Back to results

Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients

Primary Purpose

Target Volume Delineation, Early-stage Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Reducing CTV

About this trial

This is an interventional treatment trial for Target Volume Delineation focused on measuring Locoregional Failure Pattern, Toxicity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Cancer Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

reducing CTV

Arm Description

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.

Outcomes

Primary Outcome Measures

LRRFS

locoregional recurrence free survival

Secondary Outcome Measures

Locoregional failure patterns

To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence

DMFS

distant metastasis free survival

DSS

disease specific survival

overall survival

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

National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)

Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria

Radiation Therapy Oncology Group radiation morbidity scoring criteria

Full Information

NCT ID

NCT03839602

First Posted

February 11, 2019

Last Updated

February 12, 2019

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT03839602

Brief Title

Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients

Official Title

Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

May 1, 2001 (Actual)

Primary Completion Date

October 31, 2006 (Actual)

Study Completion Date

January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

The investigators designed a prospective phase II study for early-stage NPC patients, and proposed a reasonable delineation method of reducing CTV according to the clinical characteristics and tumor infiltration patterns, performing therapeutic dose to tumor and prophylactic dose to CTV while protecting as much normal tissues as possible, in order to ensure a long-term survival with good quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Target Volume Delineation, Early-stage Nasopharyngeal Carcinoma, Intensity Modulated Radiation Therapy

Keywords

Locoregional Failure Pattern, Toxicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

The CTV was divided into CTV1 (high risk) and CTV2 (low risk) according to the biological behavior and characteristics of early-stage NPC.

Masking

None (Open Label)

Allocation

N/A

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

reducing CTV

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Reducing CTV

Intervention Description

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

Primary Outcome Measure Information:

Title

LRRFS

Description

locoregional recurrence free survival

Time Frame

5 year

Secondary Outcome Measure Information:

Title

Locoregional failure patterns

Description

To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence

Time Frame

5 year

Title

DMFS

Description

distant metastasis free survival

Time Frame

5 year

Title

DSS

Description

disease specific survival

Time Frame

5 year

Title

Description

overall survival

Time Frame

5 year

Title

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

Description

National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)

Time Frame

3 months after IMRT

Title

Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria

Description

Radiation Therapy Oncology Group radiation morbidity scoring criteria

Time Frame

5 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

Facility Information:

Facility Name

Cancer Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32272183

Citation

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.

Results Reference

derived

Learn more about this trial

Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal Carcinoma Patients

We'll reach out to this number within 24 hrs