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

Brief Title

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

Official Title

Delineation of Reducing Clinical Target Volume for Early-stage Nasopharyngeal

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

LRRFS

Secondary Outcome

 Locoregional failure patterns

Condition

Target Volume Delineation

Intervention

Reducing CTV

Study Arms / Comparison Groups

 reducing CTV

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

Start Date

May 1, 2001

Completion Date

January 1, 2018

Primary Completion Date

October 31, 2006

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT03839602

Organization ID

CTV Delineation in I-II NPC

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

, ,

Verification Date

February 2019