Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, Reduced Target Delineation and Radiation Doses, Sequential chemoradiotherapy
Brief summary
To determine the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with locoregionally advanced nasopharyngeal carcinoma
Detailed description
Although concurrent chemoradiation is the standard treatment modality for locally advanced nasopharyngeal carcinoma (NPC), high incidences of distant metastases and severe treatment related toxicities have become an obstacle to be overcome. Besides, a common problem in locally advanced NPC is the narrow gap between the tumor and critical normal structures, which makes dose optimization difficult. Considering that significant tumor shrinkage may occur during induction chemotherapy, and incidences of distant metastases may be reduced by adjuvant chemotherapy, this study was designed to explore the efficacy and safety of sequential chemoradiotherapy with regimen of docetaxel, cisplatin and fluorouracil and reduced target delineation and radiation doses IMRT for patients with locoregionally advanced NPC.
Interventions
RADIATIONReduced Target Delineation and Radiation Doses
The target volumes were delineated according to the treatment protocol defined as follows: the GTV of the primary tumor (GTV-P) included retropharyngeal lymph nodes, considering the common phenomena of integration, and the rest involved lymph nodes that were defined as GTV-N. For the GTV-P, involved retropharyngeal lymph nodes and intracavity lesions were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) were delineated according to the pre-IC volume of the primary lesion as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for GTV-N delineation. The prescribed dose was 66 Gy to tumors above the slices of skull base or below the orapharynx with less than 5 mm retropharyngeal lymph nodes, or 70.4 Gy to tumors in other slices.
Sponsors
Xiayun He, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Drug: TPF regimen comprised docetaxel (60 mg/m2/day, day 1), cisplatin (25 mg/m2/day, days 1-3), and 5-fluorouracil (500 mg/m2/day with a 120-h infusion) Radiotherapy：Reduced Target Delineation
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Histopathologically proven nasopharyngeal carcinoma (WHO type 2 or 3) 2. Stage Ⅲ-ⅣB disease (AJCC/UICC 2010) 3. KPS more than 70 4. Life expectancy of more than 6 months 5. Signed written informed consent 6. Adequate organ function including the following: Absolute neutrophil count (ANC) \>= 1.5 \* 109/l Platelets count \>= 100 \* 109/l Hemoglobin \>= 10 g/dl AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) Total bilirubin \<= 1.5 times institutional ULN Creatinine clearance \>= 50 ml/min Serum creatine \<= 1 times ULN
Exclusion criteria
1. Evidence of distant metastasis 2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region 3. Other previous or concomitant cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma 4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | up to 5 years | The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 5 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regional recurrence-free survival | up to 5 years | The time from date of treatment until date of first documented disease recurrence at a regional site, assessed up to 5 years. |
| Overall survival | up to 5 years | The time from date of treatment until date of death due to any cause, assessed up to 5 years. |
| Distant metastasis-free survival | up to 5 years | The time from date of treatment until date of first documented distant metastasis, assessed up to 5 years. |
| Locoregional failure patterns | up to 5 years | The failures were categorized as occurring inside or outside the high dose target volume, depending on the location of Vrecur: in field if 95% of Vrecur was within the 95% isodose; marginal if 20% to 95% of Vrecur was within the 95% isodose, or outside if less than 20% of Vrecur was inside the 95% isodose. |
| Local recurrence-free survival | up to 5 years | The time from date of treatment until date of first documented disease recurrence at a local site, assessed up to 5 years. |
| Number of participants with late toxicities | up to 5 years | Number of participants with late toxicities occurred from 3 months after completion of radiotherapy to last follow-up visit according to Radiation Therapy Oncology Group radiation morbidity scoring criteria. |
| Changes of tumor volume | 2 weeks after completion of induction chemotherapy | Changes of tumor volume before and after induction chemotherapy |
| Relationship between treatment failure and dose received by target | up to 5 years | Relationship between treatment failure and dose received by target |
| Number of participants with acute toxicities | during treatment | Number of participants with acute toxicities occurred during the chemoradiotherapy according to CTCAE4.0 |
Countries
China
Outcome results
None listed