Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma
Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)
Sun Yat-sen University
346 participants
Jan 1, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- 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 Criteria9
- 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
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Interventions
cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction
Radiation: IMRT IMRT is to give 60Gy in 27 fraction
Locations(1)
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NCT04136886