Phase Ⅲ Trial of Adjuvant Chemotherapy in Patients With N2-3 Nasopharyngeal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-30

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To see the effect if a combination of concurrent chemoradiotherapy followed by different adjuvant chemotherapy in treating patients with N2-3 nasopharyngeal carcinoma(NPC).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

TPF+CCRT vs.CCRT+PF in High Risk Nasopharyngeal Carcinoma

NCT03306121

Nasopharyngeal Carcinoma

ACTIVE_NOT_RECRUITING PHASE3

A Trial On 4 Cycles Of Neoadjuvant Chemotherapy Plus Concurrent Chemoradiation In N2-3 Nasopharyngeal Carcinoma

NCT02512315

Nasopharyngeal Carcinoma

UNKNOWN PHASE3

Neoadjuvant Therapy of GP Chemotherapy Combined With Tislelizumab in Locoregionally Advanced NPC

NCT04833257

Nasopharyngeal Carcinoma

COMPLETED PHASE2

Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma

NCT05979961

Nasopharyngeal Carcinoma

RECRUITING PHASE3

GP Induction Chemotherapy us TPF Adjuvant Chemotherapy Combined With DDP Concurrent Chemoradiotherapy in the Treatment of Locally Advanced NPC

NCT03604965

Locally Advanced Nasopharyngeal Carcinoma

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This phase Ⅲ trial is studying how well radiation therapy and chemotherapy work in treating patients with newly diagnosed N2-3 nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil or cisplatin and gemcitabine, work in different ways (concurrent chemoradiotherapy followed by different adjuvant chemotherapy) to stop the growth of tumor cells.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasopharyngeal Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Cancer Center of Guangzhou Medical University
2. The Affiliated Hospital of Guizhou Medical University, Guizhou Cancer Hospital
3. The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CCRT+GP

Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during radiotherapy followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21days for three cycles

Group Type EXPERIMENTAL

CCRT+GP

Intervention Type DRUG

Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21 days for three cycles 4 weeks after radiotherapy.

CCRT+PF

Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during radiotherapy followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles

Group Type ACTIVE_COMPARATOR

CCRT+PF

Intervention Type DRUG

Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles 4 weeks after radiotherapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CCRT+PF

Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles 4 weeks after radiotherapy.

Intervention Type DRUG

CCRT+GP

Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21 days for three cycles 4 weeks after radiotherapy.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Adjuvant GP Adjuvant PF

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
* Original clinical staged as any T、N2-3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）
* No evidence of distant metastasis (M0).
* Age 18-65 years old.
* ECOG Performance status less or equal to 1.
* 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.

Exclusion Criteria

* WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
* Age \<18 or \>65 years.
* Treatment with palliative intent.
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
* Pregnancy or lactation.
* History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
* Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No