Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
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|ClinicalTrials.gov Identifier: NCT02454647|
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : May 28, 2015
|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|
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|
|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|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
- 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).
- 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
- 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.
- 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.
- 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.
- 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.
- 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
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): NCT02454647
|Clinica Universidad de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Principal Investigator:||javier Rodriguez Rodriguez, MD, PhD||CUN|