Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated TongJi hospital of HuaZhong University of science and Technology; First Hospital of FoShan City; Fujian Province Tumor Hospital; GuiZhou Province Tumor Hospital; Hainan Cancer Hospital; HaiNan Province Tumor Hospital; Hunan Province Tumor Hospital; JiangXi Province Tumor Hospital; Second Affiliated Hospital of Nanchang University; SiChuan Province Tumor Hospital; Tongji Hospital; Wuhan University; YuNan Province Tumor Hospital
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• 1.Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;

2.No evidence of distant metastasis

3.More than 1 year from the end of the first course of radiotherapy

4.Male, or female not in the phase of lactating or pregnancy

5.ECOG 0-2

6.Aged 18-70 years old

7.WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L

8.Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits

9.Written informed consort signed

Exclusion Criteria:

1. Only regionally recurrence

2. Evidence of distant metastasis

3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted

4. Severe, active co-morbidity

5. Prior anti-tumor treatment after diagnosis of local recurrence

6. MRI was not performed 3 months after the first course of radiotherapy

7. Abnormal function of heart, brain and lungs, etc

8. Lactation or pregnancy

9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence