Biomarker Analysis Data From a Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma Treated With Chemotherapy and Radiotherapy

Hellenic Cooperative Oncology Group141 enrolled

Overview

Clinicopathological and genomic data (Next generation sequencing and IHC/CISH) in available tissues were performed in patients with nasopharyngeal carcinoma who participated in a previously conducted randomized phase II study that evaulated induction chemotherapy followed by CCRT with CCRT alone.

The study seeks to retrospectively evaluate next generation sequencing and immunohistochemistry data/CISH data performed in all available paraffin blocks from patients with locally advanced nasopharyngeal carcinoma who participated in a previously published randomized phase II study (H 5/03). H 5/03 prospectively compared induction chemotherapy with the regimen CEP followed by concomitant chemoradiotherapy versus concomitant chemoradiotherapy.

Study Type

OBSERVATIONAL

Enrollment

141

Conditions

Nasopharyngeal Carcinoma (NPC)

Interventions

Next generation sequencingGENETIC

Next generation sequencing performed to available paraffin blocks

Immunohistochemistry/CISHGENETIC

Immunohistochemistry and CISH in all available paraffin blocks

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * biopsy-proven, previously untreated WHO type I, II or III NPC; * age \> or equal to 15 years * stage IIB-IVB according to the American Joint Committee on Staging of Cancer classification (AJCC 2002); * measurable or evaluable disease * no other primary tumors * performance status (PS) of 0-2 according to the Eastern Cooperative Oncology Group scale (ECOG) * adequate bone marrow, hepatic, renal and pulmonary function * adequate nutritional status to tolerate protocol treatment and * adequate mental status to follow instructions, keep appointments and provide written informed consent. Exclusion Criteria: * Secondary malignancies * age\< 15 years * ECOG PS 3-4 * Renal, hepatic, hematologic or pulmonary insufficiency

Outcomes

Primary Outcomes

Risk factors associated with survival

Time frame: 3 years

Data from ClinicalTrials.gov

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