TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Comparison of Tomotherapy Versus Intensity-modulated Radiotherapy for Patients With Nasopharyngeal Carcinoma: a Prospective,Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588403
• Other study ID #: IRB-2018-133
• Status: Recruiting
• Start date: July 1, 2018
• Est. completion date: July 31, 2022

Study information

• Verified date: July 2018
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Tomotherapy is a new radiation planning and delivery technology which may allow for delivery of higher radiation doses with less damage to normal tissues. The investigators aim to compare the treatment efficacy and quality of life between tomotherapy and intensity-modulated radiotherapy for patients with nasopharyngeal carcinoma

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.

2. Tumor staged T1-4N0-3M0 (according to the 8th AJCC staging system)

3. Performance status: KPS>70

4. With normal liver function test (ALT, AST <1.5ULN)

5. Renal: creatinine clearance >60ml/min

6. Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L.

7. Written informed consent

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma

2. Age >65 or <18

3. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)

4. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)

5. Patient is pregnant or lactating

6. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Radiation:
• TOMO
Tomotherapy
• IMRT
Intensity modulated radiotherapy

Locations

Country	Name	City	State
China	Xiaozhong Chen	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QoL(quality of life)	Changes in quality of life were assessed by EORTC QLQ-C30	2 years
Secondary	PFS (progression free survival)	from the first day of therapy to the date of disease progression or death from any cause, whichever was first (according the criterion of RECIST 1.1 ).	2 years
Secondary	OS (overall survival)	from the first day of therapy to death or last follow-up	2 years
Secondary	LRRFS(Locoregional failure-free survival)	from the first day of therapy to the date of first locoregional relapse or until the date of the last follow-up visit.	2 years
Secondary	Adverse Events	Participants will be followed for the duration of hospital stay, an expected average of 50 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 4.03 during the chemoradiation and follow-up.	5 years