Clinical trial NCT00817258: Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
Official title: Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Phase 2 Clinical Trial
NPC
radiation therapy
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2009-01-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: 3 and 5 years
Secondary outcomes:
measure: disease-free survival, and distant metastases free survival
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Radiation Oncology, Cancer Hospital, Fudan University
Study officials:
affiliation: Department of Radiation Oncology, Cancer Hospital, Fudan University
name: Lin Kong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiation Oncology, Cancer Hospital, Fudan University
name: Chaosu Hu, MD
role: PRINCIPAL_INVESTIGATOR
References: