Nasopharyngeal CarcinomaNCT05292027
Neoadjuvant Chemotherapy and Low-dose Radiotherapy Sequential Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma
A study testing low-dose radiotherapy in people with Nasopharyngeal Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- low-dose radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2022to 12 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
- At the same time, they received chronic systemic immunotherapy or hormone therapy other than this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China
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.
Read the detailed description
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. According to the statistics of the international cancer research center, there were about 129000 new cases of nasopharyngeal carcinoma in 2018.The pathogenesis of NPC is caused by many factors: heredity, environment and virus infection. Among them, EB virus is closely related to the pathogenesis of NPC. 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. Radiotherapy is the main treatment of nasopharyngeal carcinoma. With the application of intensity modulated radiotherapy, the 5-year local control and regional recurrence free survival rate of nasopharyngeal carcinoma have been increased to more than 83%. 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. A large number of clinical studies and meta-analysis show that induction chemotherapy combined with concurrent chemoradiotherapy can significantly improve the progression free survival rate and overall survival rate compared with concurrent chemoradiotherapy alone. Induction chemotherapy can reduce the risk of systemic recurrence and metastasis by controlling the occurrence of tumor. Based on the above research, neoadjuvant chemotherapy for locally advanced nasopharyngeal carcinoma has been written into the national comprehensive cancer network(NCCN) of the United States and the Chinese Clinical Oncology(CSCO) guidelines. In addition, studies have shown that the transverse diameter of retropharyngeal lymph nodes, lymph node zoning, lymph node envelope invasion, edge enhancement, necrosis, fusion and the number of lymph nodes are the main factors of failure after standard treatment. In recent years, a large number of studies are exploring various radiotherapy strategies, such as changing the mode of radiotherapy segmentation and hypersensitivity (HRS), in order to further improve local control and survival. Therefore, the investigators plan to carry out a randomized, controlled phase II prospective clinical study of neoadjuvant chemotherapy combined with low-dose radiotherapy and sequential concurrent radiotherapy and chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma.
Joiner recognized the potential of low-dose fractionated radiotherapy as early as 20 years ago. Namely: high radiosensitivity (HRS), which means that the initial dose can produce radiosensitivity from 0 to 80 cGy. Low-dose fractionated radiation therapy (LDFRT) is a unique radiobiological phenomenon. This phenomenon reports that the effect of induced chemotherapy can be increased by reducing MDR-1 and overcoming the antiapoptotic effect of Bcl-2, resulting in the death of nuclear factors kappa-b29 and p53.This radiation is different from conventional fractionated or large fractionated radiotherapy. Conventional segmentation or high-dose segmentation will not only kill tumor cells, but also make tumor cells resistant to radiation. Studies have shown that low-dose radiotherapy (LDFRT) in the range of 50 - 80 cGy can be used as a chemical sensitizer to enhance the effect of chemotherapy, increase tumor response and improve local control.
At present, clinical studies have reported that in locally advanced Squamous cell carcinoma of head and neck（SCCHN）, the clinical experiment of induction chemotherapy (paclitaxel + carboplatin) combined with LDFRT has achieved preliminary success, and showed that the optimal dose is 50-80cGy 4 times / day. Importantly, it did not increase the toxic and side effects of induction chemotherapy. Subsequently, the results of a long-term SCCHN trial reported that the primary endpoint complete response rate (CR), secondary endpoint overall survival (OS), progression free survival (PFS) and toxicity of LDFRT combined with induction chemotherapy had clinical significance. In breast cancer research, LDFRT can delay tumor progression by deactivating JAK1/STAT3 pathway and inhibit breast cancer cell self-renewal, resulting in a weakening of CD44/CD24. This provides a choice for future treatment strategies to prevent breast cancer metastasis. In addition, LDFRT also has a certain therapeutic effect on recurrent and multiple refractory mantle cell lymphoma (MCL), and shows that low-dose radiotherapy combined with chemotherapy is safe. LDFRT can provide lasting local control by treating the active part of the disease, achieve focal remission, and provide opportunities for patients' subsequent treatment. At present, the role of LDFRT in locally advanced nasopharyngeal carcinoma is still unclear. Whether it can improve the efficacy of neoadjuvant chemotherapy is worth exploring.
