NCT03839602

Brief Summary

To analyze the long-term results and toxicities of the reducing clinical target volume (CTV) delineation method in early-stage nasopharyngeal carcinoma (NPC) patients treated with intensity modulated radiation therapy (IMRT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2006

Completed
11.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5.5 years

First QC Date

February 11, 2019

Last Update Submit

February 12, 2019

Conditions

Target Volume DelineationEarly-stage Nasopharyngeal CarcinomaIntensity Modulated Radiation Therapy

Keywords

Locoregional Failure PatternToxicity

Outcome Measures

Primary Outcomes (1)

  • LRRFS

    locoregional recurrence free survival

    5 year

Secondary Outcomes (6)

  • Locoregional failure patterns

    5 year

  • DMFS

    5 year

  • DSS

    5 year

  • OS

    5 year

  • Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)

    3 months after IMRT

  • +1 more secondary outcomes

Study Arms (1)

reducing CTV

EXPERIMENTAL

The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC. The prescribe doses of GTVnx, GTVnd, CTV1 and CTV2 were 68Gy, 60-66Gy, 60Gy and 50-54Gy in 30 fractions, respectively.

Radiation: Reducing CTV

Interventions

Reducing CTVRADIATION

CTVs were delineated in line with tumor stage, i.e. tumor invasion.

reducing CTV

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed NPC (WHO II-III)
  • stage I-IIb according to the 6th AJCC/UICC
  • no previous treatment for NPC
  • between 18 and 70 years old
  • KPS ≥ 80 scores
  • adequate organ function (white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥ 1.5×109/L; hemoglobin ≥ 100g/L; platelet count ≥ 100×109/L; total bilirubin, aspartate aminotransferase and alanine aminotransferase ≤ 1.5X upper limit normal; and creatinine clearance rate ≥ 30 mL/min)

You may not qualify if:

  • fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT
  • disease progression during IMRT
  • presence of distant metastasis
  • pregnancy or lactation
  • previous malignancy or other concomitant malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

  • Miao J, Di M, Chen B, Wang L, Cao Y, Xiao W, Wong KH, Huang L, Zhu M, Huang H, Huang S, Han F, Deng X, Xiang Y, Lv X, Xia W, Tan SH, Wee JTS, Guo X, Chua MLK, Zhao C. A Prospective 10-Year Observational Study of Reduction of Radiation Therapy Clinical Target Volume and Dose in Early-Stage Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Jul 15;107(4):672-682. doi: 10.1016/j.ijrobp.2020.03.029. Epub 2020 Apr 6.

    PMID: 32272183DERIVED

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
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

February 11, 2019

First Posted

February 15, 2019

Study Start

May 1, 2001

Primary Completion

October 31, 2006

Study Completion

January 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

CN(1)