NCT05287672

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

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

February 12, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

February 12, 2022

Last Update Submit

March 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight gain by BMI by kg/m2

    Weight gain by BMI by kg/m2

    2 years

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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 .
  • 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 .

You may not qualify if:

  • Second malignancy.
  • Prior abdominal irradiation.
  • Pregnant or nursing female.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecrurer

Study Record Dates

First Submitted

February 12, 2022

First Posted

March 18, 2022

Study Start

June 1, 2022

Primary Completion

July 1, 2023

Study Completion

December 1, 2023

Last Updated

March 18, 2022

Record last verified: 2022-03