Low-dose Radiotherapy and Neoadjuvant Chemotherapy Sequential Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

NCT05503914 | Unknown

• 1 other identifier: Ahead-NC-202208
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Nasopharyngeal carcinoma#NPC#is common malignant tumor in China. The incidence of NPC in most parts of the world and the country is less than 1/10 million, but the incidence rate in China's Guangdong, Guangxi, Fujian and other southern provinces is as high as 33/10 million. Generally, there are more men than women, with a ratio of 2 \~ 3:1. In high incidence area, nasopharyngeal carcinoma has great harm to middle-aged and young people, and incidence rate and mortality rate increase significantly after 30 years old. 50\~60 years old is the highest peak. More than 70% of patients were in advanced stage at the first diagnosis. At present, the main treatment for locally advanced nasopharyngeal carcinoma is platinum based neoadjuvant chemotherapy combined with concurrent chemoradiotherapy. However, recurrence and distant metastasis after standard treatment are the main causes of failure. About 40% of patients with locally advanced nasopharyngeal carcinoma have recurrence and distant metastasis after receiving standard treatment. Therefore, the investigators intend to further explore the improvement of local control and survival rate of locally advanced nasopharyngeal carcinoma.

Conditions

Locally Advanced Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• The objective remission rate

  The main indicator is objective remission rate (ORR=CR+PR)

  assessed up to 1 month

Secondary Outcomes (1)

• Adverse events and reactions

  assessed up to 1 month

Study Arms (2)

low-dose radiotherapy group

EXPERIMENTAL

Neoadjuvant chemotherapy combined with low-dose radiotherapy sequential concurrent chemoradiotherapy

Radiation: low-dose radiotherapy

control group

NO INTERVENTION

Neoadjuvant chemotherapy sequential concurrent chemoradiotherapy

Interventions

low-dose radiotherapy RADIATION

On the first and second days of induction chemotherapy, local tumor were irradiated with 0.5Gy bid for 4 times.

low-dose radiotherapy group

Eligibility Criteria

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

You may qualify if:

• \. Voluntarily participate and sign the informed consent form of the study in writing 2. Age 18-70 years old, regardless of gender 3. Pathological biopsy confirmed nasopharyngeal squamous cell carcinoma 4. Initial treatment 5. There are lesions that can be measured according to RECIST standard 6. KPS score ≥ 80 7. Estimated survival ≥ 6 months 8. The urine pregnancy test was negative (female), and contraceptive measures were taken from the test period to 3 months after the end of the test 9. Sufficient hematopoietic function: WBC ≥ 4 × 109/L#Hb≥100g/ L#PLT≥100 × 109/L 10. Liver function: ALAT / ASAT \< 1.5 times of ULN, bilirubin \< 1.5 × ULN 11. Renal function: serum creatinine \< 1.5 × ULN 12. No distant metastasis 13.T3-T4 (AJCC / UICC 8th Edition) nasopharyngeal carcinoma 14. According to the judgment of the researcher, the patient is considered to be able to comply with the protocol.

You may not qualify if:

• Those who have received epidermal growth factor targeted therapy
• The primary focus has received immunotherapy
• Other malignant tumors (except non melanoma skin cancer or cervical carcinoma in situ)
• Subjects who have received other drug trials in recent 1 month
• Have a serious history of allergy or special constitution
• A history of severe lung or heart disease or serious complications, such as uncontrollable hypertension and heart failure.
• Drug or alcohol addicts
• Having personality or mental illness, no civil capacity or limited civil capacity
• Active systemic infection
• At the same time, they received chronic systemic immunotherapy or hormone therapy other than this study. -

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Low-dose Radiotherapy and Neoadjuvant Chemotherapy Sequential Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

Sichuan, Sichuan, China

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• feng mei

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

feng mei

CONTACT

13076000700; Freda_fm@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: August 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 17, 2022

Record last verified: 2022-08

Locations

CN (1)