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

Brief Title

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

Official Title

A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study Comparing 4 Cycles of Neoadjuvant Chemotherapy Combined With Radiotherapy Versus 3cycles of Neoadjuvant Chemotherapy Combined With Concurrent Chemoradiotherapy for the Treatment of N2-3 Nasopharyngeal Carcinoma

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

5-year overall survival

Secondary Outcome

 5-year disease-free survival

Condition

Nasopharyngeal Carcinoma

Intervention

4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy

Study Arms / Comparison Groups

 4 Cycles of Neoadjuvant Chemotherapy With Radiotherapy

Description:  Four cycles of neoadjuvant chemotherapy combined with radical radiotherapy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

August 1, 2019

Completion Date

December 31, 2022

Primary Completion Date

June 30, 2022

Eligibility Criteria

Inclusion Criteria:

1. Non-keratinizing nasopharyngeal carcinoma diagnosed by pathology;

2. According to the UICC/AJCC eighth edition staging criteria, clinical staging was
T1-4N2 -3M0 (stage N2-3 nasopharyngeal carcinoma);

3. Patients who have not received disease-related anti-tumor system therapy;

4. Age 18~70 years;

5. 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;

6. Complete blood system function: neutrophil count (ANC) ≥2×109/L, platelet count
≥100×109/L and hemoglobin ≥9 g/dL;

7. Cartesian score ≥70; or ECOG PS 0 or 1

8. Prior to enrollment, the patients must undergo nasopharynx + neck MRI, chest + upper
abdomen CT, ECT and other examinations of the whole body bone.

9. Sign the informed consent.

Exclusion Criteria:

1. Patients with distant metastases were identified at the time of diagnosis;

2. Patients with severe medical complications, severe organ (heart, lung) dysfunction, or
neuropsychiatric disorders at the time of diagnosis;

3. 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;

4. Use any other investigational drug or participate in another clinical trial with
therapeutic intent within 3 months prior to enrollment;

5. A woman who is pregnant or lactating;

6. Known active HIV or HBV, HCV infection;

7. Known to be allergic to drugs that may be used;

8. The researchers did not consider participants to be eligible for this study.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Qichun Wei, 0571-87783522, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04061278

Organization ID

SAHZhejiangU-2019-009

Responsible Party

Sponsor

Study Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Sponsor

Qichun Wei, Study Chair, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Verification Date

August 2019