Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer

Plain-language summary

This is an observational study investigating individualized treatment in patients with locally advanced gastric and gastroesophageal cancer. It included histologically confirmed patients aged 18 and over who had not previously received chemotherapy. It was conducted as a non-phase observational study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Start date

9/1/2013

Estimated completion

3/1/2015

Countries

Spain

Related genes

Locations

• Pamplona, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the stomach or gastroesophageal cancer
* Age ≥18 years old
* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
* Body mass index ≥ 18
* No prior chemotherapy or chemoradiotherapy
* TNM stage of T3-T4 and/or positive regional lymph nodes (N+) by endoscopic ultrasound or computed tomography (CT)
* No evidence of metastasis (M0)
* Adequate hematological, liver and renal functions (ALT and AST≤2.5 UNL, total bilirubin ≤1.5 UNL, and serum creatinine ≤1.5 UNL)

Exclusion Criteria:

* Patients with previous (less than 10 years) or current history of malignant neoplasms, except for curatively treated
* Patients with evidence of severe or uncontrolled systemic disease
* Medically unfit for chemotherapy