Nasopharyngeal CarcinomaNCT06529562
Surgery Plus Reduced Target Chemoradiotherapy vs Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma.
A study testing Surgery combined with Target-reduction intensity-modulated radiotherapy and Surgery combined with Dose-reduction intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Ming-Yuan Chen at 1 site in China.
Trial summary
The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery… 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?
- Surgery combined with Target-reduction intensity-modulated radiotherapy and Surgery combined with Dose-reduction intensity-modulated radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Nov 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Performance Status Score 0-1 points.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
- Patients with primary nasopharyngeal lesions evaluated as surgically resectable, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus) and tumor diameter ≤1.5cm. Resectable retropharyngeal lymph nodes were defined as; The diameter was ≤ 1.5cm, the tissue space was intact, and there was no obvious extranodal invasion; The resectable cervical lymph nodes were defined as ≤ 3cm in diameter, located above the lower edge of the cricoid cartilage, with moderate mobility and no obvious extranodal invasion. Clinical stage: T1-3N1-2M0, T2-3N0M0 (Stage II-III) according to AJCC 8th staging edition.
- Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
Who cannot join
- Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
- Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy or chemotherapy.
- Retropharyngeal lymph node diameter>1.5cm, or extranodal invasion, such as invasion of internal carotid artery, muscle, or extensive extracapsular dissemination.
- Cervical lymph node diameter>3cm, or in the area below the lower margin of the cricoid cartilage, or with extranodal invasion, such as invasion of the internal carotid artery, skin, muscle, mediastinal structure, prevertebral fascia or cervical spine, or extensive extra-capsular spread, subcutaneous metastasis, etc.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
- During pregnancy or lactation.
- Other patients that the chief physician considered as illegal for this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
Ming-Yuan Chen, +8613903052650, chmingy@email.sysu.edu.cn
About this study
Official title: Surgery Plus Reduced Target Chemoradiotherapy Versus Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma : a Prospective, Multicenter, Radomized Control Trial
The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .
Read the detailed description
Currently, the treatment of newly diagnosed non-metastatic nasopharyngeal carcinoma with intensity modulated radiotherapy as the core and chemotherapy with platinum-containing drugs has achieved good therapeutic outcomes. However, the toxicity and side effects caused by local radiotherapy greatly affect the quality of life of patients with nasopharyngeal carcinoma during treatment. In order to find a more "high-efficiency and low-toxicity" nasopharyngeal cancer treatment mode, combined with minimally invasive surgery for radical tumor treatment and radiotherapy and chemotherapy to eliminate potential micro-metastatic lesions,, Our team has previously carried out "prospective clinical trial of newly diagnosed operable nasopharyngeal carcinoma surgery combined with reduced target chemoradiotherapy versus conventional chemoradiotherapy", It has been prelim natively confirmed that gross tumor volume(GTV) and clinical tumor volume (CTV1) high-risk infiltrating area need not be recharacterized after the combined nasopharyngeal or non-combined retropharyngeal surgery and radical resection of cervical lesions. Only low risk infiltrating area (CTV2) was delineated and preventive irradiation of 54 Gy/33 times /45 days was administered, combined with induction or concurrent chemotherapy. Preliminary study results showed that it could further reduce the local recurrence of tumors and the overall curative effect while reducing the toxic side effects of treatment and achieve the therapeutic effect of increased efficacy and reduced toxicity.
Although compared to the conventional radiotherapy dose of 70Gy, postoperative reduced target radiotherapy has achieved a significant reduction in radiotherapy dose while ensuring tumor control, However, we are concerned that nearly 40% of patients still have ≥ grade 3 dry mouth, mucosal ulcer, mouth difficulty and dysphagia during or after treatment. Therefore, for newly diagnosed patients with surgically resectable nasopharyngeal carcinoma, we plan to conduct a prospective clinical trial comparing the survival prognosis and toxic side effects of newly diagnosed surgery combined with reduced dose radiotherapy compared with conventional reduced target radiotherapy combined with concurrent chemotherapy. To explore whether this treatment model can bring comparable survival benefits, lower toxic side effects and shorter treatment cycles for patients.
