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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Nasopharyngeal Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

3 and 5 years

Safety Issue:

Yes

Principal Investigator

XiaoShen WANG, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Radiation Oncology, Cancer Hospital, Fudan University

Authority:

China: Ethics Committee

Study ID:

NPC20081

NCT ID:

NCT00817583

Start Date:

January 2009

Completion Date:

July 2011

Related Keywords:

  • Nasopharyngeal Carcinoma
  • Phase 2 Clinical Trial
  • NPC
  • neoadjuvant chemotherapy
  • concurrent chemoradiation
  • Carcinoma
  • Nasopharyngeal Neoplasms

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