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Compares treatment options for Nasopharyngeal Cancinoma (NPC)
Official title Reduced Dose Radiotherapy vs Standard Dose Radiotherapy for Early Stage Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT06912698
What this study is testing
- What it's testing
- This study investigates whether administering reduced dose is non-inferior to standard dose radiotherapy in terms of 3-year locoregional relapse-free survival (LRRFS) rate for stage I nasopharyngeal carcinoma patients who are sensitive to radiotherapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70, regardless of sex.
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th...
- Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.
- ECOG (Eastern Cooperative Oncology Group) score: 0-1.
- Women in their reproductive years should ensure that they use contraception during the study period.
You likely can't join if
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
- Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.
- Receiving radiotherapy or chemotherapy or targeted therapy previously.
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on...
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
See the full eligibility criteria
- Age 18-70, regardless of sex.
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, clinical stage I (according to the 9th American Joint Committee on Cancer[AJCC] edition).
- Patients with CR according to RECIST and EBV DNA undetectable after received 50.88Gy radiation.
- ECOG (Eastern Cooperative Oncology Group) score: 0-1.
- Women in their reproductive years should ensure that they use contraception during the study period.
- Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
- Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.5×ULN.
- Renal function: serum creatinine \<1.5×ULN or creatinine clearance rate≥60mL/min.
- 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.
- Histologically confirmed keratinizing squamous cell carcinoma (WHO I).
- Patients with PR/SD/PD according to RECIST and/or EBV DNA detectable after received 50.88Gy radiation.
- Receiving radiotherapy or chemotherapy or targeted therapy previously.
- 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.
- Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
- Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
- Severe, uncontrolled medical conditions and infections.
- At the same time using other test drugs or in other clinical trials.
- Refusal or inability to sign informed consent to participate in the trial.
- Other treatment contraindications.
- Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.