According to our team's previous research results and literature data, we designed the following scheme: patients with operable nasopharyngeal carcinoma were assigned to the control group and the experimental group. Control group: nasopharyngeal combined with or without combined retropharyngeal and neck lesions radical surgery, postoperative routine target reduction chemoradiotherapy at the same period. Experimental group: Patients underwent radical surgery with or without nasopharynx combined with retropharyngeal and cervical lesions, followed by concurrent low-dose radiotherapy and chemotherapy.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Surgery combined with Target-reduction intensity-modulated radiotherapy, Surgery combined with Dose-reduction intensity-modulated radiotherapy
- Keywords
- Surgery, Target-Reduction Chemoradiotherapy, Dose-Reduction Chemoradiotherapy, Locally Resectable Nasopharyngeal Carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery combined with Target-reduction intensity-modulated radiotherapyRadiation
Also called Target-reduction intensity-modulated radiotherapy
in control arm
Surgery combined with Dose-reduction intensity-modulated radiotherapyRadiation
Also called Dose-reduction intensity-modulated radiotherapy
in experimental arm
| Study group | Role | What they receive |
|---|---|---|
| surgery plus target reduction Chemoradiotherapy | Active comparator | Surgery:
Endoscopic Nasopharyngectomy:Radical Reaction of the Primary Lesion Using Nasal Endoscopy.
Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy.
Neck lymph node dissection Selection of region where the possitive lymph nodes are located.
Intensity modulated radiotherapy with GTV and CTV1 Reduction:
CTV2:50.00Gy/25Fr/2.00Gy. Chemotherapy: cisplatin-based regimens. Receives: Radiation: Surgery combined with Target-reduction intensity-modulated radiotherapy |
| surgery plus dose reduction Chemoradiotherapy | Experimental | Surgery:
Endoscopic Nasopharyngectomy: Radical Reaction of the Primary Lesion Using Nasal Endoscopy.
Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy.
Neck lymph node dissection Selection of region where the possitive lymph nodes are located.
Intensity modulated radiotherapy with CTV1 and CTV2 dose Reduction:
CTV1：48.00-50.00Gy/20Fr/2.40-2.50Gy； CTV2：40.00Gy/20Fr/2.00Gy. Chemotherapy: cisplatin-based regimens. Receives: Radiation: Surgery combined with Dose-reduction intensity-modulated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional Recurrence-Free Survival Time (LRRFS)
The time interval between randomization and locoregional recurrence, or censored at the date of the last follow-up.
Measured: 3 years
Secondary outcomes (6)
Overall survival (OS)
The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.
Measured: 3 years
Incidence of Treatment-Related Adverse Events
The proportion of patients with treatment related adverse events according to NCI-CTCAE 5.0 and RTOG criteria.
Measured: 1 years
Distant Metastasis-Free Survival (DMFS)
The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or censored at the date of the last follow-up.
Measured: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment and follow up.
Measured: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H\&N35) before treatment, during treatment, after treatment and follow up.
Measured: 3 years
Progression-Free Survival (PFS)
The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Nov 2022
- Primary completion1 Nov 2032 (estimated)
- Study completion1 Nov 2032 (estimated)
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
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Fifth Affiliated Hospital of Guangzhou Medical University, Huazhong University of Science and Technology Union Shenzhen Hospital, The First Affiliated Hospital of University of South China, People's Hospital of Guangxi Zhuang Autonomous Region, Nanchang City First Hospital
- Responsible party
- Sponsor-investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD,PhD, Principal investigator, SUN yet-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529562
- Sponsor's protocol ID
- SYSUCC-CMY-20240221
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery Plus Reduced Target Chemoradiotherapy Versus Surgery Plus Reduced Dose Chemoradiotherapy for Newly Diagnosed Operable Nasopharyngeal Carcinoma : a Prospective, Multicenter, Radomized Control Trial
- ClinicalTrials.gov ID
- NCT06529562
- Acronym / sponsor ID
- SYSUCC-CMY-20240221
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Surgery, Target-Reduction Chemoradiotherapy, Dose-Reduction Chemoradiotherapy, Locally Resectable Nasopharyngeal Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Collaborators
- Fifth Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Fifth Affiliated Hospital of Guangzhou Medical University, Huazhong University of Science and Technology Union Shenzhen Hospital, The First Affiliated Hospital of University of South China, People's Hospital of Guangxi Zhuang Autonomous Region, Nanchang City First Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 31 Jul 2024 (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.
