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NCT Number: NCT04136886

Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

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.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cisplatin

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

Radiation

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

Primary outcomes

  1. Overall survival

    Time frame: From the beginning the IMRT to 3 year after the end of IMRT

Secondary outcomes

  1. Number of participants with severe acute toxicities as assessed by CTCAE v3.0

    Time frame: From the beginning of IMRT to 3 months after the end of IMRT

  2. Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema

    Time frame: From 3 months after the end of IMRT to 1 year after the end of IMRT

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Han, doctor

CONTACT

[email protected]

8620-87343030

hanyu wang, doctor

CONTACT

[email protected]

8620-87343418

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • First Hospital of FoShan City
  • Fujian Province Tumor Hospital
  • GuiZhou Province Tumor Hospital
  • Hainan Cancer Hospital
  • Hunan Province Tumor Hospital
  • JiangXi Province Tumor Hospital
  • Second Affiliated Hospital of Nanchang University
  • SiChuan Province Tumor Hospital
  • Tongji Hospital
  • Wuhan University
  • YuNan Province Tumor Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Oct 23, 2019
Registry last updated
Oct 23, 2019

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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