CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Response to Induction Chemotherapy
Starting soon
Conditions studied: Nasopharyngeal Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07399158
- Run by
- Fujian Cancer Hospital
- People needed
- 223
- Starts
- 2026-02-01
- Expected to finish
- 2030-02-01
- Last updated by the study team
- 2026-02-10
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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