Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): a comprehensive analysis by tumour site.
Pierre Blanchard, Bertrand Baujat, Victoria Holostenco...
https://pubmed.ncbi.nlm.nih.gov/21684027/Actively Recruiting
Led by Nanfang Hospital, Southern Medical University · Updated on 2023-06-18
482
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are comparing two types of chemoradiotherapycisplatin-based and carboplatin-basedin patients with locoregionally advanced nasopharyngeal carcinoma NPC. This phase 3 trial focuses on patients with non-keratinizing NPC at specific tumor stages without distant metastasis. The goal is to confirm the value of carboplatin-based treatment in this patient group. Patients are randomly assigned to receive either cisplatin or carboplatin chemotherapy combined with docetaxel before undergoing radical radiotherapy. The investigational group receives docetaxel and carboplatin every three weeks for two cycles before radiotherapy, then carboplatin concurrently with radiotherapy for three cycles. The control group receives docetaxel and cisplatin before radiotherapy, then cisplatin with radiotherapy for three cycles. Treatment doses and schedules are specified for each regimen. Participants will be monitored for their survival without treatment failure over three years, along with other outcomes like distant and locoregional relapse, response rates after treatments, and side effects. Evaluations occur at set intervals after chemotherapy and radiotherapy completion. Safety is assessed in those receiving assigned treatments, with all analyses performed on an intention-to-treat basis. The study duration extends through 2026.
CONDITIONS
Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma
J
Jian Guan, Ph.D.
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Nanfang Hospital, Southern Medical University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 weeks
Participants receive docetaxel and either carboplatin or cisplatin chemotherapy every three weeks for two cycles before starting radiotherapy.
2 chemotherapy visits every three weeks
Duration - Approximately 9 weeks
Participants receive radical radiotherapy combined with carboplatin or cisplatin chemotherapy every three weeks for three cycles during radiotherapy.
3 chemotherapy and radiotherapy visits every three weeks
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor