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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04136886

Acronym

IMRT

Enrollment

346

Registered

2019-10-23

Start date

2020-01-01

Completion date

2027-12-31

Last updated

2019-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

concurrent chemotherapy, IMRT, recurrent NPC

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 alone.

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 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.

Interventions

DRUGCisplatin

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

RADIATIONIMRT

Radiation: IMRT IMRT is to give 60Gy in 27 fraction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall survival	From the beginning the IMRT to 3 year after the end of IMRT

Secondary

Measure	Time frame
Number of participants with severe acute toxicities as assessed by CTCAE v3.0	From the beginning of IMRT to 3 months after the end of IMRT
Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema	From 3 months after the end of IMRT to 1 year after the end of IMRT

Countries

China

Contacts

Primary ContactFei Han, doctor

hanfei@sysucc.org.cn8620-87343030

Backup Contacthanyu wang, doctor

wanghany@sysucc.org.cn8620-87343418

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026