34. 14- Macdonald JS, , Smalley SR, , Benedetti J, , Hundahl SA, , Estes NC, , Stemmermann GN, et al. . Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med 2001; 345: 725-30. 15- M Fan W Hu Z Zhang. Chemoradiation for gastric cancer: controversies, updates and novel techniques. Br J Radiol July 2015; ( 88(1051).

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Adenocarcinoma, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Ahmed Ezzat, Master degree (+201068490648, maezzatma9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Radiotherapy in operated gastric cancer (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04810663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.

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