The goal of this clinical trial is to compare surgery plus reduced target chemoradiotherapy with surgery plus reduced dose chemoradiotherapy in newly diagnosed operable Nasopharyngeal Carcinoma.The main questions it aims to answer are:whether endoscopic surgery combined with reduced dose chemoradiotherapy vs surgery plus target reduction chemoradiotherapy can bring substantial survival benefits, lower toxicity, and shorter treatment cycle for patients with operable nasopharyngeal carcinoma .
Detailed description
Currently, the treatment of newly diagnosed non-metastatic nasopharyngeal carcinoma with intensity modulated radiotherapy as the core and chemotherapy with platinum-containing drugs has achieved good therapeutic outcomes. However, the toxicity and side effects caused by local radiotherapy greatly affect the quality of life of patients with nasopharyngeal carcinoma during treatment. In order to find a more "high-efficiency and low-toxicity" nasopharyngeal cancer treatment mode, combined with minimally invasive surgery for radical tumor treatment and radiotherapy and chemotherapy to eliminate potential micro-metastatic lesions,, Our team has previously carried out "prospective clinical trial of newly diagnosed operable nasopharyngeal carcinoma surgery combined with reduced target chemoradiotherapy versus conventional chemoradiotherapy", It has been prelim natively confirmed that gross tumor volume(GTV) and clinical tumor volume (CTV1) high-risk infiltrating area need not be recharacterized after the combined nasopharyngeal or non-combined retropharyngeal surgery and radical resection of cervical lesions. Only low risk infiltrating area (CTV2) was delineated and preventive irradiation of 54 Gy/33 times /45 days was administered, combined with induction or concurrent chemotherapy. Preliminary study results showed that it could further reduce the local recurrence of tumors and the overall curative effect while reducing the toxic side effects of treatment and achieve the therapeutic effect of increased efficacy and reduced toxicity.
Although compared to the conventional radiotherapy dose of 70Gy, postoperative reduced target radiotherapy has achieved a significant reduction in radiotherapy dose while ensuring tumor control, However, we are concerned that nearly 40% of patients still have ≥ grade 3 dry mouth, mucosal ulcer, mouth difficulty and dysphagia during or after treatment. Therefore, for newly diagnosed patients with surgically resectable nasopharyngeal carcinoma, we plan to conduct a prospective clinical trial comparing the survival prognosis and toxic side effects of newly diagnosed surgery combined with reduced dose radiotherapy compared with conventional reduced target radiotherapy combined with concurrent chemotherapy. To explore whether this treatment model can bring comparable survival benefits, lower toxic side effects and shorter treatment cycles for patients.
