Clinical trial NCT06228079: Adjuvant Vs Surgery Only in Early-stage Recurrent NPC
Official title: Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage 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: 2024-01-29
Enrollment: 176
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: Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Detailed description: This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial.

Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.

Eligibility criteria: Inclusion Criteria:

1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
2. Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery ≤5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
3. Cervical lymph node metastasis can be controlled locally
4. Age 18 to 75 years;
5. Without distant metastasis;
6. Informed consent forms signed;
7. ≥6months from the accomplishment of radiation to recurrence
8. previously radiotherapy for only 1 course;
9. ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
10. Sufficient organ function;
11. Undergone endoscopic surgery with negative pathological margin;

Exclusion Criteria:

1. Participation in other interventional clinical trials;
2. Uncontrolled illnesses which will interfere with the ability to undergo 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);
4. Any contradiction to immune and chemotherapy;
5. With serious autoimmune disease;
6. Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage\>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
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 are not suitable for enrollment

Primary outcomes:
measure: DFS
timeFrame: From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: OS
timeFrame: From randomization to death of any cause,assessed up to 60 months
measure: LRFS
timeFrame: From randomization to local recurrence or death,assessed up to 24 months
measure: DMFS
timeFrame: From randomization to distant metastasis or death, assessed up to 24 months
measure: 1-and 2-year DFS rate
timeFrame: end of 1st year, end of 2nd year
measure: 1-and 2-year OS rate
timeFrame: end of 1st year, end of 2nd 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:
affiliation: Eye& ENT Hospital, Fudan University
name: Hongmeng Yu
role: PRINCIPAL_INVESTIGATOR
References: