Clinical trial NCT01130337: A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Disease-free Survival (DFS) at Month 18
timeFrame: Month 18
Secondary outcomes:
measure: Percentage of Participants With Pathological Complete Response (pCR)
timeFrame: 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
measure: Percentage of Participants With Complete Tumor Resection (R0)
timeFrame: 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
measure: Percentage of Participants With Objective Response
timeFrame: 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
Other outcomes:
Locations:
city: Elche
country: Spain
state: Alicante
city: Oviedo
country: Spain
state: Asturias
city: Santander
country: Spain
state: Cantabria
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Vigo
country: Spain
state: Pontevedra
city: La Laguna
country: Spain
state: Tenerife
city: Barakaldo
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Cordoba
country: Spain
city: Granada
country: Spain
city: La Coruña
country: Spain
city: Leon
country: Spain
city: Lerida
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Orense
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.