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

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Gemcitabine

Cisplatin

regular intensity-modulated radiotherapy

surgery

Target-reduction intensity-modulated radiotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Surgery, Target-reduction Chemoradiotherapy, Locally Resectable Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting
Fifth Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgery Plus Target-reduction Chemoradiotherapy

Regular Chemoradiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Local Regional Relapse-Free Survival (LRRFS)

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.

Secondary Outcome Measures

Overall Survival (OS)

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.

Progress-free survival (PFS)

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.

Distant Metastasis-Free Survival (DMFS)

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.

Regional Relapse-Free Survival (RRFS)

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.

Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

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.

Incidence of treatment related acute complications

The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

Incidence of treatment related late complications

The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

Full Information

NCT ID

NCT05352321

First Posted

April 18, 2022

Last Updated

June 28, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT05352321

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

June 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Surgery, Target-reduction Chemoradiotherapy, Locally Resectable Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery Plus Target-reduction Chemoradiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Regular Chemoradiotherapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

for induction chemotherapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

for induction and concurrent chemotherapy

Intervention Type

Radiation

Intervention Name(s)

regular intensity-modulated radiotherapy

Intervention Description

in active comparator arm

Intervention Type

Procedure

Intervention Name(s)

surgery

Other Intervention Name(s)

Endoscopic nasopharyngectomy, Retropharyngeal lymphadenectomy, Neck lymph node dissection

Intervention Description

in experimental arm

Intervention Type

Radiation

Intervention Name(s)

Target-reduction intensity-modulated radiotherapy

Intervention Description

in experimental arm

Primary Outcome Measure Information:

Title

Local Regional Relapse-Free Survival (LRRFS)

Description

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.

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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.

Time Frame

3 years

Title

Progress-free survival (PFS)

Description

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.

Time Frame

3 years

Title

Distant Metastasis-Free Survival (DMFS)

Description

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.

Time Frame

3 years

Title

Regional Relapse-Free Survival (RRFS)

Description

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.

Time Frame

3 years

Title

Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

Description

Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

Time Frame

3 years

Title

Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)

Description

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.

Time Frame

3 years

Title

Incidence of treatment related acute complications

Description

The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

Time Frame

1 years

Title

Incidence of treatment related late complications

Description

The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming-yuan Chen, MD, PhD

Phone

02087342422

chmingy@mail.sysu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Rui You, MD, PhD

Phone

13580439820

chmingy@mail.sysu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming-yuan Chen, MD, PhD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming-yuan Chen

Phone

86-20-8734-3361

chmingy@mail.sysu.edu.cn

Facility Name

Fifth Affiliated Hospital of Guangzhou Medical University

City

Guangzhou

State/Province

Guangdong

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiong Zou, MD, PhD

Phone

86-18620249205

zouxiong@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Xiong Zou, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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