The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

Neoadjuvant Chemotherapy Versus Surgery Alone in Locally Advanced Gastric Cancer: A Randomized Controlled Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01444755

Enrollment

Registered

2011-10-03

Start date

2009-01-31

Completion date

2012-04-30

Last updated

2011-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Locally advanced gastric cancer, neoadjuvant chemotherapy

Brief summary

The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen in patient with resectable locally advanced gastric cancer in comparison with surgery alone.

Detailed description

Adenocarcinoma of the stomach ranks as the fourth most commonly diagnosed cancer and as the second leading cause of cancer-related death in the world. Radical resection with free-margin gastrectomy and extended lymphadenectomy is the preferred surgical strategy in Japan and Asian centers. Unfortunately, only one-half of surgically treated patients with gastric cancer will achieve a complete resection without residual disease (R0) resection. Moreover, due to, the absence of routine screening programs for gastric cancer, the majority of the patients will be symptomatic at the time of diagnosis in our country. Additionally, recent treatment strategies were focused for downsizing or decreasing to loco-regional recurrence. In this reason, we hypothesize that preoperative chemotherapy may improve the R0 resection rate or disease free and/or overall survival rate.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Histologically proven adenocarcinoma of stomach * T3 or T4 * N1 or N2 * M0 * No evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal dissemination or Krukenberg tumor. * No involvement of the esophagus with \> 2cm * An age of 18-90 years * A Karnofsky Performance status with 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status (0-2) * No previous chemotherapy, radiotherapy for any malignancy. * No previous surgery for gastric cancer * No evidence obstructive or bleeding symptoms. * Adequate renal and hepatic function * Written informed consent

Exclusion criteria

* Synchronous or metachronous malignancy diagnosing within 5 year * Pregnancy or lactation in female patients * Any immunosuppressive condition (acquired or iatrogenic) * Any infectious toxic or mental condition preventing neoadjuvant therapy

Design outcomes

Primary

Measure	Time frame
Survival	After 2 years from therapy

Countries

Turkey (Türkiye)

Outcome results