NCT Number: NCT07399158
This study aims to compare the efficacy of two treatment strategies-re-induction chemotherapy followed by radiotherapy versus direct radiotherapy-in patients with locally advanced nasopharyngeal carcinoma (LANPC) who did not achieve a sufficient response (stable disease or disease progression) after two cycles of induction chemotherapy. The study will enroll patients who have completed two cycles of induction chemotherapy and have not achieved a partial or complete response. Participants will receive one of the two treatment options to evaluate their three-year progression-free survival (PFS) and other clinical outcomes.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Age: 18 to 70 years old.
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III).
Initial treatment with no distant metastasis: Locally advanced nasopharyngeal carcinoma (according to the AJCC/UICC 9th edition staging, stage II-III, i.e., T3-4N0-3M0 or T1-2N2-3M0).
Completion of two cycles of standard induction chemotherapy (such as TPF, GP, TP, etc.).
Post-induction chemotherapy evaluation: Disease stability (SD) or disease progression (PD) after two cycles of induction chemotherapy, as assessed by RECIST 1.1 criteria, based on enhanced MRI of the nasopharynx.
ECOG Performance Status (PS): 0-1.
Bone marrow, liver, and kidney function: Sufficient to tolerate concurrent chemoradiotherapy (specific criteria to be referenced).
Informed consent: Voluntary participation in the study and signing of written informed consent.
Exclusion criteria
History of head and neck tumor radiotherapy or any other malignant cancer history (except for cured non-melanoma skin cancer).
Partial response (PR) or complete response (CR) after induction chemotherapy.
Severe uncontrolled comorbidities, such as unstable angina, congestive heart failure, severe chronic obstructive pulmonary disease (COPD), or uncontrolled diabetes mellitus.
Active infection or severe immunodeficiency diseases.
Pregnant or breastfeeding women.
Any mental or social disorders that may interfere with study evaluation or compliance.
Other conditions deemed by the investigator to be unsuitable for participation in the study.
Time frame: Baseline, 1 year, 2 years, 3 years
The primary endpoint of this study is to compare the 3-year progression-free survival (PFS) rate between the two treatment groups. Disease progression will be assessed using RECIST 1.1 criteria, with imaging exams (such as MRI) used to monitor tumor size and progression.
Time frame: Baseline, 1 year, 2 years, 3 years
This secondary endpoint will evaluate the 3-year local regional recurrence-free survival (LRRFS) rate between the two treatment groups.
Time frame: Baseline, 1 year, 2 years, 3 years
This secondary endpoint will evaluate the 3-year overall survival (OS) rate. The OS rate will be compared between the re-induction chemotherapy followed by radiotherapy group and the direct radiotherapy group.
Time frame: Baseline, 1 year, 2 years, 3 years
This secondary endpoint will evaluate the 3-year distant metastasis-free survival (DMFS) rate.
Time frame: 3 months post-treatment
This secondary endpoint will assess the rate of complete response (CR) after radiotherapy.
Time frame: through study completion, an average of 4-6 months
This secondary endpoint will assess the incidence of grade 3 or 4 acute toxicity, based on the Common Terminology Criteria for Adverse Events (CTCAE) scale. The toxicity will be assessed during the course of the treatment.
Contact information is provided by the study sponsor or research team.
Fujian Cancer Hospital
Other Gov
CROSSROAD: A Prospective Multicenter Observational Study on the Efficacy of Treatment Regimen Switch With Re-induction Chemotherapy Versus Direct Radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Inadequate Response (SD/PD) After Induction Chemotherapy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07667400
Adenocarcinoma, Adenoid Cystic Carcinoma
Bethesda, Maryland, United States
View Trial DetailsNCT07650266
Carcinoma, Head and Neck Neoplasms
Basking Ridge, New Jersey, United States
View Trial DetailsNCT07555860
Carcinoma, Head and Neck Neoplasms
View Trial DetailsNCT07540390
Carcinoma, Head and Neck Neoplasms
Guangzhou, Guangdong, China
View Trial Details