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New treatment option for Nasopharyngeal Carcinoma
Official title Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT05979961
What this study is testing
What is gemcitabine and cisplatin (Induction chemotherapy)?
gemcitabine and cisplatin (Induction chemotherapy) is an investigational medicine, given as an once-daily, being studied as a potential treatment for nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).
- Phase 3: a large, late-stage study
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 years old.
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
- Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
- ECOG Performance status less or equal to 1.
- Male and no pregnant female.
You likely can't join if
- Patients have evidence of relapse or distant metastasis.
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent.
- History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
See the full eligibility criteria
- Age 18-70 years old.
- Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
- Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
- ECOG Performance status less or equal to 1.
- Male and no pregnant female.
- Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) \< 2.5×ULN, and bilirubin \< ULN.
- Adequate renal function: creatinine clearance ≥ 60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
- Patients have evidence of relapse or distant metastasis.
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent.
- History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhongshan, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Wuhan, Hubei, China
- Changsha, Hunan, 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; Zhongshan, Guangdong, China; Nanning, Guangxi, China; Guiyang, Guizhou, China; Wuhan, Hubei, China; Changsha, Hunan, 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.