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

Intensity Modulated Radiation Therapy Clinical Trial

Official title:

Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839602
• Other study ID #: CTV Delineation in I-II NPC
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2001
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: January 1, 2018
• Est. primary completion date: October 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. histologically confirmed NPC (WHO II-III)

2. stage I-IIb according to the 6th AJCC/UICC

3. no previous treatment for NPC

4. between 18 and 70 years old

5. KPS = 80 scores

6. 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:

1. fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior IMRT

2. disease progression during IMRT

3. presence of distant metastasis

4. pregnancy or lactation

5. previous malignancy or other concomitant malignant disease

Related Conditions & MeSH terms

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

Intervention

Radiation:
• Reducing CTV
CTVs were delineated in line with tumor stage, i.e. tumor invasion.

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LRRFS	locoregional recurrence free survival	5 year
Secondary	Locoregional failure patterns	To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence	5 year
Secondary	DMFS	distant metastasis free survival	5 year
Secondary	DSS	disease specific survival	5 year
Secondary	OS	overall survival	5 year
Secondary	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)	3 months after IMRT
Secondary	Late toxicity assessed with Radiation Therapy Oncology Group radiation morbidity scoring criteria	Radiation Therapy Oncology Group radiation morbidity scoring criteria	5 year