NCT03588403

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 20, 2018

Status Verified

July 1, 2018

Enrollment Period

4.1 years

First QC Date

July 4, 2018

Last Update Submit

July 18, 2018

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • QoL(quality of life)

    Changes in quality of life were assessed by EORTC QLQ-C30

    2 years

Secondary Outcomes (4)

  • PFS (progression free survival)

    2 years

  • OS (overall survival)

    2 years

  • LRRFS(Locoregional failure-free survival)

    2 years

  • Adverse Events

    5 years

Study Arms (2)

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

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

Interventions

TOMORADIATION

Tomotherapy

Arm A:Tomotherapy
IMRTRADIATION

Intensity modulated radiotherapy

Arm B: IMRT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

nasopharyngeal carcinoma patients staged T1-4N0-3M0

You may qualify if:

  • Patients with newly histologically confirmed non-keratinizing carcinoma.
  • Tumor staged T1-4N0-3M0 （according to the 8th AJCC staging system）
  • Performance status: KPS\>70
  • With normal liver function test (ALT, AST \<1.5ULN)
  • Renal: creatinine clearance \>60ml/min
  • Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
  • Written informed consent

You may not qualify if:

  • WHO type I squamous cell carcinoma or adenocarcinoma
  • Age \>65 or \<18
  • Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
  • Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
  • Patient is pregnant or lactating
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xiaozhong Chen

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief phisician

Study Record Dates

First Submitted

July 4, 2018

First Posted

July 17, 2018

Study Start

July 1, 2018

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

July 20, 2018

Record last verified: 2018-07

Locations

CN(1)