Status:
RECRUITING
Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
JiangXi Province Tumor Hospital
Fujian Province Tumor Hospital
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 a...
Detailed Description
Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of...
Eligibility Criteria
Inclusion
- Pathologically or clinically confirmed rT3/T4 locally recurrent nasopharyngeal carcinoma;
- No evidence of distant metastasis
- More than 1 year from the end of the first course of radiotherapy
- Male, or female not in the phase of lactating or pregnancy
- ECOG 0-2
- Aged 18-70 years old
- WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
- Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
- Written informed consort signed
Exclusion
- Only regionally recurrence
- Evidence of distant metastasis
- Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
- Severe, active co-morbidity
- Prior anti-tumor treatment after diagnosis of local recurrence
- MRI was not performed 3 months after the first course of radiotherapy
- Abnormal function of heart, brain and lungs, etc
- Lactation or pregnancy
- Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT04136886
Start Date
January 1 2020
End Date
December 1 2027
Last Update
October 23 2019
Active Locations (1)
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1
WangHanYu
Guangzhou, Guangdong, China, 510060