Nasopharyngeal Carcinoma (NPC)NCT07741110
Biomarker Analysis Data From a Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma Treated With Chemotherapy and Radiotherapy
An observational study of Nasopharyngeal Carcinoma (NPC), run by Hellenic Cooperative Oncology Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Next generation sequencing and Immunohistochemistry/CISH
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2003to 28 Feb 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with locally advanced nasopharyngeal carcinoma
Who may be able to join
- 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)
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- 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.
Who cannot join
- Secondary malignancies
- age< 15 years
- ECOG PS 3-4
- Renal, hepatic, hematologic or pulmonary insufficiency
About this study
Official title: Clinical and Biomarker Analysis Data From a Previously Pubished Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma
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.
Read the 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.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Next generation sequencing, Immunohistochemistry/CISH
- Keywords
- nasopharyngeal carcinoma, next generation sequencing, immunohistochemistry, CISH
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next generation sequencingGenetic
Next generation sequencing performed to available paraffin blocks
Immunohistochemistry/CISHGenetic
Immunohistochemistry and CISH in all available paraffin blocks
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors associated with survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Oct 2003
- Primary completion28 Feb 2008
- Study completion28 Feb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741110
- Sponsor's protocol ID
- ΗΕ_5Ν/03
- Status last verified
- Jan 2025
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biomarker Analysis Data From a Previously Pubished Randomized Phase II Study in Patients With Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07741110
- Acronym / sponsor ID
- ΗΕ_5Ν/03
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- nasopharyngeal carcinoma, next generation sequencing, immunohistochemistry, CISH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Hellenic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- 1 Oct 2003 (actual)
- Primary completion
- 28 Feb 2008 (actual)
- Study completion
- 28 Feb 2008 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with locally advanced nasopharyngeal carcinoma
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Secondary malignancies
- age< 15 years
- ECOG PS 3-4
- Renal, hepatic, hematologic or pulmonary insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next generation sequencingNext generation sequencing performed to available paraffin blocks | Genetic | – |
| Immunohistochemistry/CISHImmunohistochemistry and CISH in all available paraffin blocks | Genetic | – |
Primary outcome
Risk factors associated with survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma (NPC), run by Hellenic Cooperative Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors associated with survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.