Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)

Nasopharyngeal Carcinoma Clinical Trial

— TPF for NPC  

Official title:

Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00817583
• Other study ID #: NPC20081
• Secondary ID: NPC20081NPC20081
• Status: Not yet recruiting
• Phase: Phase 2
• First received: January 5, 2009
• Last updated: January 26, 2009
• Start date: January 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2009
• Source: Fudan University
• Contact: ChaoSu HU, M.D.
• Phone: 86-21-64175590
• Email: hucsu62[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.

• Stage ?, 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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

Radiation:
• 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 and 5 years	Yes
Secondary	distant metastases free survival , and disease-free survival		3 and 5 years	Yes