A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
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
1 other identifier
interventional
36
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 gastric-cancer
Started Jul 2010
Typical duration for phase_2 gastric-cancer
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
October 1, 2015
CompletedOctober 1, 2015
September 1, 2015
3.9 years
May 25, 2010
September 1, 2015
September 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Disease-free Survival (DFS) at 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 Outcomes (3)
Percentage of Participants With Pathological Complete Response (pCR)
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)
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
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
Study Arms (1)
1
EXPERIMENTALInterventions
1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Elche, Alicante, 03203, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Barcelona, Barcelona, 08003, Spain
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Barcelona, Barcelona, 08036, Spain
Unknown Facility
Barcelona, Barcelona, 08907, Spain
Unknown Facility
Barcelona, Barcelona, 08916, Spain
Unknown Facility
Burgos, Burgos, 09006, Spain
Unknown Facility
Santander, Cantabria, 39008, Spain
Unknown Facility
Córdoba, Cordoba, 14004, Spain
Unknown Facility
Granada, Granada, 18014, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Unknown Facility
A Coruña, La Coruña, 15006, Spain
Unknown Facility
León, Leon, 24071, Spain
Unknown Facility
Lleida, Lerida, 25198, Spain
Unknown Facility
Lugo, Lugo, 27003, Spain
Unknown Facility
Madrid, Madrid, 28007, Spain
Unknown Facility
Madrid, Madrid, 28040, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Ourense, Orense, 32005, Spain
Unknown Facility
Vigo, Pontevedra, 36204, Spain
Unknown Facility
Oviedo, Principality of Asturias, 33006, Spain
Unknown Facility
Seville, Sevilla, 41013, Spain
Unknown Facility
Seville, Sevilla, 41014, Spain
Unknown Facility
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Unknown Facility
Toledo, Toledo, 45004, Spain
Unknown Facility
Valencia, Valencia, 46009, Spain
Unknown Facility
Valencia, Valencia, 46014, Spain
Unknown Facility
Barakaldo, Vizcaya, 48903, Spain
Unknown Facility
Zaragoza, Zaragoza, 50009, Spain
Related Publications (1)
Rivera F, Izquierdo-Manuel M, Garcia-Alfonso P, Martinez de Castro E, Gallego J, Limon ML, Alsina M, Lopez L, Galan M, Falco E, Manzano JL, Gonzalez E, Munoz-Unceta N, Lopez C, Aranda E, Fernandez E, Jorge M, Jimenez-Fonseca P. Perioperative trastuzumab, capecitabine and oxaliplatin in patients with HER2-positive resectable gastric or gastro-oesophageal junction adenocarcinoma: NEOHX phase II trial. Eur J Cancer. 2021 Mar;145:158-167. doi: 10.1016/j.ejca.2020.12.005. Epub 2021 Jan 20.
PMID: 33485079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 26, 2010
Study Start
July 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
October 1, 2015
Results First Posted
October 1, 2015
Record last verified: 2015-09