Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma

Gastric Cancer Clinical Trial

Official title:

Phase II Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01711242
• Other study ID #: WZMC-12068
• Status: Completed
• Phase: Phase 2
• Start date: January 2012
• Est. completion date: January 2021

Study information

• Verified date: April 2022
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the trial is to compare disease-free survival between adjuvant XELOX alone vs XELOX with concurrent capecitabine and radiotherapy in curatively resected gastric cancer patients with D2 dissection.

Description:

Gastric cancer is one of the most common malignancies in China. Complete surgical resection is the only potentially curative therapy available to patients with gastric cancer. However, the overall survival results remain unsatisfactory. The main factor accounting for high mortality rate is the relapse after surgical resection. During the past few decades, the principle of combined modality treatment has been developed and applied in gastric cancer. Radiation therapy plus concurrent chemotherapy had demonstrated to be able to achieve a significant improvement in overall and disease-free survival according to Intergroup Trial 0116/Southwest Oncology Group 9008. Nevertheless, the result from Intergroup Trial 0116 study had been challenged by the fact that the surgical treatment applied in the trial was gastrectomy with limited lymph node dissection (D0 or D1) in 90% of cases. Therefore, it is debatable whether adjuvant chemoradiation therapy can confer survival benefit in patients with extensive lymph node dissection. In ARTIST study, the addition of concurrent capecitabine and radiotherapy to capecitabine and cisplatin chemotherapy did not significantly reduce recurrence after curative resection and D2 lymph node dissection in gastric cancer. In subgroup analysis of patients with positive pathologic lymphnodes, there was a statistically significant prolongation in disease-free survival in the concurrent treatment arm when compared with the chemotherapy alone arm. Furthermore, CLASSIC study showed that XELOX (oxaliplatin/capecitabine) combination given as adjuvant chemotherapy for stage II or III patients after D2 surgery could achieve a significant survival benefit. The standard treatment modality in gastric cancer after D2 dissection is still disputable. Thus, the assessment of the effect of adjuvant sequence chemoradiotherapy in D2 resected gastric cancer is essential.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: January 2021
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Histologically proven gastric cancer; = D2 resection

• Stage T1-4, N+

• 18 = age = 75

• Eastern Cooperative Oncology Group 0-2

• No distant metastasis

• Adequate bone marrow functions (absolute neutrophil count= 1,500/ul, blood platelet= 100,000/ul, haemoglobin= 10g/dl)

• Adequate renal functions(serum creatinine = 1.5mg/dl)

• Adequate liver functions (serum bilirubin = 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase = 3 times(normal value)

• Written informed consent

Exclusion Criteria:

• Previous history of immunotherapy, chemotherapy, radiotherapy for gastric cancer;

• Active infection requiring antibiotics;

• Pregnant, lactating women;

• Psychiatric illness, epileptic disorders;

• Concurrent systemic illness not appropriate for chemotherapy;

• Resection margin (+);

• History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma;

• D0, D1 resection;

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Capecitabine

• Oxaliplatin

Radiation:
• Radiotherapy

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
xie congying

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health-related quality of life	assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)	five years after enrollment
Other	Number of participants with adverse events as a measure of safety and tolerability	assessed by NCI Common Terminology Criteria v3.0	during treatment
Primary	disease free survival		3-year
Secondary	5 year Overall Survival		5 years