TOMO Versus IMRT in Nasopharyngeal Carcinoma Patients

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

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

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Radiation: TOMO; Radiation: IMRT

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Xiaozhong Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

nasopharyngeal carcinoma patients staged T1-4N0-3M0

Description

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.

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm A:Tomotherapy; 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.	Radiation: TOMO; Tomotherapy
Arm B: 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.	Radiation: IMRT; Intensity modulated radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoL(quality of life)	Changes in quality of life were assessed by EORTC QLQ-C30	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
OS (overall survival)	from the first day of therapy to death or last follow-up	2 years
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
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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: July 4, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma
• Other Study ID Numbers: IRB-2018-133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No