Clinical trial NCT00817583: Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)
Official title: Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Phase 2 Clinical Trial
NPC
neoadjuvant chemotherapy
concurrent chemoradiation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) and concurrent chemoradiation.

Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage III,IVa, IVb NPC treated with this regimen.

The third objective of this study is to evaluate who may benifit from this treatment regimen.

Detailed description: Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.

Eligibility criteria: Inclusion Criteria:

* -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
* Stage Ⅲ, IVa and IVb 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.
* the primary tumor or involved lymph node must be more than 2CM in diameter.
* 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

Primary outcomes:
measure: overall survival
timeFrame: 3 and 5 years
Secondary outcomes:
measure: distant metastases free survival , and disease-free survival
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Radiation Oncology, Cancer Hospital, Fudan University
name: XiaoShen WANG, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Cancer Hospital, Fudan University
name: ChaoSu HU, M.D.
role: STUDY_CHAIR
affiliation: Department of Radiation Oncology, Cancer Hospital, Fudan University
name: ChunYing Shen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Cancer Hospital, Fudan University
name: HongMei Ying, M.D.
role: PRINCIPAL_INVESTIGATOR
References: