Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMRT and concurrent cisplatin

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

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

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

IMRT

Intervention Type RADIATION

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

IMRT alone

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

Group Type EXPERIMENTAL

IMRT

Intervention Type RADIATION

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

Interventions

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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

Intervention Type DRUG

IMRT

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

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No