Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

NCT05527470 | Recruiting Phase 3 DMC

• 1 other identifier: GLMU-08
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief Summary

In the era of comprehensive therapy, many studies have investigated the value of induction chemotherapy (IC) in the treatment of nasopharyngeal carcinoma (NPC). Concurrent cisplatin and radiotherapy is the foundation of concurrent chemoradiotherapy strategies, and the addition of cisplatin-based induction chemotherapy to concurrent chemoradiotherapy (CCRT) is considered to prolong survival by reducing distant metastasis in patients with high-risk disease. However, the severity of acute toxicities was significantly increased, which can compromise quality of life and lead to interruptions in CCRT. Fortunately, Locoregional control has substantially improved as the intensity-modulated radiation therapy (IMRT) technique has been widely used in the last decades, IMRT improved the treatment outcomes of patients with NPC, especially the local control rate. Currently, in the era of IMRT, whether patients with NPC benefit from IC plus radiotherapy alone and reduce toxicities compared with IC combined with CCRT. Therefore, the investigators propose this randomized phase III prospective study to assess the efficacy and contribution of IC plus radiotherapy alone in locoregionally advanced NPC during IMRT era.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Chemoradiotherapy; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free survival is from randomization to first disease progression \[local recurrence and/or distant metastasis\] or death from any cause

  3 years

Secondary Outcomes (5)

• Overall Survival

  3 years

• Locoregional Failure-free Survival

  3 years

• Distant Failure-free Survival

  3 years

• Objective response rate

  3 years

• Number of Participants with Adverse Events

  3 years

Study Arms (2)

Induction CT+IMRT Combined Concurrent CT

ACTIVE COMPARATOR

Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy

Drug: Gemcitabine,Cisplatin; Radiation: Intensity-modulated radiation therapy (IMRT); Drug: Cisplatin

Induction CT+IMRT alone

EXPERIMENTAL

Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone

Drug: Gemcitabine,Cisplatin; Radiation: Intensity-modulated radiation therapy (IMRT)

Interventions

Gemcitabine,Cisplatin DRUG

Induction chemotherapy: Patients receive 1000 mg/m2 gemcitabine intravenously on day 1and day 8， 80mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.

Also known as: Induction chemotherapy regimen

Induction CT+IMRT Combined Concurrent CT; Induction CT+IMRT alone

Intensity-modulated radiation therapy (IMRT) RADIATION

IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were \> 66 Gy to the primary tumor and \> 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.

Induction CT+IMRT Combined Concurrent CT; Induction CT+IMRT alone

Cisplatin DRUG

Concurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.

Also known as: Concurrent chemotherapy regimen

Induction CT+IMRT Combined Concurrent CT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);
• Tumor staged as III-IVb (according to the 8th AJCC edition);
• No pregnant female;
• Age between 18-65;
• Normal complete blood count level (hemoglobin \>10 g/dL, white blood cells ≥4000/μL, platelets ≥100 000/μL);
• Normal hepatic functions (serum total bilirubin ≤1.6 mg/dL, serum transminase \< 2.5 times higher than upper limit);
• Normal renal function (serum creatinine ≤1.5 mg/dL, creatinine clearance ≥60 mL/min);
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Without radiotherapy or chemotherapy;
• Patients must give signed informed consent.

You may not qualify if:

• Disease progression in the process of the treatment;
• The presence of uncontrolled life-threatening illness;
• History of previous radiotherapy or chemotherapy;
• Pregnancy or lactation.

Sponsors & Collaborators

• Wei Jiang: lead
• Wuzhou Red Cross Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Lingshan people's Hospital: collaborator
• Laibin People's Hospital: collaborator
• Nationalities Hospital of Guangxi Zhuang Autonomous Region: collaborator

Study Sites (2)

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, 541001, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, 543002, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine; Cisplatin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Wei Jiang, PhD

CONTACT

+86-2882906; weijiang@glmc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Induced Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 2, 2022
• Study Start: November 11, 2022
• Primary Completion: November 11, 2025
• Study Completion (Estimated): November 11, 2027
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

CN (2)