In conclusion, neoadjuvant chemotherapy combined with LDFRT provides a new idea for tumor treatment. Low dose fractionated radiotherapy is used to enhance the objective remission rate of induction chemotherapy, make high-risk tumor lesions become the target area, and up regulate the apoptotic proteins bax and bcl-x in the microenvironment to achieve the greatest benefit. Therefore, it is of great clinical value to explore the application of neoadjuvant chemotherapy combined with low-dose radiotherapy (LDFRT) sequential concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma (NPC).
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- low-dose radiotherapy
- Keywords
- Nasopharyngeal Cancinoma ;low dose fractionated radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose radiotherapyRadiation
On the first and second days of induction chemotherapy, lymph nodes were irradiated with 0.5Gy bid for 4 times.
| Study group | Role | What they receive |
|---|---|---|
| low-dose radiotherapy group | Experimental | Neoadjuvant chemotherapy combined with low-dose radiotherapy sequential concurrent chemoradiotherapy Receives: Radiation: low-dose radiotherapy |
| control group | No intervention | Neoadjuvant chemotherapy sequential concurrent chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective remission rate
Efficacy evaluation .The main indicator is objective remission rate (ORR=CR+PR)
Measured: assessed 3 weeks after the induction treatment
Secondary outcomes (4)
Adverse events and reactions were evaluated according to NCI CTCAE version 3.0
Safety evaluation
Measured: assessed up to 3 month after treatment
2-year progression-free survival
2-Year PFS specifically refers to the proportion of patients who remain disease-free for at least two years after starting treatment.
Measured: From end of treatment to 2 years
2-year overall survival
2-Year OS specifically refers to the proportion of patients who remain alive for at least two years after treatment.
Measured: From end of treatment to 2 years
2-year distant metastasis-free survival
2-Year DMFS specifically refers to the proportion of patients who remain distant metastasis-free for at least two years after treatment.
Measured: From end of treatment to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start26 Mar 2022
- Primary completion18 Nov 2022
- Study completion12 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Feng, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292027
- Sponsor's protocol ID
- Ahead-NC-202201
- Status last verified
- Dec 2024
- First submitted
- 12 Mar 2022
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China
- ClinicalTrials.gov ID
- NCT05292027
- Acronym / sponsor ID
- Ahead-NC-202201
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal Cancinoma ;low dose fractionated radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 26 Mar 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 12 Dec 2024 (actual)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. According to the statistics of the international cancer research center, there were about 129000 new cases of nasopharyngeal carcinoma in 2018.The pathogenesis of NPC is caused by many factors: heredity, environment and virus infection. Among them, EB virus is closely related to the pathogenesis of NPC. 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. Radiotherapy is the main treatment of nasopharyngeal carcinoma. With the application of intensity modulated radiotherapy, the 5-year local control and regional recurrence free survival rate of nasopharyngeal carcinoma have been increased to more than 83%. 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. A large number of clinical studies and meta-analysis show that induction chemotherapy combined with concurrent chemoradiotherapy can significantly improve the progression free survival rate and overall survival rate compared with concurrent chemoradiotherapy alone. Induction chemotherapy can reduce the risk of systemic recurrence and metastasis by controlling the occurrence of tumor. Based on the above research, neoadjuvant chemotherapy for locally advanced nasopharyngeal carcinoma has been written into the national comprehensive cancer network(NCCN) of the United States and the Chinese Clinical Oncology(CSCO) guidelines. In addition, studies have shown that the transverse diameter of retropharyngeal lymph nodes, lymph node zoning, lymph node envelope invasion, edge enhancement, necrosis, fusion and the number of lymph nodes are the main factors of failure after standard treatment. In recent years, a large number of studies are exploring various radiotherapy strategies, such as changing the mode of radiotherapy segmentation and hypersensitivity (HRS), in order to further improve local control and survival. Therefore, the investigators plan to carry out a randomized, controlled phase II prospective clinical study of neoadjuvant chemotherapy combined with low-dose radiotherapy and sequential concurrent radiotherapy and chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma.
