Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

Phase 3

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: IMRT; Drug: Cisplatin

• Registration Number: NCT04136886
• Lead Sponsor: Sun Yat-sen University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Last Update Submitted: 2019-10-22
• Study First Posted: 2019-10-23
• Last Update Posted: 2019-10-23
• Study Start: 2020-01-01
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 346

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMRT alone	IMRT	IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction
IMRT and concurrent cisplatin	IMRT	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 and concurrent cisplatin	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

Primary Outcome Measures

Name	Time	Method
Overall survival	From the beginning the IMRT to 3 year after the end of IMRT

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

WangHanYu; 🇨🇳 Guangzhou, Guangdong, China