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NCT Number: NCT03283293

Target Volume Delineation After NACT in LA-NPCarcinoma Patients Treated With NACT+ CCRT

The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) could be delineated according to the post-NACT tumor position and receive radical radiation dose, while the tumor disappear after NACT could be encompassed in the first clinical target volume (CTV1) and receive high preventive radiation dose. Through this method,it is more likely to achieve the ultimate goal that maximize the chance of cure while minimize the injury of surrounding normal tissues, maintaining organ function and life quality. Therefore, this stage II clinical trial was designed to study the prognosis and locoregional failure patterns of this target volume delineation method in LA-NPC treated with NACT plus CCRT.

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Key information

Conditions

Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms 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

14 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • histologically confirmed NPC;
  • no evidence of distant metastasis;
  • no previous treatment for NPC;
  • stages III-IVb disease according to the staging system of the 6th AJCC/UICC;
  • adequate liver, renal and bone marrow function;
  • Karnofsky Performance Status (KPS) ≥80 scores.

Exclusion criteria

  • fine-needle aspiration biopsy, incisional or excisional biopsy of neck lymph node, or neck dissection prior NACT;
  • disease progression during NACT;
  • presence of distant metastasis;
  • pregnancy or lactation;
  • previous malignancy or other concomitant malignant disease.

Treatment and study plan

Target Volume Delineation after NACT

Radiation

The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) were delineated in accordance with the head and neck magnetic resonance imaging (MRI) and endoscopy, which obtained two weeks after the last cycle of NACT. The first clinical target volume (CTV1) was defined as the GTVnx plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the high-risk sites of microscopic extension, the whole nasopharynx, and the location and extent of the primary tumor before NACT. The second clinical target volume (CTV2) was defined as the CTV1 plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the low-risk sites of microscopic extension, the level of the lymph node located before NACT, and the elective neck area. The prescribed dose to GTVnx, GTVnd, CTV1 and CTV2 were 68Gy/30f, 62-66Gy/30f, 60Gy/30f and 54Gy/30f, respectively.

Primary outcomes

  1. 5-year loco-regional recurrence free survival (LRRFS)

    Time frame: Five years

Secondary outcomes

  1. 5-year local recurrence free survival (LRFS)

    Time frame: Five years

  2. 5-year regional recurrence free survival (RRFS)

    Time frame: Five years

  3. 5-year distant metastasis free survival (DMFS)

    Time frame: Five years

  4. 5-year disease specific survival (DSS)

    Time frame: Five years

  5. 5-year overall survival (OS)

    Time frame: Five years

  6. Locoregional failure patterns

    Time frame: Five years

    The failures were categorized as occurring inside or outside the high dose target volume, depending on the location of Vrecur: "in field" if 95% of Vrecur was within the 95% isodose; "marginal" if 20% to 95% of Vrecur was within the 95% isodose, or "outside" if less than 20% of Vrecur was inside the 95% isodose.

  7. Late toxicities

    Time frame: Five years

    The late toxicities were graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Study on Delineation of the Target Volumes and Determination of the Irradiation Doses in Untreated Nasopharyngeal Carcinoma (NPC) Treated With Intensity Modulated Radiation Therapy (IMRT)

Important dates

Study start
2001
Primary completion
2007
Study completion
2008
First posted
Sep 14, 2017
Registry last updated
Feb 12, 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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