Joiner recognized the potential of low-dose fractionated radiotherapy as early as 20 years ago. Namely: high radiosensitivity (HRS), which means that the initial dose can produce radiosensitivity from 0 to 80 cGy. Low-dose fractionated radiation therapy (LDFRT) is a unique radiobiological phenomenon. This phenomenon reports that the effect of induced chemotherapy can be increased by reducing MDR-1 and overcoming the antiapoptotic effect of Bcl-2, resulting in the death of nuclear factors kappa-b29 and p53.This radiation is different from conventional fractionated or large fractionated radiotherapy. Conventional segmentation or high-dose segmentation will not only kill tumor cells, but also make tumor cells resistant to radiation. Studies have shown that low-dose radiotherapy (LDFRT) in the range of 50 - 80 cGy can be used as a chemical sensitizer to enhance the effect of chemotherapy, increase tumor response and improve local control.
At present, clinical studies have reported that in locally advanced Squamous cell carcinoma of head and neck（SCCHN）, the clinical experiment of induction chemotherapy (paclitaxel + carboplatin) combined with LDFRT has achieved preliminary success, and showed that the optimal dose is 50-80cGy 4 times / day. Importantly, it did not increase the toxic and side effects of induction chemotherapy. Subsequently, the results of a long-term SCCHN trial reported that the primary endpoint complete response rate (CR), secondary endpoint overall survival (OS), progression free survival (PFS) and toxicity of LDFRT combined with induction chemotherapy had clinical significance. In breast cancer research, LDFRT can delay tumor progression by deactivating JAK1/STAT3 pathway and inhibit breast cancer cell self-renewal, resulting in a weakening of CD44/CD24. This provides a choice for future treatment strategies to prevent breast cancer metastasis. In addition, LDFRT also has a certain therapeutic effect on recurrent and multiple refractory mantle cell lymphoma (MCL), and shows that low-dose radiotherapy combined with chemotherapy is safe. LDFRT can provide lasting local control by treating the active part of the disease, achieve focal remission, and provide opportunities for patients' subsequent treatment. At present, the role of LDFRT in locally advanced nasopharyngeal carcinoma is still unclear. Whether it can improve the efficacy of neoadjuvant chemotherapy is worth exploring.
In conclusion, neoadjuvant chemotherapy combined with LDFRT provides a new idea for tumor treatment. Low dose fractionated radiotherapy is used to enhance the objective remission rate of induction chemotherapy, make high-risk tumor lesions become the target area, and up regulate the apoptotic proteins bax and bcl-x in the microenvironment to achieve the greatest benefit. Therefore, it is of great clinical value to explore the application of neoadjuvant chemotherapy combined with low-dose radiotherapy (LDFRT) sequential concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma (NPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose radiotherapy group | Experimental | Radiation: low-dose radiotherapyNeoadjuvant chemotherapy combined with low-dose radiotherapy sequential concurrent chemoradiotherapy |
| control group | No intervention | –Neoadjuvant chemotherapy sequential concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-dose radiotherapyOn the first and second days of induction chemotherapy, lymph nodes were irradiated with 0.5Gy bid for 4 times. | Radiation | low-dose radiotherapy group |
Primary outcome
The objective remission rate
Time frame: assessed 3 weeks after the induction treatment
Efficacy evaluation .The main indicator is objective remission rate (ORR=CR+PR)
4 secondary outcomes
Adverse events and reactions were evaluated according to NCI CTCAE version 3.0
Time frame: assessed up to 3 month after treatment
2-year progression-free survival
Time frame: From end of treatment to 2 years
2-year overall survival
Time frame: From end of treatment to 2 years
2-year distant metastasis-free survival
Time frame: From end of treatment to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-dose radiotherapy in people with Nasopharyngeal Carcinoma, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The objective remission rate (time frame: assessed 3 weeks after the induction treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.