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NCT Number: NCT03839602

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

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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Key information

Conditions

Target Volume Delineation Carcinoma Early-stage Nasopharyngeal Carcinoma Head and Neck Neoplasms Intensity Modulated Radiation Therapy Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reducing CTV

Radiation

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

Primary outcomes

  1. LRRFS

    Time frame: 5 year

    locoregional recurrence free survival

Secondary outcomes

  1. Locoregional failure patterns

    Time frame: 5 year

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

  2. DMFS

    Time frame: 5 year

    distant metastasis free survival

  3. DSS

    Time frame: 5 year

    disease specific survival

  4. OS

    Time frame: 5 year

    overall survival

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

    Time frame: 3 months after IMRT

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

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

    Time frame: 5 year

    Radiation Therapy Oncology Group radiation morbidity scoring criteria

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal

Important dates

Study start
2001
Primary completion
2006
Study completion
2018
First posted
Feb 15, 2019
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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