Nasopharyngeal Carcinoma
Conditions
Keywords
Radiotherapy, chemotherapy, Drug Targeting, loco-regionally advanced nasopharyngeal carcinoma, Safety., efficacy
Brief summary
This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.
Interventions
DRUGC225 (cetuximab)
one week before and then weekly during radiotherapy
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sichuan Cancer Hospital and Research Institute
Fujian Cancer Hospital
Fudan University
Cancer Hospital of Guizhou Province
First Affiliated Hospital of Guangxi Medical University
Central South University
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent form signed prior to study entry * Age between 18-69 years old * Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ) * Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria * Primary tumor measurable * KPS score ≥80 * Expected life span ≥6 months * Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L * Adequate liver function: ALAT/ASAT\<1.5 × upper limit of normal (ULN), bilirubin \<1.5×ULN * Adequate renal function: Creatinine Clearance \< 1.5×ULN
Exclusion criteria
* Evidence of distant metastatic disease * Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) * Previous radiotherapy for the primary tumor or lymph nodes * Previous exposure to epidermal growth factor-targeted therapy * Prior chemotherapy or immunotherapy for the primary tumor * Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix * Any investigational agent prior to the 1st study medication * Participation in another clinical study within the 30 days prior to Inclusion in this study. * Peripheral neuropathy \> grade 1 * Known grade 3 or 4 allergic reaction to any of the study treatment * History of severe pulmonary or cardiac disease * Creatinine Clearance \< 30ml/min * Know drug abuse / alcohol abuse * Legal incapacity or limited legal capacity * Active systemic infection * Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study * Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol * Pregnancy (confirmed by serum or urine β-HCG) or lactation period * Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy | 3 months | The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria. |
Secondary
| Measure | Time frame |
|---|---|
| 1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival | 5 year |
Countries
China
Participant flow
Recruitment details
2008-7-1 \ 2009-4-3
Participants by arm
| Arm | Count |
|---|---|
| Cetuximab 400mg/m\^2 intravenous infusion one week before radiotherapy, then 250mg/m\^2 intravenous infusion weekly during radiotherapy | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Cetuximab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants |
| Age Continuous | 43 Years |
| Region of Enrollment China | 100 participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy
The response status (Complete Response + Partial Response) was evaluated according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria. Complete response was defined as disappearance of all target lesions, and Partial response was defined as at least a 30% reduction in the sum of the longest diameter of target lesions, taking as reference the baseline study. Adverse events of this combined modality treatment were graded according to CTCAE (Common Terminology Criteria for Adverse Events) v3.0 criteria.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cetuximab | 3 Month Loco-regional Control After Cetuximab With Concurrent Chemoradiotherapy | 100 participants with loco-regional control |
Secondary
1,3,5 Year Loco-regional Control Rate, 1 Year Progression-free Survival and Metastasis-free Survival, 3 and 5 Year Overall Survival
Time frame: 5 year