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NCT Number: NCT02454673

Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer

The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Effects of Chemotherapy Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms Surgery

Age range

18 year–85 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 gastroesophageal junction and gastric cancer with T3-4 and/or N+ are included. Initially, patients are diagnosed by computerized tomography scan and endoscopic ultrasound. The neoadjuvant strategy consisted of 3-4 cycles of preoperative chemotherapy (group A) or 3-4 courses of induction chemotherapy followed by concurrent chemoradiotherapy (group B). Chemoradiotherapy comprised 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. Nonlinear mixed effects (NLME) modelling is applied to evaluate the impact of dynamic changes in tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) on the clinical outcome of these patients.

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 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

Treatment and study plan

Primary outcomes

  1. Overall Survival

    Time frame: From date of diagnosis until death, assessed up to 10 years

    Overall survival was defined as the period from diagnosis until death (from any cause). Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).

  2. Disease Free Survival

    Time frame: From date of diagnosis until treatment failure, assessed up to 10 years

    DFS was defined as the time from diagnosis to the first date of local or distant cancer. Nonlinear mixed effects population modelling to evaluate the impact in clinical outcome of dynamic markers as tumor size, neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR).

Secondary outcomes

  1. Pathological Response at the Time of Surgery

    Time frame: Weeks 10 to 28

    Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.

  2. R0 Resection rate at the Time of Surgery

    Time frame: Weeks 10 to 28

    The R0 resection rate after 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.

  3. Tumor Regression Grade at the Time of Surgery

    Time frame: Weeks 10 to 28

    Estimate of tumor regression grade at the time of surgery according to Becker Criteria: Grade 1a, No residual tumor; Grade 1b, <10% residual tumor; Grade 2, 10-50% residual tumor; Grade 3, >50% residual tumor.

  4. Lymph nodes response at the Time of Surgery

    Time frame: Weeks 10 to 28

    Participants were assessed for node-negative lymph nodes at the time of surgery according to TNM classification. Node-negative (pN0) participants had no regional lymph node metastasis.

  5. Estimate of TN Change From Baseline to Surgery

    Time frame: Weeks 10 to 28

    Estimate of TN change due to neoadjuvant treatment is defined as the estimate of the evidence of downstaging between baseline and surgery

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures

Important dates

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