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

NCT07399158 | Not Yet Recruiting DMC

• 1 other identifier: 2026-01-17
• Study Type: observational
• Target: 223
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Local Regional Recurrence-Free Survival

  Baseline, 1 year, 2 years, 3 years

• Overall Survival

  Baseline, 1 year, 2 years, 3 years

• Distant Metastasis-Free Survival

  Baseline, 1 year, 2 years, 3 years

• Complete Response Rate after Radiotherapy

  3 months post-treatment

• 3-4 Grade Acute Toxicity Incidence

  through study completion, an average of 4-6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Yedong Huang, MD. PhD

CONTACT

+86 15959678182; drhuangyd@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Head and Neck Radiation Oncology, Clinical Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): February 1, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share