Gastric CancerNCT05287672
Retrospective Study of Effect of Adjuvant Chemoradiation of Gastric Carcinoma on Local Control and Survival
An observational study of Gastric Cancer, run by Assiut University.
Trial summary
Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world. The American Cancer Society estimates that about 26,560 cases of stomach cancer (16,160 in men and 10,400 in women) will be diagnosed in 2021. Median age at diagnosis is 68 years. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 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 70 years
- All sexes
- Adult, Older adult
Study population: Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world. Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries. Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease. Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.
Who may be able to join
- Age between 18 to 70 years.
- The World Health Organization Performance score 0-2.
- Haemoglobin at least 10g/dl.
- White blood cells at least 3000/mm3.
- Platelets count at least 100000/mm3.
- Bilirubin concentration no more than 25% higher than upper limit of normal .
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- Liver enzymes no greater than 2.5 times upper limit of normal.
- Alkaline phosphatase no greater than 2 times upper limit of normal.
- Creatinine concentration no more than 25% higher than the upper limit of normal .
Who cannot join
- Second malignancy.
- Prior abdominal irradiation.
- Pregnant or nursing female.
Trial locations and contacts
No sites are listed yet.
About this study
Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world.
The American Cancer Society estimates that about 26,560 cases of stomach cancer (16,160 in men and 10,400 in women) will be diagnosed in 2021. Median age at diagnosis is 68 years.
Read more
Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries.
Surgical resection is the principal therapy for gastric cancer, as it offers the only potential for cure.
Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease.
Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.
Read the detailed description
Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world.
The American Cancer Society estimates that about 26,560 cases of stomach cancer (16,160 in men and 10,400 in women) will be diagnosed in 2021. Median age at diagnosis is 68 years.
Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries.
Surgical resection is the principal therapy for gastric cancer, as it offers the only potential for cure.
Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease.
Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.
- Conditions
- Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain by BMI by kg/m2
Weight gain by BMI by kg/m2
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study startJun 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Abdelshafy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287672
- Sponsor's protocol ID
- 222
- Status last verified
- Mar 2022
- First submitted
- 12 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Effect of Adjuvant Chemoradiation of Gastric Carcinoma on Local Control and Survival
- ClinicalTrials.gov ID
- NCT05287672
- Acronym / sponsor ID
- 222
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world.
The American Cancer Society estimates that about 26,560 cases of stomach cancer (16,160 in men and 10,400 in women) will be diagnosed in 2021. Median age at diagnosis is 68 years.
Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries.
Surgical resection is the principal therapy for gastric cancer, as it offers the only potential for cure.
Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease.
Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.
Detailed description
Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world.
The American Cancer Society estimates that about 26,560 cases of stomach cancer (16,160 in men and 10,400 in women) will be diagnosed in 2021. Median age at diagnosis is 68 years.
Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries.
Surgical resection is the principal therapy for gastric cancer, as it offers the only potential for cure.
Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease.
Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer is the sixth most common cancer and the third most common cause of cancer-related death in the world. Decreases in gastric cancer have been attributed in part to widespread use of refrigeration. Other factors likely contributing to the decline in stomach cancer rates include lower rates of chronic Helicobacter pylori infection, thanks to improved sanitation and use of antibiotics, and increased screening in some countries. Neoadjuvant chemotherapy has an established role in the management of gastric cancer. Perioperative chemotherapy, or postoperative chemotherapy plus chemoradiation, are preferred for localized gastric cancer. Because of lower toxicity, two-drug cytotoxic regimens are preferred for patients with advanced disease. Adjuvant radiotherapy is associated with improvements in both overall and relapse-free survival and reductions in locoregional failure.
Key inclusion criteria (9 listed)
- Age between 18 to 70 years.
- The World Health Organization Performance score 0-2.
- Haemoglobin at least 10g/dl.
- White blood cells at least 3000/mm3.
- Platelets count at least 100000/mm3.
Key exclusion criteria (3 listed)
- Second malignancy.
- Prior abdominal irradiation.
- Pregnant or nursing female.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Weight gain by BMI by kg/m2
Time frame: 2 years
Weight gain by BMI by kg/m2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, 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 9 inclusion and 3 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 18 Mar 2022. 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 Walaa Abdelshafy (01008313227, walaaabdelshafy45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight gain by BMI by kg/m2 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2022.