Trial | NCT04136886  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    346
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.
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.
Study Started
Jan 01
2020
Anticipated
Primary Completion
Dec 31
2027
Anticipated
Study Completion
Dec 31
2027
Anticipated
Last Update
Oct 23
2019

Drug Cisplatin

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

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

IMRT and concurrent cisplatin Active Comparator

IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction

IMRT alone Experimental

IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction

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:

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
No Results Posted