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Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer

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ClinicalTrials.gov Identifier: NCT02454673
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary:
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.

Condition or disease
Gastric Cancer Effects of Chemotherapy Surgery

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures
Study Start Date : September 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Group/Cohort
Group A
  • 3-4 cycles of preoperative chemotherapy
  • Surgery
Group B
  • 3-4 cycles of induction chemotherapy
  • Radiotherapy with concurrent chemotherapy for 5 weeks
  • Surgery



Primary Outcome Measures :
  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 Outcome Measures :
  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


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


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with locally advanced adenocarcinoma gastric cancer for a neoadjuvant protocol consisting of preoperative chemotherapy or induction chemotherapy, chemoradiotherapy 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 chemotherapy and chemoradiotherapy.

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.

Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT02454673


Locations
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
Principal Investigator: Javier Rodriguez Rodriguez, MD, PhD Clinica Universidad de Navarra

Publications:

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT02454673     History of Changes
Other Study ID Numbers: CUN-GCNMEM
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: March 2015

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Radiotherapy
Neoadjuvant therapy
Pharmacodynamics
Pharmacokinetics
Nonlinear Dynamics

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases