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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorFujian Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

223 Participants
are grouped into 2 trial groups
Group A: Re-induction Chemotherapy Group
Group B: Direct Radiotherapy Group

Trial outcomes

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.

Time frame
Baseline, 1 year, 2 years, 3 years

Secondary outcomes

1

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.

Time frame
Baseline, 1 year, 2 years, 3 years
2

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.

Time frame
Baseline, 1 year, 2 years, 3 years
3

Distant Metastasis-Free Survival

This secondary endpoint will evaluate the 3-year distant metastasis-free survival (DMFS) rate.

Time frame
Baseline, 1 year, 2 years, 3 years
4

Complete Response Rate after Radiotherapy

This secondary endpoint will assess the rate of complete response (CR) after radiotherapy.

Time frame
3 months post-treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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