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NCT Number: NCT07741110

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

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.

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Key information

Conditions

Nasopharyngeal Carcinoma (NPC) Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Next generation sequencing

Genetic

Next generation sequencing performed to available paraffin blocks

Immunohistochemistry/CISH

Genetic

Immunohistochemistry and CISH in all available paraffin blocks

Primary outcomes

  1. Risk factors associated with survival

    Time frame: 3 years

Other outcomes

  1. Clinicopathological characteristics associated with survival

    Time frame: 3 years

  2. IHC characteristics associated with survival

    Time frame: 3 years

  3. Next generation sequencing variables associated with survival

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Hellenic Cooperative Oncology Group

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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