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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01711242
Recruitment Status : Unknown
Verified April 2016 by xie congying, Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : October 22, 2012
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
xie congying, Wenzhou Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Capecitabine Drug: Oxaliplatin Radiation: Radiotherapy Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection
Study Start Date : January 2012
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: capecitabine/Oxaliplatin/radiotherapy

sequence chemoradiotherapy following radical resection

sequence chemoradiotherapy two cycles of XELOX + concurrent chemoradiotherapy + two cycles of XELOX.

Postoperative radiotherapy regimen: Radiotherapy consisted of 4500 centigray of radiation at 180 centigray per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.

Concurrent chemotherapy regimen: capecitabine 825 mg/m² twice daily Postoperative chemotherapy regimen: see arm 2

Drug: Capecitabine
Drug: Oxaliplatin
Radiation: Radiotherapy
Active Comparator: capecitabine/Oxaliplatin

chemotherapy alone following radical resection

Drug: chemotherapy alone following radical resection Postoperative chemotherapy regimen: The XELOX regimen was administrated: Oxaliplatin, 130mg/m2/day on day1, i.v. 2h; Capecitabine 1000mg/m²/day twice daily d1-14; every 21 days repeated, for 4 cycles.

Drug: Capecitabine
Drug: Oxaliplatin



Primary Outcome Measures :
  1. disease free survival [ Time Frame: 3-year ]

Secondary Outcome Measures :
  1. 5 year Overall Survival [ Time Frame: 5 years ]

Other Outcome Measures:
  1. Health-related quality of life [ Time Frame: five years after enrollment ]
    assessed by the Functional Assessment of Cancer Therapy-Esophageal (FACT-E)

  2. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: during treatment ]
    assessed by NCI Common Terminology Criteria v3.0



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven gastric cancer; ≥ D2 resection
  • Stage T3、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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711242


Locations
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China, Zhejiang
The First Affiliated Hospital of Wenzhou Medical College Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: congying xie, MD    86-0577-8806-9316    wzxiecongying@163.com   
Sponsors and Collaborators
xie congying
Investigators
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Principal Investigator: congying xie, MD First Affiliated Hospital of Wenzhou Medical University
Principal Investigator: xiaolei chen, MD First Affiliated Hospital of Wenzhou Medical University

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Responsible Party: xie congying, Director, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01711242    
Other Study ID Numbers: WZMC-12068
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016
Keywords provided by xie congying, Wenzhou Medical University:
gastric cancer
radiotherapy
postoperative therapy
chemotherapy
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents