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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02454647
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary:
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.

Condition or disease Intervention/treatment
Gastric Cancer Adenocarcinoma Effects of Chemotherapy Surgery Gastrointestinal Neoplasms Drug: Induction chemotherapy Radiation: Radiotherapy with concurrent chemotherapy Procedure: Salvage surgery

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
Actual Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.
Study Start Date : September 2013
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Adverse events are assessed according to CTC criteria v 4.0 [ Time Frame: Week 1 to 20 ]
    Safety and tolerability during the neoadjuvant protocol.

Biospecimen Retention:   Samples With DNA
Surgical specimen with potential for extraction of DNA.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02454647

Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Principal Investigator: javier Rodriguez Rodriguez, MD, PhD CUN

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra Identifier: NCT02454647     History of Changes
Other Study ID Numbers: GC-PKPDGN
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Neoadjuvant therapy
Induction chemotherapy
Concurrent chemoradiotherapy
Preoperative factors
Dynamic factors
Prognostic Factor

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases