NCT02454647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

May 22, 2015

Last Update Submit

May 27, 2015

Conditions

Gastric CancerAdenocarcinomaEffects of ChemotherapySurgeryGastrointestinal Neoplasms

Keywords

RadiotherapyNeoadjuvant therapyInduction chemotherapyConcurrent chemoradiotherapyPreoperative factorsDynamic factorsPrognostic Factor

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Secondary Outcomes (3)

  • Pathological response

    Week 24 to 28

  • Patterns of treatment failure

    From date of diagnosis until treatment failure, assessed up to 10 years

  • Adverse events are assessed according to CTC criteria v 4.0

    Week 1 to 20

Interventions

Induction chemotherapyDRUG
Radiotherapy with concurrent chemotherapyRADIATION
Salvage surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Surgical specimen with potential for extraction of DNA.

MeSH Terms

Conditions

Stomach NeoplasmsAdenocarcinomaGastrointestinal Neoplasms

Interventions

Induction ChemotherapyRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsRemission Induction

Study Officials

  • javier Rodriguez Rodriguez, MD, PhD

    CUN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

May 27, 2015

Study Start

September 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

ES(1)