Clinical Target Volume Based on Disease Extension Risk Atlas and Computer-aided Delineation in Nasopharyngeal Carcinoma

NCT02627807 | Unknown

• 1 other identifier: 2012011
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare individualized clinical target volume (CTV) based on disease extension risk atlas and computer-aided delineation with traditional CTV in intensity modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC), in order to confirm the efficacy and safety.

Conditions

Nasopharyngeal Neoplasms

Keywords

Nasopharyngeal carcinoma; Intensity modulated radiotherapy; Clinical target volume; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Local-regional recurrence-free survival rate

  Local-regional recurrence-free survival is calculated from the date of randomization to the date of local or regional recurrence, whichever is first.

  3-year

Secondary Outcomes (7)

• Overall survival rate

  3-year

• Distant metastasis-free survival rate

  3-year

• Constituent ratio of local and regional recurrence pattern

  3-year

• Number of participants with adverse events

  3-year

• Quality of life score measured by EORTC QLQ-C30

  3-year

Study Arms (2)

Individualized CTV

EXPERIMENTAL

Patients receive IMRT using individualized CTV based on disease extension risk atlas and computer-aided delineation. Gemcitabine and cisplatin induction chemotherapy or docetaxel and cisplatin induction chemotherapy and cisplatin 100mg/m² concurrent chemotherapy or cisplatin 80mg/m² concurrent chemotherapy are optional based on clinical classification.

Radiation: IMRT using individualized CTV; Drug: Gemcitabine and cisplatin (induction chemotherapy); Drug: Docetaxel and cisplatin (induction chemotherapy); Drug: Cisplatin 100mg/m² concurrent chemotherapy; Drug: Cisplatin 80mg/m² concurrent chemotherapy

Traditional CTV

ACTIVE COMPARATOR

Patients receive IMRT using traditional CTV. Gemcitabine and cisplatin induction chemotherapy or docetaxel and cisplatin induction chemotherapy and cisplatin 100mg/m² concurrent chemotherapy or cisplatin 80mg/m² concurrent chemotherapy are optional based on clinical classification.

Radiation: IMRT using traditional CTV; Drug: Gemcitabine and cisplatin (induction chemotherapy); Drug: Docetaxel and cisplatin (induction chemotherapy); Drug: Cisplatin 100mg/m² concurrent chemotherapy; Drug: Cisplatin 80mg/m² concurrent chemotherapy

Interventions

IMRT using individualized CTV RADIATION

Intensity modulated radiotherapy (IMRT) using individualized CTV based on disease extension risk atlas and computer-aided delineation is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.

Individualized CTV

IMRT using traditional CTV RADIATION

Intensity modulated radiotherapy(IMRT) using traditional CTV is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.

Traditional CTV

Gemcitabine and cisplatin (induction chemotherapy) DRUG

Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who participate in another randomized trial (NCT01872962) at the same time receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy.

Also known as: Gemcitabine and cisplatin (GP)

Individualized CTV; Traditional CTV

Docetaxel and cisplatin (induction chemotherapy) DRUG

Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who haven't participated in other trials receive docetaxel (75 mg/m² d1) and cisplatin (75mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles before radiotherapy.

Also known as: Docetaxel and cisplatin (TP)

Individualized CTV; Traditional CTV

Cisplatin 100mg/m² concurrent chemotherapy DRUG

Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC. Patients who participate another clinical trial (NCT01872962) at the same time receive cisplatin (100mg/m² d1) every 3 weeks for 3 cycles concurrently with radiotherapy.

Also known as: DDP 100mg/m²

Individualized CTV; Traditional CTV

Cisplatin 80mg/m² concurrent chemotherapy DRUG

Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC.Patients who haven't participated in other trials receive cisplatin (80mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles concurrently with radiotherapy.

Also known as: DDP 80mg/m²

Individualized CTV; Traditional CTV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
• Tumor staged as T1-4N0-3M0 (according to the 7th AJCC edition), based upon the following minimum diagnostic workup within 4 weeks prior to registration:(1) history/physical examination;(2)chest X-ray, PA and lateral OR chest CT OR PET/CT;(3) pre-treatment magnetic resonance imaging (MRI) of nasopharynx and neck, pre-treatment MRI must be done at Sun Yat-sen University Cancer Center;(4) sonography OR CT of upper abdoman OR PET/CT;(5) Bone scan OR PET/CT.
• Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
• Adequate bone marrow function based upon the complete blood count within 2 weeks prior to registration: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
• Adequate hepatic function within 2 weeks prior to registration: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN.
• Adequate renal function within 2 weeks prior to registration: serum creatinine ≤ 133 umol/L or calculated creatinine clearance ≥ 60 ml/min.
• Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study.
• Patients must be informed of the investigational nature of this study and sign a written informed consent.

You may not qualify if:

• Age \> 65 or \< 18.
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer outside head and neck region, in situ cervical cancer.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
• History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
• Prior chemotherapy or surgery (except fine needle aspiration biopsy) to primary tumor or nodes.
• Hearing loss due to sensorineural deafness（except tumor induced conductive hearing loss).
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), emotional disturbance, untreated active infectious disease, and acquired immune deficiency syndrome.
• Prior allergic reaction to the study drugs involved in this protocol.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

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MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Cisplatin; Induction Chemotherapy; Docetaxel

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Drug Therapy; Therapeutics; Remission Induction; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ying Sun, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician，Deputy director,Assistant dean

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)