CROSSROAD: Treatment Regimen Switch - Re-induction Chemotherapy vs. Direct Radiotherapy in LANPC With Inadequate Response to Induction Chemotherapy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasopharyngeal Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 223

Contacts and Locations

• Study Contact: Name: Yedong Huang, MD. PhD; Phone Number: +86 15959678182; Email: drhuangyd@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study will include patients aged 18-70 years with histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II/III) and no distant metastasis. Eligible participants must have completed two cycles of standard induction chemotherapy (e.g., TPF, GP, or TP), and the post-induction treatment evaluation must show stable disease (SD) or disease progression (PD) according to RECIST 1.1 criteria. Patients should have an ECOG Performance Status (PS) of 0-1 and adequate bone marrow, liver, and kidney function to tolerate concurrent chemoradiotherapy.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Re-induction Chemotherapy Group; This group consists of 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. These patients will receive re-induction chemotherapy followed by radiotherapy as part of their treatment regimen.
Direct Radiotherapy Group; This group consists of 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. These patients will receive direct radiotherapy without re-induction chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival	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.	Baseline, 1 year, 2 years, 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local Regional Recurrence-Free Survival	This secondary endpoint will evaluate the 3-year local regional recurrence-free survival (LRRFS) rate between the two treatment groups.	Baseline, 1 year, 2 years, 3 years
Overall Survival	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.	Baseline, 1 year, 2 years, 3 years
Distant Metastasis-Free Survival	This secondary endpoint will evaluate the 3-year distant metastasis-free survival (DMFS) rate.	Baseline, 1 year, 2 years, 3 years
Complete Response Rate after Radiotherapy	This secondary endpoint will assess the rate of complete response (CR) after radiotherapy.	3 months post-treatment
3-4 Grade Acute Toxicity Incidence	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.	through study completion, an average of 4-6 months

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: February 7, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
• Other Study ID Numbers: 2026-01-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No