Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Xiayun He, MD118 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

118

Conditions

Nasopharyngeal Carcinoma

Interventions

Reduced Target Delineation and Radiation DosesRADIATION

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Progression-free survival

The time from date of treatment until date of first documented disease progression or death from any cause, assessed up to 5 years.

Time frame: up to 5 years

Secondary Outcomes

Local recurrence-free survival

The time from date of treatment until date of first documented disease recurrence at a local site, assessed up to 5 years.

Time frame: up to 5 years

Regional recurrence-free survival

The time from date of treatment until date of first documented disease recurrence at a regional site, assessed up to 5 years.

Time frame: up to 5 years

Overall survival

The time from date of treatment until date of death due to any cause, assessed up to 5 years.

Time frame: up to 5 years

Distant metastasis-free survival

The time from date of treatment until date of first documented distant metastasis, assessed up to 5 years.

Time frame: up to 5 years

Locoregional failure patterns

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.

Time frame: up to 5 years

Number of participants with acute toxicities

Number of participants with acute toxicities occurred during the chemoradiotherapy according to CTCAE4.0

Data from ClinicalTrials.gov

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