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

NCT07741110 | Completed DMC

• 1 other identifier: ΗΕ_5Ν/03
• Study Type: observational
• Target: 141
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

nasopharyngeal carcinoma; next generation sequencing; immunohistochemistry; CISH

Outcome Measures

Primary Outcomes (1)

• Risk factors associated with survival

  3 years

Other Outcomes (3)

• Clinicopathological characteristics associated with survival

  3 years

• IHC characteristics associated with survival

  3 years

• Next generation sequencing variables associated with survival

  3 years

Study Arms (2)

Induction chemotherapy followed by cisplatin-based chemoradiotherapy

Induction chemotherapy: 3 cycles of epirubicin 75 mg/m2 followed by paclitaxel 175 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 2. Each cycle is repeated every 3 weeks. Followed by RT concomitant with cisplatin 40 mg/m2 weekly, 1-2 h before RT

Cisplatin-based chemoradiotherapy

RT concomitant with cisplatin 40 mg/m2 weekly, 1-2 h before RT

Interventions

Next generation sequencing GENETIC

Next generation sequencing performed to available paraffin blocks

Immunohistochemistry/CISH GENETIC

Immunohistochemistry and CISH in all available paraffin blocks

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced nasopharyngeal carcinoma

You may qualify if:

• 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.

You may not qualify if:

• Secondary malignancies
• age\< 15 years
• ECOG PS 3-4
• Renal, hepatic, hematologic or pulmonary insufficiency

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin blocks

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start: October 1, 2003
• Primary Completion: February 28, 2008
• Study Completion: February 28, 2008
• Last Updated: August 3, 2026

Record last verified: 2025-01