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

Clinical and Biomarker Analysis Data From a Previously Pubished Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07741110

Enrollment

141

Registered

2026-08-03

Start date

2003-10-01

Completion date

2008-02-28

Last updated

2026-08-03

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

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

nasopharyngeal carcinoma, next generation sequencing, immunohistochemistry, CISH

Brief summary

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.

Detailed description

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.

Interventions

GENETICNext generation sequencing

Next generation sequencing performed to available paraffin blocks

GENETICImmunohistochemistry/CISH

Immunohistochemistry and CISH in all available paraffin blocks

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Risk factors associated with survival	3 years

Outcome results

None listed

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