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

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05860868

Collaborator

(none)

474

Enrollment

Location

Arms

Anticipated Duration (Months)

5.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Nasopharyngeal Carcinoma	Drug: 2 cycles induction chemotherapy Drug: 3 cycles induction chemotherapy	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

474 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2028

Anticipated Study Completion Date :

May 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 cycles 2 cycles induction + concurrent chemoradiotherapy	Drug: 2 cycles induction chemotherapy 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).
Active Comparator: 3 cycles 3 cycles induction + concurrent chemoradiotherapy	Drug: 3 cycles induction chemotherapy 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).

Arm

Intervention/Treatment

Experimental: 2 cycles

2 cycles induction + concurrent chemoradiotherapy

Drug: 2 cycles induction chemotherapy

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).

Active Comparator: 3 cycles

3 cycles induction + concurrent chemoradiotherapy

Drug: 3 cycles induction chemotherapy

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).

Outcome Measures

Primary Outcome Measures

FFS, Failure Free Survival [3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Other (Non U.s.)	China	510080

Sponsors and Collaborators

First Affiliated Hospital, Sun Yat-Sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chen Yong, Prof., First Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT05860868

Other Study ID Numbers:

Two VS Three

First Posted:

May 16, 2023

Last Update Posted:

May 16, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma

Nasopharyngeal Carcinoma

Study Results

No Results Posted as of May 16, 2023