Clinical trial NCT04766359: Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma
Official title: Paclitaxel (Albumin-bound) Combined With Radiotherapy Compared With Cisplatin Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma: a Prospective, Parallel-controlled, Multicenter Phase III Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a prospective, parallel controlled, randomized, open, multi-center phase III clinical trial. The trial will enroll 364 patients with nasopharyngeal carcinoma who are staged T1-2N0-1M0 (except T1N0M0) (UICC 8th edition) . This experiment was participated by multiple centers of Nanjing Gulou Hospital, Jiangsu Provincial People's Hospital, Jiangsu Cancer Hospital, Nanjing Military Region General Hospital, Jiangsu Provincial Hospital of Traditional Chinese Medicine, and Zhongda Hospital. Each center competes for admission of cases.

The subjects will be randomly assigned (using the random number table method according to the order of entry) to the experimental group to receive albumin-bound paclitaxel combined with IMRT concurrent radiotherapy, or the control group to receive cisplatin combined with IMRT concurrent radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma confirmed by pathology;
* The staging is T1-2N0-1M0 (except T1N0M0) (UICC 8th edition);
* Initial treatment patients who have not received anti-tumor therapy;
* No history of other malignant tumors;
* Male or female, aged 18 to 70 years old;
* Liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min;
* Neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL;
* No serious heart, lung, liver, kidney and other important organ dysfunction;
* Karnofsky score ≥70 points;
* Sign the informed consent form;
* Able to follow research protocols and follow-up procedures.

Exclusion Criteria:

* Anti-tumor treatment has been performed, including chemotherapy, radiotherapy, and surgery;
* Find distant metastases before treatment;
* Women who are pregnant or breastfeeding;
* Disagree to sign the informed consent form;
* Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons;
* Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research);
* Known to be allergic to possible chemotherapy drugs;
* Patients with other malignant tumors;
* Accompanied by severe uncontrollable infections or medical diseases, including autoimmune diseases;
* Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, cannot tolerate radiotherapy and chemotherapy;
* Laboratory examination: total bilirubin\>upper limit of normal (ULN); AST and/or ALT\>1.5 times ULN and accompanied by alkaline phosphatase\>2.5 times ULN;
* Any uncertain factors that affect patient safety or compliance.

Primary outcomes:
measure: Objective response rate
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: