- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02454673
Therapeutic Individualization for Patients With Locally Advanced Gastric and Gastroesophageal Cancer
Approximation to the Therapeutic Individualization in Patients With Locally Advanced Gastric and Gastroesophageal Cancer Through Modelling and Generation of Predictive Gene Signatures
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universidad de Navarra
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Group A
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Group B
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From date of diagnosis until death, assessed up to 10 years
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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).
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From date of diagnosis until death, assessed up to 10 years
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Disease Free Survival
Time Frame: From date of diagnosis until treatment failure, assessed up to 10 years
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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).
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From date of diagnosis until treatment failure, assessed up to 10 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological Response at the Time of Surgery
Time Frame: Weeks 10 to 28
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Specimen analysis according to TNM classification.
Pathological complete response is defined as no invasive cancer cells in the surgical specimen.
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Weeks 10 to 28
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R0 Resection rate at the Time of Surgery
Time Frame: Weeks 10 to 28
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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.
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Weeks 10 to 28
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Tumor Regression Grade at the Time of Surgery
Time Frame: Weeks 10 to 28
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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.
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Weeks 10 to 28
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Lymph nodes response at the Time of Surgery
Time Frame: Weeks 10 to 28
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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.
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Weeks 10 to 28
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Estimate of TN Change From Baseline to Surgery
Time Frame: Weeks 10 to 28
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Estimate of TN change due to neoadjuvant treatment is defined as the estimate of the evidence of downstaging between baseline and surgery
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Weeks 10 to 28
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Collaborators and Investigators
Investigators
- Principal Investigator: Javier Rodriguez Rodriguez, MD, PhD, Clinica Universidad de Navarra
Publications and helpful links
General Publications
- Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
- Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.
- Xiong BH, Cheng Y, Ma L, Zhang CQ. An updated meta-analysis of randomized controlled trial assessing the effect of neoadjuvant chemotherapy in advanced gastric cancer. Cancer Invest. 2014 Jul;32(6):272-84. doi: 10.3109/07357907.2014.911877. Epub 2014 May 6.
- Carton E, Caldwell MT, McDonald G, Rama D, Tanner WA, Reynolds JV. Specialized intestinal metaplasia in patients with gastro-oesophageal reflux disease. Br J Surg. 2000 Jan;87(1):116-21. doi: 10.1046/j.1365-2168.2000.01322.x.
- Moehler M, Baltin CT, Ebert M, Fischbach W, Gockel I, Grenacher L, Holscher AH, Lordick F, Malfertheiner P, Messmann H, Meyer HJ, Palmqvist A, Rocken C, Schuhmacher C, Stahl M, Stuschke M, Vieth M, Wittekind C, Wagner D, Monig SP. International comparison of the German evidence-based S3-guidelines on the diagnosis and multimodal treatment of early and locally advanced gastric cancer, including adenocarcinoma of the lower esophagus. Gastric Cancer. 2015 Jul;18(3):550-63. doi: 10.1007/s10120-014-0403-x. Epub 2014 Sep 7.
- Lee S, Oh SY, Kim SH, Lee JH, Kim MC, Kim KH, Kim HJ. Prognostic significance of neutrophil lymphocyte ratio and platelet lymphocyte ratio in advanced gastric cancer patients treated with FOLFOX chemotherapy. BMC Cancer. 2013 Jul 22;13:350. doi: 10.1186/1471-2407-13-350.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUN-GCNMEM
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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