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

April 30, 2023 updated by: Wei Jiang

A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before 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. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before 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. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 3 cycles during IMRT.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangxi
      • Guilin, Guangxi, China, 541001
        • Recruiting
        • Affiliated Hospital of Guilin Medical University
        • Contact:
      • Wuzhou, Guangxi, China, 543002
        • Recruiting
        • Wuzhou Red Cross Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction CT+IMRT alone
Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone
Radiation: Intensity-modulated radiation therapy (IMRT)
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.
Drug: Gemcitabine,Cisplatin
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.
Other Names:
  • Induction chemotherapy regimen
Active Comparator: Induction CT+IMRT Combined Concurrent CT
Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy
Radiation: Intensity-modulated radiation therapy (IMRT)
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.
Drug: Gemcitabine,Cisplatin
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.
Other Names:
  • Induction chemotherapy regimen
Drug: Cisplatin
Concurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to 3, three cycles were administered at intervals of 3 weeks.
Other Names:
  • Concurrent chemotherapy regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: 3 years
Progression-free survival is from randomization to first disease progression [local recurrence and/or distant metastasis] or death from any cause
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events
Time Frame: 3 years
Incidence of acute and late toxicity
3 years
Overall Survival
Time Frame: 3 years
Overall survival is from randomization to death of any cause or last follow-up
3 years
Locoregional Failure-free Survival
Time Frame: 3 years
Locoregional failure-free survival is from randomization to locoregional progression
3 years
Distant Failure-free Survival
Time Frame: 3 years
Distant failure-free survival is from randomization to first distant metastasis
3 years
Objective response rate
Time Frame: 3 years
Objective response rate is the percentage of patients achieving complete response (CR) and partial response (PR) according to RECIST 1.1 criteria.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Jiang

Collaborators

Wuzhou Red Cross Hospital
Laibin People's Hospital
Lingshan people's Hospital
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Nationalities Hospital of Guangxi Zhuang Autonomous Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2022

Primary Completion (Anticipated)

November 11, 2025

Study Completion (Anticipated)

November 11, 2027

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 30, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLMU-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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