Clinical trial NCT03389295: Reduced Target Delineation and Radiation Doses Chemoradiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Official title: Sequential Chemoradiotherapy With Reduced Target Delineation and Radiation Doses During Radiotherapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Reduced Target Delineation and Radiation Doses
Sequential chemoradiotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 118
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
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival
timeFrame: up to 5 years
Secondary outcomes:
measure: Local recurrence-free survival
timeFrame: up to 5 years
measure: Regional recurrence-free survival
timeFrame: up to 5 years
measure: Overall survival
timeFrame: up to 5 years
measure: Distant metastasis-free survival
timeFrame: up to 5 years
measure: Locoregional failure patterns
timeFrame: up to 5 years
measure: Number of participants with acute toxicities
timeFrame: during treatment
measure: Number of participants with late toxicities
timeFrame: up to 5 years
measure: Changes of tumor volume
timeFrame: 2 weeks after completion of induction chemotherapy
measure: Relationship between treatment failure and dose received by target
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
citation: Xue F, Ou D, Ou X, Zhou X, Hu C, He X. Long-term results of the phase II dose and volume de-escalation trial for locoregionally advanced nasopharyngeal carcinoma. Oral Oncol. 2022 Nov;134:106139. doi: 10.1016/j.oraloncology.2022.106139. Epub 2022 Sep 27.