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

Phase 2

Completed

• Conditions: Early-stage Nasopharyngeal Carcinoma; Target Volume Delineation; Intensity Modulated Radiation Therapy
• Interventions: Radiation: Reducing CTV

• Registration Number: NCT03839602
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2001-05-01
• Primary Completion: 2006-10-31
• Study Completion: 2018-01-01
• Status Verified: 2019-02
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-12
• Last Update Submitted: 2019-02-12
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
reducing CTV	Reducing CTV	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.

Primary Outcome Measures

Name	Time	Method
LRRFS	5 year	locoregional recurrence free survival

Secondary Outcome Measures

Name	Time	Method
DMFS	5 year	distant metastasis free survival
DSS	5 year	disease specific survival
OS	5 year	overall survival
Acute toxicity assessed with National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (NCI-CTCAE v3.0)	3 months after IMRT	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	5 year	Radiation Therapy Oncology Group radiation morbidity scoring criteria
Locoregional failure patterns	5 year	To identify the locoregional failure patterns: in-field recurrence, marginal recurrence and out-field recurrence

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China