A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

NCT04061278 | Unknown Phase 3

• 1 other identifier: SAHZhejiangU-2019-009
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 12

Brief Summary

At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.

Conditions

Nasopharyngeal Carcinoma; Neoadjuvant Chemotherapy

Keywords

Nasopharyngeal Carcinoma; Neoadjuvant Chemotherapy; Concurrent Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

• 5-year overall survival

  the duration between the date of diagnosed and date of patient death

  5 years

• 5-year metastatic free survival

  the duration between the date of diagnosed and date of metastasis

  5 years

Secondary Outcomes (3)

• 5-year disease-free survival

  5 years

• 5-year recurrence-free survival

  5 years

• Safety (incidence of grade 3/4 adverse reactions)

  5 years

Study Arms (2)

4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy

EXPERIMENTAL

Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy

Drug: 4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy

3cycles of Neoadjuvant Chemotherapy With chemoradiotherapy

ACTIVE COMPARATOR

3 cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy

Drug: 3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy

Interventions

4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy DRUG

4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy

4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy

3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy DRUG

3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy

3cycles of Neoadjuvant Chemotherapy With 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:

• Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;
• According to the UICC/AJCC eighth edition staging criteria, clinical staging was T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);
• Patients who have not received disease-related anti-tumor system therapy;
• Age 18\~70 years;
• Perfect liver and kidney function: total bilirubin ≤1.5 times the upper limit of normal value (ULN); AST and ALT≤2.5 ULN; Alkaline phosphatase ≤2.5 ULN; Creatinine clearance rate ≥80 mL/min;
• Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
• Cartesian score ≥70; or ECOG PS 0 or 1
• Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper abdomen CT, ECT and other examinations of the whole body bone.
• Sign the informed consent.

You may not qualify if:

• Patients with distant metastases were identified at the time of diagnosis;
• Patients with severe medical complications, severe organ (heart, lung) dysfunction, or neuropsychiatric disorders at the time of diagnosis;
• Previous cases of other malignancies;Complicated with other malignant tumors;Except for cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other site;
• Use any other investigational drug or participate in another clinical trial with therapeutic intent within 3 months prior to enrollment;
• A woman who is pregnant or lactating;
• Known active HIV or HBV, HCV infection;
• Known to be allergic to drugs that may be used;
• The researchers did not consider participants to be eligible for this study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (12)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

NOT YET RECRUITING

Cancer prevention and treatment center, sun yat-sen university

Guandong, Guangdong, 510060, China

NOT YET RECRUITING

The first affiliated hospital, college of medicinle, Zhejiang University

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310058, China

RECRUITING

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, 311200, China

NOT YET RECRUITING

Jinhua Central Hospital

Jinhua, Zhejiang, 321000, China

NOT YET RECRUITING

Lishui City Central Hospital

Lishui, Zhejiang, 323000, China

NOT YET RECRUITING

Ningbo Yinzhou People's Hospital

Ningbo, Zhejiang, 315000, China

NOT YET RECRUITING

Ningbo No.2 Hospital

Ningbo, Zhejiang, 315010, China

NOT YET RECRUITING

People's Hospital of Quzhou

Quzhou, Zhejiang, 324000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Chemoradiotherapy

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Qichun Wei

  2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

  STUDY CHAIR

Central Study Contacts

Qichun Wei

CONTACT

0571-87783522; qichun_wei@zju.edu.cn

Jing Xu

CONTACT

0571-87783522; shanyefengxu@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 19, 2019
• Study Start: August 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: May 12, 2020

Record last verified: 2019-08

Locations

CN (12)