Induction Chemotherapy, Chemoradiotherapy and Surgery in Locally Advanced Gastric Cancer Patients

Surgery Clinical Trial

Official title:

Induction Chemotherapy, Chemo-radiotherapy and Surgery in Locally Advanced Gastric Cancer Patients: Long Term Results From a Single Institution.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454647
• Other study ID #: GC-PKPDGN
• Status: Completed
• Phase: N/A
• First received: May 22, 2015
• Last updated: May 27, 2015
• Start date: September 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Adenocarcinoma
• Digestive System Neoplasms
• Effects of Chemotherapy
• Gastric Cancer
• Gastrointestinal Neoplasms
• Stomach Neoplasms
• Surgery

Intervention

Drug:
• Induction chemotherapy

Radiation:
• Radiotherapy with concurrent chemotherapy

Procedure:
• Salvage surgery

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Overall was defined as the period from diagnosis until death (from any cause).	From date of treatment until death, assessed up to 10 years	No
Primary	Identification of prognostic factors for overall survival	Overall was defined as the period from diagnosis until death (from any cause). Correlation between survival and baseline, clinical and treatment characteristics from patients	From date of treatment until death, assessed up to 10 years	No
Primary	Disease-free survival	Disease-free survival was defined as the time from diagnosis to the first date of local or distant cancer.	From date of diagnosis until progression or death, assessed up to 10 years	No
Primary	R0 resection rate	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.	Week 24 to 28	No
Secondary	Pathological response	Specimen analysis according to TNM classification. Pathological complete response is defined as no invasive cancer cells in the surgical specimen.	Week 24 to 28	No
Secondary	Patterns of treatment failure	Type of recurrence: local, regional and/or distant.	From date of diagnosis until treatment failure, assessed up to 10 years	No
Secondary	Adverse events are assessed according to CTC criteria v 4.0	Safety and tolerability during the neoadjuvant protocol.	Week 1 to 20	Yes