Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.

NCT06529562 | Recruiting DMC

• 1 other identifier: SYSUCC-CMY-20240221
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .

Conditions

Nasopharyngeal Carcinoma

Keywords

Surgery; Target-Reduction Chemoradiotherapy; Dose-Reduction Chemoradiotherapy; Locally Resectable Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Locoregional Recurrence-Free Survival Time (LRRFS)

  The time interval between randomization and locoregional recurrence, or censored at the date of the last follow-up.

  3 years

Secondary Outcomes (6)

• Overall survival (OS)

  3 years

• Incidence of Treatment-Related Adverse Events

  1 years

• Distant Metastasis-Free Survival (DMFS)

  3 years

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

  3 years

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

  3 years

Study Arms (2)

surgery plus target reduction Chemoradiotherapy

ACTIVE COMPARATOR

Surgery: Endoscopic Nasopharyngectomy:Radical Reaction of the Primary Lesion Using Nasal Endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy. Neck lymph node dissection Selection of region where the possitive lymph nodes are located. Intensity modulated radiotherapy with GTV and CTV1 Reduction: CTV2:50.00Gy/25Fr/2.00Gy. Chemotherapy: cisplatin-based regimens.

Radiation: Surgery combined with Target-reduction intensity-modulated radiotherapy

surgery plus dose reduction Chemoradiotherapy

EXPERIMENTAL

Surgery: Endoscopic Nasopharyngectomy: Radical Reaction of the Primary Lesion Using Nasal Endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy. Neck lymph node dissection Selection of region where the possitive lymph nodes are located. Intensity modulated radiotherapy with CTV1 and CTV2 dose Reduction: CTV1：48.00-50.00Gy/20Fr/2.40-2.50Gy； CTV2：40.00Gy/20Fr/2.00Gy. Chemotherapy: cisplatin-based regimens.

Radiation: Surgery combined with Dose-reduction intensity-modulated radiotherapy

Interventions

Surgery combined with Target-reduction intensity-modulated radiotherapy RADIATION

in control arm

Also known as: Target-reduction intensity-modulated radiotherapy

surgery plus target reduction Chemoradiotherapy

Surgery combined with Dose-reduction intensity-modulated radiotherapy RADIATION

in experimental arm

Also known as: Dose-reduction intensity-modulated radiotherapy

surgery plus dose reduction Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, 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) and tumor diameter ≤1.5cm. Resectable retropharyngeal lymph nodes were defined as; The diameter was ≤ 1.5cm, the tissue space was intact, and there was no obvious extranodal invasion; The resectable cervical lymph nodes were defined as ≤ 3cm in diameter, located above the lower edge of the cricoid cartilage, with moderate mobility and no obvious extranodal invasion. Clinical stage: T1-3N1-2M0, T2-3N0M0 (Stage II-III) according to AJCC 8th staging edition.
• 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.

You may not qualify if:

• Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
• Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy or chemotherapy.
• Retropharyngeal lymph node diameter\>1.5cm, or extranodal invasion, such as invasion of internal carotid artery, muscle, or extensive extracapsular dissemination.
• Cervical lymph node diameter\>3cm, or in the area below the lower margin of the cricoid cartilage, or with extranodal invasion, such as invasion of the internal carotid artery, skin, muscle, mediastinal structure, prevertebral fascia or cervical spine, or extensive extra-capsular spread, subcutaneous metastasis, etc.
• 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.

Sponsors & Collaborators

• Ming-Yuan Chen: lead
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-sen University: collaborator
• Fifth Affiliated Hospital of Guangzhou Medical University: collaborator
• Huazhong University of Science and Technology Union Hospital (Nanshan Hospital): collaborator
• The First Affiliated Hospital of University of South China: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Nanchang City First Hospital: collaborator

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Ming-Yuan Chen, MD,PhD

  SUN yet-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yuan Chen, MD,PhD

CONTACT

86-13903052650; chmingy@email.sysu.edu.cn

You-Ping Liu, PhD

CONTACT

86-137517763276; liuyp78@email.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professior

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2032
• Study Completion (Estimated): November 1, 2032
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

CN (1)