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

NCT05292027 | Completed

• 1 other identifier: Ahead-NC-202201
• Study Type: interventional
• Target: 84
• 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

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Cancinoma ;low dose fractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• The objective remission rate

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

  assessed 3 weeks after the induction treatment

Secondary Outcomes (4)

• Adverse events and reactions were evaluated according to NCI CTCAE version 3.0

  assessed up to 3 month after treatment

• 2-year progression-free survival

  From end of treatment to 2 years

• 2-year overall survival

  From end of treatment to 2 years

• 2-year distant metastasis-free survival

  From end of treatment to 2 years

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, lymph nodes 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
• Age 18-70 years old, regardless of gender
• Pathological biopsy confirmed nasopharyngeal squamous cell carcinoma
• Initial treatment
• There are lesions that can be measured according to RECIST standard
• KPS score ≥ 80
• Estimated survival ≥ 6 months
• 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
• Sufficient hematopoietic function: WBC ≥ 4 × 109/L，Hb≥100g/L，PLT≥100 × 109/L
• Liver function: ALAT / ASAT \< 1.5 times of ULN, bilirubin \< 1.5 × ULN
• Renal function: serum creatinine \< 1.5 × ULN
• No distant metastasis
• Lymph nodes meet one of them:node necrosis, extranodal invasion, or shortest diameter ≥3 cm
• The clinical stage was N2-3 (AJCC / UICC 8th Edition) locally advanced nasopharyngeal carcinoma
• According to the judgment of the researcher, the patient is considered to be able to comply with the protocol.

You may not qualify if:

• There is evidence of distant metastasis
• The primary tumor or lymph node has been treated surgically (except biopsy)
• Patients with primary focus or lymph nodes who have received radiotherapy
• Those who have received epidermal growth factor targeted therapy
• The primary focus has received chemotherapy or 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
• Pregnant or lactating women and women of childbearing age who refuse contraception during the treatment observation period
• 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
• Refusal or inability to sign informed consent to participate in the trial
• Drug or alcohol addicts
• Having personality or mental illness, no civil capacity or limited civil capacity
• Creatinine clearance \< 30ml / min
• Active systemic infection

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

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)

Therapeutics

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: March 12, 2022
• First Posted: March 23, 2022
• Study Start: March 26, 2022
• Primary Completion: November 18, 2022
• Study Completion: December 12, 2024
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)