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Genes in Predicting Outcome in Patients With Esophageal Cancer Treated With Cisplatin, Radiation Therapy, and Surgery

Single Nucleotide Polymorphisms (SNP) in Platinum-/Radiation Pathway Genes to Predict Outcome in Patients With Esophageal Adenocarcinoma Treated With Cisplatin-Based Chemoradiotherapy Followed by Surgical Resection

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00898495
Enrollment
118
Registered
2009-05-12
Start date
2007-05-11
Completion date
2008-12-31
Last updated
2020-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, stage I esophageal cancer

Brief summary

RATIONALE: Studying samples of tissue in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment. PURPOSE: This laboratory study is looking at genes to see if they can predict outcome in patients with esophageal cancer treated with cisplatin, radiation therapy, and surgery.

Detailed description

OBJECTIVES: * Correlate patient outcomes with neoplastic cell genotypes, specifically 18 single nucleotide polymorphisms (SNPs) in 16 major genes involved in platinum metabolism and disposition and DNA repair, in patients with esophageal cancer treated with neoadjuvant cisplatin-based chemoradiotherapy followed by surgical resection on clinical trial ECOG-1201. * Correlate patient outcomes with neoplastic cell genotypes, specifically loss of heterozygosity, in these patients. * Correlate patient outcomes with normal (germline) cell genotypes, specifically SNPs related to platinum metabolism and disposition and DNA repair. * Compare the predictive ability of neoplastic vs germline cell genotypes. OUTLINE: This is a retrospective, cohort, multicenter study. Neoplastic and normal (germline) cells are collected from pretreatment and post-treatment specimens using laser-capture microdissection. Single nucleotide polymorphisms are examined by real-time PCR. Loss of heterozygosity is assessed by analyzing short tandem repeat markers in neoplastic and germline tissue.

Interventions

GENETICpolymerase chain reaction
GENETICpolymorphism analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
ECOG-ACRIN Cancer Research Group
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of the esophagus * Stage I-IV disease * Received cisplatin-based treatment on clinical trial ECOG-1201 PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Design outcomes

Primary

MeasureTime frame
Comparison of pretreatment clinical tumor staging vs post-treatment pathologic staging (at resection)1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026