Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients

May 27, 2015 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.

The aim of this study is to evaluate the efficacy of a neoadjuvant approach in patients with locally advanced gastric cancer and the identification of prognostic factors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with locally advanced gastric cancer (T3-4 and/or N+) are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound.

The neoadjuvant strategy consists of 3-4 cycles of induction chemotherapy followed by concurrent chemoradiotherapy. Chemoradiotherapy comprises weekly chemotherapy concurrently with daily external beam radiotherapy up to 45 Gy). Surgery is scheduled 4 to 6 weeks after the end of CRT. Pathological response is graded according to the Becker criteria. Statistical analysis is performed IBM SPSS v20.

Estimate whether R0 resection rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted by dynamic prognostic factors as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)

Study Type

Observational

Enrollment (Actual)

46

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

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with locally advanced adenocarcinoma of the stomach treated with a neoadjuvant protocol consisting of induction chemotherapy (ICT), chemoradiotherapy (CRT)and salvage surgery. Patients must have a medically fit condition to complete the protocol.

Initial staging comprises a thoracic and abdominal computerised tomography scan, endoscopic ultrasound endoscopy (EUS), biopsy and blood test including blood cell count, hepatic and renal function.

Radiological and endoscopic evaluations are performed at baseline and at the completion of ICT and CRT.

Blood tests are acquired at baseline, before each chemotherapy course and concurrently with evaluations. Blood tests are also obtained during follow-up and at the time progression.

Description

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the stomach
  • 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
  • Tumors involving the esophageal junction, comprising siewert I to III

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of treatment until death, assessed up to 10 years
Overall was defined as the period from diagnosis until death (from any cause).
From date of treatment until death, assessed up to 10 years
Identification of prognostic factors for overall survival
Time Frame: From date of treatment until death, assessed up to 10 years
Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients
From date of treatment until death, assessed up to 10 years
Disease-free survival
Time Frame: From date of diagnosis until progression or death, assessed up to 10 years
Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer.
From date of diagnosis until progression or death, assessed up to 10 years
R0 resection rate
Time Frame: Week 24 to 28
The R0 resection rate in the patients treated with the neoadjuvant protocol. R0 is defined as a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.
Week 24 to 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological response
Time Frame: Week 24 to 28
Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
Week 24 to 28
Patterns of treatment failure
Time Frame: From date of diagnosis until treatment failure, assessed up to 10 years
Type of recurrence: local, regional and/or distant.
From date of diagnosis until treatment failure, assessed up to 10 years
Adverse events are assessed according to CTC criteria v 4.0
Time Frame: Week 1 to 20
Safety and tolerability during the neoadjuvant protocol.
Week 1 to 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Investigators

  • Principal Investigator: javier Rodriguez Rodriguez, MD, PhD, CUN

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

September 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

May 22, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC-PKPDGN

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.

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