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NCT Number: NCT05352321

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gemcitabine

Drug

for induction chemotherapy

Cisplatin

Drug

for induction and concurrent chemotherapy

regular intensity-modulated radiotherapy

Radiation

in active comparator arm

Surgery

Procedure

in experimental arm

Other names: Endoscopic nasopharyngectomy, Retropharyngeal lymphadenectomy, Neck lymph node dissection

Target-reduction intensity-modulated radiotherapy

Radiation

in experimental arm

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming-yuan Chen, MD, PhD

CONTACT

[email protected]

02087342422

Rui You, MD, PhD

CONTACT

[email protected]

13580439820

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Apr 28, 2022
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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