Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma

Phase ⅡStudy of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00816816

Enrollment

Registered

2009-01-05

Start date

2007-02-28

Completion date

2010-06-30

Last updated

2009-01-05

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, neoadjuvant chemotherapy, concurrent chemoradiation

Brief summary

The primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅣAB NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation. Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage ⅣAB treated with this regimen

Detailed description

Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. In the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage ⅣAB NPC.

Interventions

DRUGdocetaxel, cisplatin, fluorouracil

neoadjuvant chemotherapy: docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. concurrent chemotherapy:cisplatin 40 mg/m2 weekly.

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 ⅣAB disease * 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
distant metastases free survival, and disease-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