Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00817258

Enrollment

Registered

2009-01-06

Start date

2007-01-31

Completion date

2009-12-31

Last updated

2009-01-06

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

Conditions

Nasopharyngeal Carcinoma

Keywords

Phase 2 Clinical Trial, NPC, radiation therapy, chemotherapy

Brief summary

The primary objective of this study is to determine the overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy. Secondary objectives of the study are to evaluate the disease free survival, and distant metastases free survival of patients with stage II NPC treated with this regimen

Detailed description

Radiotherapy alone is the standard treatment for early stage NPC. In retrospective study of early stage NPC patients treated with radiotherapy alone. Patients who had Stage II disease had a worse outcome compared with patients with stage I disease. Chemotherapy, delivered concurrently with radiation therapy, has been adopted as standard treatment for locally advanced NPC. However, concurrent chemoradiation for stage II NPC patients has never been prospectively studied. In the present trial, we hope to assess the value of concurrent chemotherapy and radiotherapy in patients with stage II (T1-2N1) NPC.

Interventions

DRUGcisplatin

Cisplatin 40mg/m2,weekly

RADIATION3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

3D-CRT or IMRT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx. * Stage II disease (T1-2; N1; M0) * KPS \>70 * Age between 18-70 * Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of \> 2000 cells/mm3, platelet count of \> 100,000 cells/mm3 (pre treatment without intervention). Bilirubin \< 1.5 mg/dl, AST or ALT\<2 x upper normal, serum creatinine\<1.5mg/dl, creatinine clearance \>50ml/min. * No prior radiation treatment to the head and neck or any prior chemotherapy * Patients with no prior malignancy (not include basal cell carcinoma of skin)

Exclusion criteria

* Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations. * Prior radiotherapy to the head and neck region for any reason. * Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease. * Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin. * Pregnant women.

Design outcomes

Primary

Measure	Time frame
overall survival	3 and 5 years

Secondary

Measure	Time frame
disease-free survival, and distant metastases free survival	3 and 5 years

Countries

China

Contacts

Primary ContactLin Kong, MD

konglinj@gmail.com8621-64175590

Outcome results

None listed

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