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Trial Title: Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy

NCT ID: NCT05674305

Condition: Nasopharyngeal Carcinoma

Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin

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: Radiotherapy
Description: IMRT for primary and regional field
Arm group label: Concurrent chemoradiotherapy
Arm group label: Radiotherapy alone

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin 80mg/m2, 21days/cycle, 2 cycles
Arm group label: Concurrent chemoradiotherapy

Summary: The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III. 2. Age 18-70 years. 3. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition). 4. Patients with detectable pre-treatment plasma EBV DNA but undetectable EBV DNA after one cycle neoadjuvant and no EBV DNA rebound during the second and third cycle. 5. ECOG (Eastern Cooperative Oncology Group) score: 0-1 6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L. 7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN. 8. Renal function: serum creatinine <1×ULN. 9. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: 1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I) 2. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. 3. Receiving radiotherapy or chemotherapy or targeted therapy previously 4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. 6. Severe, uncontrolled medical conditions and infections. 7. At the same time using other test drugs or in other clinical trials. 8. Refusal or inability to sign informed consent to participate in the trial. 9. Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan Universtiy Shanghai Cancer Centre

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Hongmei Ying, M.D.

Phone: +8621-64175590

Phone ext: 81400
Email: yinghongmei2011@sina.com

Start date: January 1, 2022

Completion date: January 1, 2027

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05674305

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