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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-01

Study Completion Date

2018-01-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Reducing CTV

Intervention Type RADIATION

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

Interventions

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Reducing CTV

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No