- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01130337
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
September 1, 2015 updated by: Hoffmann-La Roche
An Open-label, Multi-center Study to Evaluate the Disease Free Survival Rate of a Perioperative Combination of Capecitabine (Xeloda), Trastuzumab (Herceptin) and Oxaliplatin (XELOX- Trastuzumab) in Patients With Resectable Gastric or Gastro-esophageal Junction Adenocarcinoma
This study will evaluate the disease free survival rate of a combination of capecitabine [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients with resectable gastric cancer.
The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor.
If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone.
Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle.
The anticipated time on study drug will be 12 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08036
-
Barcelona, Spain, 08003
-
Barcelona, Spain, 08035
-
Barcelona, Spain, 08907
-
Barcelona, Spain, 08916
-
Burgos, Spain, 09006
-
Cordoba, Spain, 14004
-
Granada, Spain, 18014
-
La Coruña, Spain, 15006
-
Leon, Spain, 24071
-
Lerida, Spain, 25198
-
Lugo, Spain, 27003
-
Madrid, Spain, 28040
-
Madrid, Spain, 28041
-
Madrid, Spain, 28007
-
Orense, Spain, 32005
-
Sevilla, Spain, 41014
-
Sevilla, Spain, 41013
-
Toledo, Spain, 45004
-
Valencia, Spain, 46014
-
Valencia, Spain, 46009
-
Zaragoza, Spain, 50009
-
-
Alicante
-
Elche, Alicante, Spain, 03203
-
-
Asturias
-
Oviedo, Asturias, Spain, 33006
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
-
-
Guipuzcoa
-
San Sebastian, Guipuzcoa, Spain, 20014
-
-
Islas Baleares
-
Palma de Mallorca, Islas Baleares, Spain, 07198
-
-
Pontevedra
-
Vigo, Pontevedra, Spain, 36204
-
-
Tenerife
-
La Laguna, Tenerife, Spain, 38320
-
-
Vizcaya
-
Barakaldo, Vizcaya, Spain, 48903
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients over 18 years of age
- Locally advanced resectable HER2-positive gastric or esophagogastric junction adenocarcinoma (Sievert types I, II, III)
- Measurable (RECIST criteria) or assessable disease
- ECOG performance 0-2
- Life expectancy of 12 weeks or more
Exclusion Criteria:
- Immeasurable lesion as the only evidence of disease
- Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous surgical resection of the tumor (except diagnostic laparoscopy)
- Concomitant heart disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
130 mg/m2 intravenous infusion day 1 of every cycle
First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Disease-free Survival (DFS) at Month 18
Time Frame: Month 18
|
DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first).
Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir.
When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase.
Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).
|
Month 18
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Pathological Complete Response (pCR)
Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
|
pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.
|
Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
|
Percentage of Participants With Complete Tumor Resection (R0)
Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
|
R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.
|
Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
|
Percentage of Participants With Objective Response
Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
|
An objective response was defined as either a complete response (CR) or a partial response (PR).
Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions.
PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.
|
Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
May 25, 2010
First Submitted That Met QC Criteria
May 25, 2010
First Posted (Estimate)
May 26, 2010
Study Record Updates
Last Update Posted (Estimate)
October 1, 2015
Last Update Submitted That Met QC Criteria
September 1, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Trastuzumab
- Capecitabine
- Oxaliplatin
Other Study ID Numbers
- ML25189
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastric Cancer
-
City of Hope Medical CenterRecruitingGastric Cancer | Gastric Adenocarcinoma | Gastric Cancer Stage IV | Gastric Neoplasm | Gastric Cancer Metastatic to Lung | Gastric Cancer Stage | Gastric Cancer Metastatic to Liver | Gastric Cancer Stage III | Gastric Cancer Stage II | Gastric Lesion | Gastric Cancer in Situ | Gastric Cancer Stage IIIB | Gastric... and other conditionsUnited States, Japan
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage 0 Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage II Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IIB Gastric Cancer AJCC v8 | Pathologic Stage... and other conditionsUnited States
-
City of Hope Medical CenterActive, not recruitingAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Diffuse Adenocarcinoma of the Stomach | Intestinal Adenocarcinoma of the Stomach | Mixed Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric Cancer and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingGastric Adenocarcinoma | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage I Gastric Cancer AJCC v8 | Clinical Stage IIA Gastric Cancer AJCC v8 | Clinical Stage IVA Gastric Cancer AJCC v8 | Pathologic Stage IB Gastric Cancer AJCC v8 | Pathologic Stage II Gastric Cancer AJCC v8 | Pathologic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedGastric Adenocarcinoma | Stage IV Gastric Cancer | Stage II Gastric Cancer | Stage III Gastric CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedGastroesophageal Junction Adenocarcinoma | Gastric Cardia Adenocarcinoma | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage IIIB Gastric Cancer AJCC v7United States
-
National Cancer Institute (NCI)CompletedAdenocarcinoma of the Gastroesophageal Junction | Stage IV Gastric Cancer | Recurrent Gastric Cancer | Adenocarcinoma of the Stomach | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric CancerUnited States
-
National Cancer Institute (NCI)CompletedGastric Cancer | Gastric NeoplasmsUnited States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedGastric Cancer | Esophageal Cancer | Adenocarcinoma Gastric | Metastatic Gastric Cancer | GastroEsophageal Cancer | HER2 Positive Gastric CancerGermany
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)RecruitingGastric Adenocarcinoma | Epstein-Barr Virus Positive | Mismatch Repair Protein Deficiency | Stage IB Gastric Cancer AJCC v7 | Stage II Gastric Cancer AJCC v7 | Stage IIA Gastric Cancer AJCC v7 | Stage IIB Gastric Cancer AJCC v7 | Stage III Gastric Cancer AJCC v7 | Stage IIIA Gastric Cancer AJCC v7 | Stage... and other conditionsUnited States
Clinical Trials on Capecitabine [Xeloda]
-
Hoffmann-La RocheCompletedColorectal CancerSlovakia
-
University of AarhusPierre Fabre LaboratoriesCompleted
-
Hoffmann-La RocheCompletedBreast Cancer, Colorectal CancerNew Zealand, Australia, United Kingdom
-
Asan Medical CenterUlsan University Hospital; Seoul National University Bundang Hospital; Gachon... and other collaboratorsRecruitingGastric CancerKorea, Republic of
-
Hoffmann-La RocheTerminated
-
Hoffmann-La RocheCompleted
-
Cambridge University Hospitals NHS Foundation TrustCompletedPancreatic AdenocarcinomaUnited Kingdom
-
Hoffmann-La RocheCompleted
-
Sun Yat-sen UniversityRecruiting
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI)Completed