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NCT Number: NCT02454647

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

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.

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Key information

Conditions

Gastric Cancer Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Effects of Chemotherapy Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Stomach Diseases Stomach Neoplasms Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induction chemotherapy

Drug

Radiotherapy with concurrent chemotherapy

Radiation

salvage surgery

Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 27, 2015
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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