Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma

June 28, 2022 updated by: Ming-Yuan Chen, Sun Yat-sen University

Multicenter Randomized Controlled Trial of Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma

Through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Fifth Affiliated Hospital of Guangzhou Medical University
        • Contact:
        • Principal Investigator:
          • Xiong Zou, MD,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Performance Status Score 0-1 points.
  • Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
  • Patients with primary nasopharyngeal lesions evaluated as surgically resectable before chemotherapy, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus or pterygoid process). Clinical stage: T1-3N1-3M0, T2-3N0M0 (Stage II-IVA) according to AJCC v8.
  • Patients with cervical lymph nodes evaluated as surgically resectable before chemotherapy, including cervical lymph nodes with no invasion (encasement) of the common or ICA, the epidermis, mediastinal structures, prevertebral fascia, or cervical vertebrae.
  • Patients with retropharyngeal lymph nodes evaluated as surgically resectable before chemotherapy, including simple RPLNs with intact capsule or RPLNs ≤ 1.5cm with mouth opening range > 4cm.
  • Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
  • Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.

Exclusion Criteria:

  • Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
  • Suffering severe cardiopathy or pulmonary dysfunction with cardiac or pulmonary function no more than grade 3.
  • Extensive recurrent primary tumour beyond the resectable area such as extensive invasion of the skull base or a distance from the tumour margins to the internal carotid artery of less than 0·5 cm.
  • Retropharyngeal lymph node involved or adjacent to primary nasopharyngeal lesions (less than 0·5 cm).
  • Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
  • During pregnancy or lactation.
  • Other patients that the chief physician considered as illegal for this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery Plus Target-reduction Chemoradiotherapy

Surgery:

Endoscopic nasopharyngectomy: Radical resection of primary lesion using nasal endoscopy.

Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs resection using nasal endoscopy or da Vinci robotics.

Neck lymph node dissection: Selective neck dissection of the region where the positive lymph nodes are located.

Induction Chemotherapy for stage III-IVa:

Gemcitabine, 1000 mg/m2, Day 1 and Day 8, Q3W, 3 cycles Cisplatin, 80 mg/m2, Day 1, Q3W, 3 cycles

Intensity-modulated Radiotherapy with GTV and CTV1 reduction:

CTV2 : 54.12Gy/33Fr/1.64Gy

Concurrent Chemotherapy:

Cisplatin, 100 mg/m2, intravenously, Day 1, Q3W during radiotherapy

for induction chemotherapy
for induction and concurrent chemotherapy
in experimental arm
Other Names:
  • Endoscopic nasopharyngectomy
  • Retropharyngeal lymphadenectomy
  • Neck lymph node dissection
in experimental arm
Active Comparator: Regular Chemoradiotherapy

Induction Chemotherapy for stage III-IVa:

Gemcitabine, 1000 mg/m2, intravenously within 30min, Day 1 and Day 8, Q3W, 3 cycles Cisplatin, 80 mg/m2, intravenously, Day 1, Q3W, 3 cycles

Intensity-modulated Radiotherapy:

GTVnx (nasopharyngeal lesions): 69.96Gy/33Fr/2.12Gy GTVrnd (retropharyngeal lymph nodes): 69.96Gy/33Fr/2.12Gy GTVnd: 69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82Gy CTV2: 54.12Gy/33Fr/1.64Gy

Concurrent Chemotherapy:

Cisplatin, 100 mg/m2, intravenously, Day 1, Q3W during radiotherapy

for induction chemotherapy
for induction and concurrent chemotherapy
in active comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Regional Relapse-Free Survival (LRRFS)
Time Frame: 3 years
The LRRFS is evaluated and calculated from the date of random assignment until the day of first local regional relapse or until the date of the last follow-up visit.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 3 years
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
3 years
Distant Metastasis-Free Survival (DMFS)
Time Frame: 3 years
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit.
3 years
Progress-free survival (PFS)
Time Frame: 3 years
Progress-free survival is calculated from the date of randomization to the date of the first progression of any site or death or censored at the date of the last follow-up.
3 years
Regional Relapse-Free Survival (RRFS)
Time Frame: 3 years
The RRFS was defined as the duration from the date of random assignment to the date of regional relapse or censored at the date of the last follow-up.
3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time Frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time Frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.
3 years
Incidence of treatment related acute complications
Time Frame: 1 years
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
1 years
Incidence of treatment related late complications
Time Frame: 3 years
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

June 1, 2028

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 24, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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