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Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Locally Advanced Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
2 cycles induction chemotherapy
3 cycles induction chemotherapy
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-65 years old; Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; Stage T3-4N0-1 (according to the UICC/AJCC 8th); No distant metastasis; Have not received anti-cancer treatment in the past; ECOG (Eastern Cooperative Oncology Group of the United States): 0-1; Adequate hematologic, hepatic and renal function. Exclusion Criteria: The purpose of treatment is palliative; Diagnosed with other malignant tumors at the same time; Malignant tumor history; Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period; Combined serious illness.

Sites / Locations

  • First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2 cycles

3 cycles

Arm Description

2 cycles induction + concurrent chemoradiotherapy

3 cycles induction + concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

FFS, Failure Free Survival
Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2023
Last Updated
May 6, 2023
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05860868
Brief Title
Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
Official Title
Two Cycles VS Three Cycles Induction Chemotherapy Plus Concurrent Chemoradiotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2028 (Anticipated)
Study Completion Date
May 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This trial is a multi-center phase III clinical trial. The purpose of this trial is to explore whether 2 cycles induction chemotherapy combined with concurrent chemoradiotherapy is not inferior to 3 cycles induction chemotherapy combined with concurrent chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
474 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2 cycles
Arm Type
Experimental
Arm Description
2 cycles induction + concurrent chemoradiotherapy
Arm Title
3 cycles
Arm Type
Active Comparator
Arm Description
3 cycles induction + concurrent chemoradiotherapy
Intervention Type
Drug
Intervention Name(s)
2 cycles induction chemotherapy
Intervention Description
Drug: 2 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w. Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w. Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).
Intervention Type
Drug
Intervention Name(s)
3 cycles induction chemotherapy
Intervention Description
Drug: 3 cycles Induction Chemotherapy Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w. Drug: Concurrent Chemotherapy Cisplatin 100 mg/m², Q3w. Radiation: Definitive Radiotherapy For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).
Primary Outcome Measure Information:
Title
FFS, Failure Free Survival
Description
Defined as the time from randomization to tumor recurrence, distant metastasis, or death due to any reason, whichever occurs first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 years old; Pathologically confirmed non-keratinizing nasopharyngeal carcinoma; Stage T3-4N0-1 (according to the UICC/AJCC 8th); No distant metastasis; Have not received anti-cancer treatment in the past; ECOG (Eastern Cooperative Oncology Group of the United States): 0-1; Adequate hematologic, hepatic and renal function. Exclusion Criteria: The purpose of treatment is palliative; Diagnosed with other malignant tumors at the same time; Malignant tumor history; Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial period; Combined serious illness.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Tao Wang
Phone
+862087755766
Email
wangcht5@mail.sysu.edu.cn
Facility Information:
Facility Name
First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Other (Non U.s.)
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Tao Wang
Phone
+862087755766
Email
wangcht5@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma

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