According to our team's previous research results and literature data, we designed the following scheme: patients with operable nasopharyngeal carcinoma were assigned to the control group and the experimental group. Control group: nasopharyngeal combined with or without combined retropharyngeal and neck lesions radical surgery, postoperative routine target reduction chemoradiotherapy at the same period. Experimental group: Patients underwent radical surgery with or without nasopharynx combined with retropharyngeal and cervical lesions, followed by concurrent low-dose radiotherapy and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery plus target reduction Chemoradiotherapy | Active comparator | Radiation: Surgery combined with Target-reduction intensity-modulated radiotherapySurgery: Endoscopic Nasopharyngectomy:Radical Reaction of the Primary Lesion Using Nasal Endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy. Neck lymph node dissection Selection of region where the possitive lymph nodes are located. Intensity modulated radiotherapy with GTV and CTV1 Reduction: CTV2:50.00Gy/25Fr/2.00Gy. Chemotherapy: cisplatin-based regimens. |
| surgery plus dose reduction Chemoradiotherapy | Experimental | Radiation: Surgery combined with Dose-reduction intensity-modulated radiotherapySurgery: Endoscopic Nasopharyngectomy: Radical Reaction of the Primary Lesion Using Nasal Endoscopy. Retropharyngeal lymphadenectomy: Radical retropharyngeal LNs reaction using nasal endoscopy. Neck lymph node dissection Selection of region where the possitive lymph nodes are located. Intensity modulated radiotherapy with CTV1 and CTV2 dose Reduction: CTV1：48.00-50.00Gy/20Fr/2.40-2.50Gy； CTV2：40.00Gy/20Fr/2.00Gy. Chemotherapy: cisplatin-based regimens. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Performance Status Score 0-1 points.
- Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
- Patients with primary nasopharyngeal lesions evaluated as surgically resectable, including T1 (tumor limited to nasopharynx), T2 (tumor limited to the surface of parapharyngeal space) and T3 (tumor limited to the bottom wall of sphenoid sinus) and tumor diameter ≤1.5cm. Resectable retropharyngeal lymph nodes were defined as; The diameter was ≤ 1.5cm, the tissue space was intact, and there was no obvious extranodal invasion; The resectable cervical lymph nodes were defined as ≤ 3cm in diameter, located above the lower edge of the cricoid cartilage, with moderate mobility and no obvious extranodal invasion. Clinical stage: T1-3N1-2M0, T2-3N0M0 (Stage II-III) according to AJCC 8th staging edition.
- Adequate organ function: WBC ≥ 4×10^9 /L, NEUT ≥ 2×10^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10^9/L, TBIL ≤1.5 ULN (TBIL ≤3 ULN for patients with Gilbert Disease), ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
- Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.
Key exclusion criteria (7 listed)
- Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
- Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy or chemotherapy.
- Retropharyngeal lymph node diameter>1.5cm, or extranodal invasion, such as invasion of internal carotid artery, muscle, or extensive extracapsular dissemination.
- Cervical lymph node diameter>3cm, or in the area below the lower margin of the cricoid cartilage, or with extranodal invasion, such as invasion of the internal carotid artery, skin, muscle, mediastinal structure, prevertebral fascia or cervical spine, or extensive extra-capsular spread, subcutaneous metastasis, etc.
- Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
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 |
|---|---|---|
| Surgery combined with Target-reduction intensity-modulated radiotherapyAlso: Target-reduction intensity-modulated radiotherapyin control arm | Radiation | surgery plus target reduction Chemoradiotherapy |
| Surgery combined with Dose-reduction intensity-modulated radiotherapyAlso: Dose-reduction intensity-modulated radiotherapyin experimental arm | Radiation | surgery plus dose reduction Chemoradiotherapy |
Primary outcome
Locoregional Recurrence-Free Survival Time (LRRFS)
Time frame: 3 years
The time interval between randomization and locoregional recurrence, or censored at the date of the last follow-up.
6 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Incidence of Treatment-Related Adverse Events
Time frame: 1 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time frame: 3 years
Progression-Free Survival (PFS)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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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.
Ming-Yuan Chen, MD,PhD principal investigator
SUN yet-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery combined with Target-reduction intensity-modulated radiotherapy and Surgery combined with Dose-reduction intensity-modulated radiotherapy in people with Nasopharyngeal Carcinoma, run by Ming-Yuan Chen 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yuan Chen, MD,PhD (86-13903052650, chmingy@email.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Locoregional Recurrence-Free Survival Time (LRRFS) (time frame: 3 years). 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 Jul 2024.