Comparing chemotherapy alone to chemotherapy plus radiation for low-risk nasopharyngeal carcinoma

Concurrent Chemoradiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Low-risk Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

This study is testing whether adding a specific type of chemotherapy before radiation helps people with low-risk nasopharyngeal carcinoma live longer and feel better compared to just using radiation with chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 8 sites (Guangzhou, Guangdong and 7 other locations)
• Trial ID: NCT05979961 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of concurrent chemoradiotherapy (CCRT) alone versus the combination of induction chemotherapy followed by CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma (NPC). Participants will be randomly assigned to receive either CCRT alone or induction chemotherapy with gemcitabine and cisplatin before CCRT. The primary endpoint is progression-free survival, while secondary endpoints include overall survival, locoregional progression, distant progression, and assessment of toxic effects. The study will utilize intensity-modulated radiotherapy (IMRT) alongside the chemotherapy regimens.

Who should consider this trial

Good fit: Ideal candidates are males aged 18-70 with newly confirmed non-keratinizing nasopharyngeal carcinoma at stages III-IVa and low EBV DNA levels.

Not a fit: Patients with evidence of relapse, distant metastasis, or keratinizing squamous cell carcinoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into more effective treatment options for patients with low-risk nasopharyngeal carcinoma, potentially improving survival rates.

How similar studies have performed: Other studies have shown promising results with similar chemotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Age 18-70 years old.
2. Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).
3. Tumor staged as III-IVa except T4N2/AnyTN3 (according to the 8th AJCC edition) and pretreatment plasm EB Virus DNA\<4000copies/ml.
4. ECOG Performance status less or equal to 1.
5. Male and no pregnant female.
6. Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL.
7. 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.
8. Adequate renal function: creatinine clearance ≥ 60 ml/min.
9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

1. Patients have evidence of relapse or distant metastasis.
2. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
3. Treatment with palliative intent.
4. History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume).
5. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
6. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
7. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
8. 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 control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.

Where this trial is running

Guangzhou, Guangdong and 7 other locations

• Guangzhou Panyu Central Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Zhongshan City People's Hospital — Zhongshan, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Not_yet_recruiting)
• Cancer Hospital of Guizhou Province — Guiyang, Guizhou, China (Not_yet_recruiting)
• Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Union Hospital, Tongji Medical College,Huazhong University of Science and Technology; — Wuhan, Hubei, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Hai-Qiang Mai

Conditions Nasopharyngeal Carcinoma; Induction Chemotherapy; Concurrent Chemotherapy