TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: IMRT; Radiation: TOMO

• Registration Number: NCT03588403
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study Start: 2018-07-01
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-17
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-20
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm B: IMRT	IMRT	Patients with non-disseminated nasopharyngeal carcinoma receiving IMRT.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.
Arm A:Tomotherapy	TOMO	Patients with non-disseminated nasopharyngeal carcinoma receiving Tomotherapy.The prescribed radiation dose was defined as follows: PGTVnx 7040cGy/32F,PGTVnd 7040cGy/32F,PTV1 6080cGy/32F,PTV2 5440cGy/32F.

Primary Outcome Measures

Name	Time	Method
QoL(quality of life)	2 years	Changes in quality of life were assessed by EORTC QLQ-C30

Secondary Outcome Measures

Name	Time	Method
Adverse Events	5 years	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.
PFS (progression free survival)	2 years	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 ).
OS (overall survival)	2 years	from the first day of therapy to death or last follow-up
LRRFS(Locoregional failure-free survival)	2 years	from the first day of therapy to the date of first locoregional relapse or until the date of the last follow-up visit.

Trial Locations

Locations (1)

Xiaozhong Chen; 🇨🇳 Hangzhou, Zhejiang, China