Retrospective Study of Effect of Adjuvant Chemoradiation of Gastric Carcinoma on Local Control and Survival

Gastric Cancer Clinical Trial

Official title:

Retrospective Study of Effect of Adjuvant Chemoradiation of Gastric Carcinoma on Local Control and Survival

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05287672
• Other study ID #: 222
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: December 2023

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: Walaa Abdelshafy
• Phone: 01008313227
• Email: walaaabdelshafy45[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age between 18 to 70 years.

2. The World Health Organization Performance score 0-2.

3. Haemoglobin at least 10g/dl.

4. White blood cells at least 3000/mm3.

5. Platelets count at least 100000/mm3.

6. Bilirubin concentration no more than 25% higher than upper limit of normal .

7. Liver enzymes no greater than 2.5 times upper limit of normal.

8. Alkaline phosphatase no greater than 2 times upper limit of normal.

9. Creatinine concentration no more than 25% higher than the upper limit of normal .

Exclusion Criteria:

1. Second malignancy.

2. Prior abdominal irradiation.

3. Pregnant or nursing female.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain by BMI by kg/m2	Weight gain by BMI by kg/m2	2 years