Trial Title:
Induction Chemotherapy Followed by IMRT or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma
NCT ID:
NCT05527470
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin
Gemcitabine
Conditions: Keywords:
Nasopharyngeal Carcinoma
Chemoradiotherapy
Radiotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Induced Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced
Nasopharyngeal Carcinoma
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine,Cisplatin
Description:
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.
Arm group label:
Induction CT+IMRT Combined Concurrent CT
Arm group label:
Induction CT+IMRT alone
Other name:
Induction chemotherapy regimen
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiation therapy (IMRT)
Description:
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.
Arm group label:
Induction CT+IMRT Combined Concurrent CT
Arm group label:
Induction CT+IMRT alone
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Concurrent chemotherapy: Patients received 100mg/m2 cisplatin intravenously on day 1 to
3, three cycles were administered at intervals of 3 weeks.
Arm group label:
Induction CT+IMRT Combined Concurrent CT
Other name:
Concurrent chemotherapy regimen
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Guilin Medical University
Address:
City:
Guilin
Zip:
541001
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Jiang, PhD
Phone:
+86-773-2882906
Email:
Weijiang@glmc.edu.cn
Facility:
Name:
Wuzhou Red Cross Hospital
Address:
City:
Wuzhou
Zip:
543002
Country:
China
Status:
Recruiting
Contact:
Last name:
Bin Zhang, MD
Phone:
+86-0774-3827268
Email:
304527598@qq.com
Start date:
November 11, 2022
Completion date:
November 11, 2027
Lead sponsor:
Agency:
Wei Jiang
Agency class:
Other
Collaborator:
Agency:
Wuzhou Red Cross Hospital
Agency class:
Other
Collaborator:
Agency:
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Agency class:
Other
Collaborator:
Agency:
Lingshan people's Hospital
Agency class:
Other
Collaborator:
Agency:
Laibin People's Hospital
Agency class:
Other
Collaborator:
Agency:
Nationalities Hospital of Guangxi Zhuang Autonomous Region
Agency class:
Other
Source:
Guilin Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527470
