Gastric CancerPhase 2NCT01711242
Trial of Adjuvant XELOX Chemotherapy and Concurrent Capecitabine and Radiotherapy for Resected Gastric Carcinoma
A Phase 2 study testing Capecitabine, Oxaliplatin and Radiotherapy in people with Gastric Cancer, run by xie congying at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Capecitabine, Oxaliplatin and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Jan 2021
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
About this study
Official title: Phase II Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Capecitabine, Oxaliplatin, Radiotherapy
- Keywords
- gastric cancer, radiotherapy, postoperative therapy, chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
OxaliplatinDrug
RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| capecitabine/Oxaliplatin/radiotherapy | Experimental | 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 Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy |
| capecitabine/Oxaliplatin | Active comparator | 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. Receives: Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 3-year
Secondary outcomes (1)
5 year Overall Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2020
- Study completionJan 2021
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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- xie congying
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xie congying, Wenzhou Medical University
- Investigators
- congying xie, MD, Principal investigator, First Affiliated Hospital of Wenzhou Medical Universityxiaolei chen, MD, Principal investigator, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711242
- Sponsor's protocol ID
- WZMC-12068
- Status last verified
- Apr 2022
- First submitted
- 14 Oct 2012
- Last updated
- 5 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Trial of Adjuvant XELOX Chemotherapy and XELOX With Concurrent Capecitabine and Radiotherapy for Gastric Adenocarcinoma With D2 Dissection
- ClinicalTrials.gov ID
- NCT01711242
- Acronym / sponsor ID
- WZMC-12068
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, radiotherapy, postoperative therapy, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- xie congyingUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 22 Oct 2012 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capecitabine/Oxaliplatin/radiotherapy | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Radiation: Radiotherapysequence 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 |
| capecitabine/Oxaliplatin | Active comparator | Drug: Capecitabine, Drug: Oxaliplatinchemotherapy 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically proven gastric cancer; ≥ D2 resection
- Stage T1-4, N+
- 18 ≤ age ≤ 75
- Eastern Cooperative Oncology Group 0-2
- No distant metastasis
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capecitabine | Drug | capecitabine/Oxaliplatin, capecitabine/Oxaliplatin/radiotherapy |
| Oxaliplatin | Drug | capecitabine/Oxaliplatin, capecitabine/Oxaliplatin/radiotherapy |
| Radiotherapy | Radiation | capecitabine/Oxaliplatin/radiotherapy |
Primary outcome
disease free survival
Time frame: 3-year
1 secondary outcome
5 year Overall Survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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.
congying xie, MD principal investigator
First Affiliated Hospital of Wenzhou Medical University
xiaolei chen, MD principal investigator
First Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine, Oxaliplatin and Radiotherapy in people with Gastric Cancer, run by xie congying at 1 site in China.
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 8 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: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: 3-year). 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 5 May 2022.