Clinical trial NCT03015727: Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
Official title: Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Locally Advanced Nasopharyngeal Carcinoma
Keywords: nasopharyngeal carcinoma
Induction chemotherapy
radiotherapy
chemoradiotherapy
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial People's Hospital
name: The Central Hospital of Lishui City
name: Jinhua Central Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Ningbo Medical Center Lihuili Eastern Hospital
name: People's Hospital of Quzhou
First posted: 2017-01-10
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).

Detailed description: In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).

Eligibility criteria: Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
3. No evidence of distant metastasis (M0)
4. Performance status: KPS\>70
5. With normal liver function test (ALT, AST \<1.5ULN)
6. Renal: creatinine clearance \>60ml/min
7. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
8. With controlled blood glucose for diabetes patients
9. Written informed consent
10. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma
2. Age \>65 or \<18
3. With a history of renal disease
4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
5. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
6. Patient is pregnant or lactating
7. Peripheral neuropathy
8. Emotional disturbance

Primary outcomes:
measure: Progress Free Survival (PFS)
timeFrame: 3 years after the inception assignment
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 3 years and 5 years after the inception of the assignment
measure: Adverse Events
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaozhong Chen
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiaozhong Chen
role: STUDY_CHAIR
References: