NCT02454673

Brief Summary

The purpose of this study is to evaluate whether the R0 rate, pathological response degree, patterns of recurrence and long-term outcomes may be initially predicted in patients with locally advanced gastroesophageal junction and gastric cancer treated with a neoadjuvant approach and salvage surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 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 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1.5 years

First QC Date

May 22, 2015

Last Update Submit

May 26, 2015

Conditions

Gastric CancerEffects of ChemotherapySurgery

Keywords

RadiotherapyNeoadjuvant therapyPharmacodynamicsPharmacokineticsNonlinear Dynamics

Outcome Measures

Primary Outcomes (2)

  • Overall Survival

    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).

    From date of diagnosis until death, assessed up to 10 years

  • Disease Free Survival

    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).

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

Secondary Outcomes (5)

  • Pathological Response at the Time of Surgery

    Weeks 10 to 28

  • R0 Resection rate at the Time of Surgery

    Weeks 10 to 28

  • Tumor Regression Grade at the Time of Surgery

    Weeks 10 to 28

  • Lymph nodes response at the Time of Surgery

    Weeks 10 to 28

  • Estimate of TN Change From Baseline to Surgery

    Weeks 10 to 28

Study Arms (2)

Group A

* 3-4 cycles of preoperative chemotherapy * Surgery

Group B

* 3-4 cycles of induction chemotherapy * Radiotherapy with concurrent chemotherapy for 5 weeks * Surgery

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (6)

  • 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.

    PMID: 16822992BACKGROUND

  • 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.

    PMID: 24800782BACKGROUND

  • 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.

    PMID: 19139439BACKGROUND

  • 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.

    PMID: 10606922BACKGROUND

  • 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.

    PMID: 25192931BACKGROUND

  • 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.

    PMID: 23876227BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Surgical specimen with potential for extraction of DNA.

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Javier Rodriguez Rodriguez, MD, PhD

    Clinica Universidad de Navarra

    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 27, 2015

Record last verified: 2015-03

Locations

ES(1)