Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma

Phase 3

Recruiting

• Conditions: Locally Advanced Nasopharyngeal Carcinoma
• Interventions: Drug: Docetaxel; Drug: Cisplatin; Radiation: IMRT/TOMO; Drug: Chemotherapy

• Registration Number: NCT03015727
• Lead Sponsor: Zhejiang Cancer Hospital

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).

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-24
• Study First Submitted QC: 2017-01-09
• Last Update Submitted: 2017-01-09
• Study First Posted: 2017-01-10
• Last Update Posted: 2017-01-10
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IC+RT group	IMRT/TOMO	3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
IC+CCRT group	IMRT/TOMO	3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
IC+CCRT group	Chemotherapy	3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
IC+RT group	Docetaxel	3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
IC+RT group	Cisplatin	3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
IC+CCRT group	Docetaxel	3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
IC+CCRT group	Cisplatin	3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.

Primary Outcome Measures

Name	Time	Method
Progress Free Survival (PFS)	3 years after the inception assignment	PFS means assignment to the date of any local or distant progress of the disease.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	3 years and 5 years after the inception of the assignment	The overall survival denote to assignment to date of death from any cause.
Adverse Events	Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years	Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE (3rd edition) during the neoadjuvant chemotherapy, chemoradiation and follow-up.

Trial Locations

Locations (1)

Xiaozhong Chen; 🇨🇳 Hangzhou, Zhejiang, China