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Trial Title:
Two Cycles VS Three Cycles Induction Chemotherapy in T1-4N2-3 Locally Advanced Nasopharyngeal Carcinoma
NCT ID:
NCT05860868
Condition:
Locally Advanced Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
2 cycles induction chemotherapy
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).
Arm group label:
2 cycles
Intervention type:
Drug
Intervention name:
3 cycles induction chemotherapy
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).
Arm group label:
3 cycles
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-65 years old;
2. Pathologically confirmed non-keratinizing nasopharyngeal carcinoma;
3. Stage T3-4N0-1 (according to the UICC/AJCC 8th);
4. No distant metastasis;
5. Have not received anti-cancer treatment in the past;
6. ECOG (Eastern Cooperative Oncology Group of the United States): 0-1;
7. Adequate hematologic, hepatic and renal function.
Exclusion Criteria:
1. The purpose of treatment is palliative;
2. Diagnosed with other malignant tumors at the same time;
3. Malignant tumor history;
4. Pregnancy or breastfeeding, or expect to become pregnant during the clinical trial
period;
5. Combined serious illness.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Recruiting
Contact:
Last name:
Cheng-Tao Wang
Phone:
+862087755766
Email:
wangcht5@mail.sysu.edu.cn
Start date:
May 2023
Completion date:
May 2030
Lead sponsor:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Source:
First Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05860868
