Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma

NCT04766359 | Unknown Phase 3

• 1 other identifier: 2020-236-02
• Study Type: interventional
• Target: 364
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Nasopharyngeal + neck MRI and nasopharyngoscopy: the nasopharyngeal mass disappeared; the nasopharyngeal mucosa was smooth and no lesions were seen on the nasopharyngoscope. The tumor is clinically considered to have completely subsided. Neck MRI showed complete regression of cervical lymph nodes, or combined with clinical findings that the lymph node lesions completely resolved.

  1month

Study Arms (2)

Albumin-Bound paclitaxel combined with radiotherapy

EXPERIMENTAL

Albumin paclitaxel (100mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete.

Drug: Albumin-Bound Paclitaxel

Cisplatin combined with radiotherapy

EXPERIMENTAL

Cisplatin (40mg/m2), D1 intravenous drip, start the first week of radiotherapy, use it continuously for 4-6 weeks. Radiotherapy: The total dose is 66-70Gy, divided into 33-35 times to complete.

Drug: Albumin-Bound Paclitaxel

Interventions

Albumin-Bound Paclitaxel DRUG

Compare the effectiveness and safety of paclitaxel (albumin-bound) combined with radiotherapy and cisplatin combined with radiotherapy in the treatment of early nasopharyngeal carcinoma.

Also known as: Cisplatin, Radiotherapy

Albumin-Bound paclitaxel combined with radiotherapy; Cisplatin combined with radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Albumin-Bound Paclitaxel; Cisplatin; Radiotherapy

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of medicine

Study Record Dates

• First Submitted: February 14, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: February 23, 2021

Record last verified: 2021-02