Clinical trial NCT06235203: Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
Official title: Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Recurrent Nasopharyngeal Carcinoma
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Shanghai 6th People's Hospital
name: Changhai Hospital
name: Fujian Medical University Union Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Shenzhen Second People's Hospital
First posted: 2024-01-31
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

Detailed description: Eligible patients are randomized into the control group and the experimental group.

Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy.

Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.

Eligibility criteria: Inclusion Criteria:

1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition;
3. Cervical lymph node metastasis can be controlled locally;
4. Aged 18 to 75 years;
5. Informed consent forms signed to participate in the trial;
6. Without distant metastasis;
7. ≥6months from the accomplishment of radical radiation to recurrence
8. previously only 1 course of radiotherapy;
9. Sufficient organ function;
10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy.

Exclusion Criteria:

1. Participate in other interventional clinical trials;
2. Uncontrolled illnesses that interfere with the therapy;
3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ, etc.);
4. Any contradiction to surgery;
5. With serious autoimmune disease;
6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration;
7. Severe allergic reactions to other monoclonal antibodies;
8. History of radioactive particle planting;
9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
10. Female patients who are at pregnancy or lactation;
11. Other situations that the researchers believe not suitable for enrollment

Primary outcomes:
measure: EFS
timeFrame: From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year
Secondary outcomes:
measure: OS
timeFrame: Time interval of randomization and death of any cause, up to 5 years
measure: DFS
timeFrame: From randomization to recurrence, metastasis or death, up to 1 year
measure: LRFS
timeFrame: From randomization to local recurrence or death, up to 1 year
measure: DMFS
timeFrame: From randomization to distant metastasis or death, up to 1 year
measure: pCR
timeFrame: Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery
measure: ORR
timeFrame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
measure: DCR
timeFrame: Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year
measure: DoR
timeFrame: First date of response to the date of progression, up to 5 years
measure: 1-and 2-year PFS rate
timeFrame: one- and two-year
measure: 1-and 2-year OS rate
timeFrame: one- and two-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye& ENT Hospital, Fudan University
state: Shanghai
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
city: Shanghai
country: China
facility: Changhai Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
Study officials:
References: