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

Locally Advanced Nasopharyngeal Carcinoma Clinical Trial

— IRCNPC  

Official title:

Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03015727
• Other study ID #: ZhejiangCH 01536224
• Status: Recruiting
• Phase: Phase 3
• First received: December 24, 2016
• Last updated: January 9, 2017
• Start date: December 2016
• Est. completion date: December 2024

Study information

• Verified date: December 2016
• Source: Zhejiang Cancer Hospital
• Contact: Xiaozhong Chen
• Email: cxzfyun[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Locally Advanced Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Docetaxel
3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
• Cisplatin
3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.

Radiation:
• IMRT/TOMO
intensity modulated radiation therapy or tomotherapy

Drug:
• Chemotherapy
2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.

Locations

Country	Name	City	State
China	Xiaozhong Chen	Hangzhou	Zhejiang

Sponsors (7)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	First Affiliated Hospital of Wenzhou Medical Univeristy, Jinhua Central Hospital, Ningbo Medical Center Lihuili Eastern Hospital, Quzhou People’s Hospital, The Central Hospital of Lishui City, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress Free Survival (PFS)	PFS means assignment to the date of any local or distant progress of the disease.	3 years after the inception assignment	No
Secondary	Overall Survival (OS)	The overall survival denote to assignment to date of death from any cause.	3 years and 5 years after the inception of the assignment	No
Secondary	Adverse Events	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.	Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years	Yes