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Nasopharyngeal CarcinomaNCT05352321

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

A study testing Gemcitabine, Cisplatin and regular intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Nasopharyngeal Carcinoma
What is being tested?
Gemcitabine, Cisplatin and regular intensity-modulated radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
2 sitesChina
Study dates
1 Jun 2022to 1 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ming-yuan Chen, MD, PhD contact

02087342422

chmingy@mail.sysu.edu.cn

Rui You, MD, PhD contact

13580439820

chmingy@mail.sysu.edu.cn

China2 sites, 2 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Ming-yuan Chen, 86-20-8734-3361, chmingy@mail.sysu.edu.cn

    Recruiting

  • Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Xiong Zou, MD, PhD, 86-18620249205, zouxiong@sysucc.org.cn

    Xiong Zou, MD,PhD

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Gemcitabine, Cisplatin, regular intensity-modulated radiotherapy, surgery, Target-reduction intensity-modulated radiotherapy
Keywords
Surgery, Target-reduction Chemoradiotherapy, Locally Resectable Nasopharyngeal Carcinoma
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    for induction chemotherapy

  • CisplatinDrug

    for induction and concurrent chemotherapy

  • regular intensity-modulated radiotherapyRadiation

    in active comparator arm

  • surgeryProcedure or surgery

    Also called Endoscopic nasopharyngectomy, Retropharyngeal lymphadenectomy, Neck lymph node dissection

    in experimental arm

  • Target-reduction intensity-modulated radiotherapyRadiation

    in experimental arm

Study groups in NCT05352321
Study groupRoleWhat they receive
Surgery Plus Target-reduction ChemoradiotherapyExperimentalSurgery: 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
Receives: Drug: Gemcitabine; Drug: Cisplatin; Procedure: surgery; Radiation: Target-reduction intensity-modulated radiotherapy
Regular ChemoradiotherapyActive comparatorInduction 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
Receives: Drug: Gemcitabine; Drug: Cisplatin; Radiation: regular intensity-modulated radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

Secondary outcomes (8)

  1. 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.

    Measured: 3 years

  2. 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.

    Measured: 3 years

  3. 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.

    Measured: 3 years

  4. 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.

    Measured: 3 years

  5. 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.

    Measured: 3 years

  6. 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.

    Measured: 3 years

  7. Incidence of treatment related acute complications

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

    Measured: 1 years

  8. Incidence of treatment related late complications

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start1 Jun 2022
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352321
Sponsor's protocol ID
SYSUCC-CMY-2022-122-01
Status last verified
Jun 2022
First submitted
18 Apr 2022
Last updated
1 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Gemcitabine, Cisplatin and regular intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ming-yuan Chen, MD, PhD (02087342422, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Regional Relapse-Free Survival (LRRFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352321.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022; AzTrials last refreshed its copy on 3 Nov 2026.

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