WangHanYu
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
NCT Number: NCT04136886
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Phase 3
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
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 this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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
Time frame: From the beginning the IMRT to 3 year after the end of IMRT
Time frame: From the beginning of IMRT to 3 months after the end of IMRT
Time frame: From 3 months after the end of IMRT to 1 year after the end of IMRT
Contact information is provided by the study sponsor or research team.
Fei Han, doctor
CONTACT
hanyu wang, doctor
CONTACT
Sun Yat-sen University
Other
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)
Acronym: IMRT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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