Clinical trial NCT02454647: Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients
Official title: Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Adenocarcinoma
Effects of Chemotherapy
Surgery
Gastrointestinal Neoplasms
Keywords: Radiotherapy
Neoadjuvant therapy
Induction chemotherapy
Concurrent chemoradiotherapy
Preoperative factors
Dynamic factors
Prognostic Factor
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
First posted: 2015-05-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced adenocarcinoma of the stomach treated with a neoadjuvant protocol consisting of induction chemotherapy (ICT), chemoradiotherapy (CRT)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 ICT and CRT.

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.

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival
timeFrame: From date of treatment until death, assessed up to 10 years
measure: Identification of prognostic factors for overall survival
timeFrame: From date of treatment until death, assessed up to 10 years
measure: Disease-free survival
timeFrame: From date of diagnosis until progression or death, assessed up to 10 years
measure: R0 resection rate
timeFrame: Week 24 to 28
Secondary outcomes:
measure: Pathological response
timeFrame: Week 24 to 28
measure: Patterns of treatment failure
timeFrame: From date of diagnosis until treatment failure, assessed up to 10 years
measure: Adverse events are assessed according to CTC criteria v 4.0
timeFrame: Week 1 to 20
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: CUN
name: javier Rodriguez Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: