Esophageal Squamous Cell CarcinomaNCT05775419
Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
A study testing Consolidation chemotherapy (4 courses) and Concurrent chemotherapy (2 courses) in people with Esophageal Squamous Cell Carcinoma and Chemotherapy Effect, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug
- What is being tested?
- Consolidation chemotherapy (4 courses) and Concurrent chemotherapy (2 courses)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,216 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 30 Jun 2028
- 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
- Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
- Esophageal squamous cell carcinoma proved by histopathology;
- Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
- According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
- ECOG 0-1; life expectancy > 6 months;
- No chemotherapy was used before selection;
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- No history of radiotherapy;
- No surgical treatment;
- No serious allergic history;
- Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;
Who cannot join
- History of malignant tumors in other parts;
- Duplicate carcinoma of the esophagus;
- Pregnant or lactating patients;
- Fertility but not using contraceptive measures;
- Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
- During the active period of infectious diseases;
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- Participate in other clinical trials at present or within four weeks before enrollment;
- Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
- After esophageal stent placement;
- Cases with perforation tendency;
- Have a history of organ transplantation.
- Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
- Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
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 First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Xiaolin Ge, PhD, 13951818797, doctorsxl@163.com
About this study
Official title: A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy
This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.
Read the detailed description
Test grouping:
Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group;
Specific chemotherapy regimens:
Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.
Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life
- Being tested
- Consolidation chemotherapy (4 courses), Concurrent chemotherapy (2 courses)
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consolidation chemotherapy (4 courses)Combination product
Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen;
Concurrent chemotherapy (2 courses)Combination product
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles;
| Study group | Role | What they receive |
|---|---|---|
| Group A: radical chemoradiotherapy group; | Sham comparator | Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation. Receives: Combination Product: Concurrent chemotherapy (2 courses) |
| Group B: radical chemoradiotherapy combined with consolidation chemotherapy group | Experimental | Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation. Receives: Combination Product: Consolidation chemotherapy (4 courses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-years overall survival (OS)
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
Measured: up to 3 years
5-years overall survival (OS)
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
Measured: up to 5 years
Secondary outcomes (3)
3-year progression-free survival (PFS)
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
Measured: up to 3 years
Objective response rate (ORR) Objective response rate (ORR)
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Measured: through study completion, an average of 36 month
5-year progression-free survival (PFS)
The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start30 Jun 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- 1,216 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaolin GE, MM, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775419
- Sponsor's protocol ID
- GXL-003
- Status last verified
- Mar 2023
- First submitted
- 7 Sep 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy
- ClinicalTrials.gov ID
- NCT05775419
- Acronym / sponsor ID
- GXL-003
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,216 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 20 Mar 2023 (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.
This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.
Detailed description
Test grouping:
Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group;
Specific chemotherapy regimens:
Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.
Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: radical chemoradiotherapy group; | Sham comparator | Combination Product: Concurrent chemotherapy (2 courses)Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation. |
| Group B: radical chemoradiotherapy combined with consolidation chemotherapy group | Experimental | Combination Product: Consolidation chemotherapy (4 courses)Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
- Esophageal squamous cell carcinoma proved by histopathology;
- Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
- According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
- ECOG 0-1; life expectancy > 6 months;
Key exclusion criteria (13 listed)
- History of malignant tumors in other parts;
- Duplicate carcinoma of the esophagus;
- Pregnant or lactating patients;
- Fertility but not using contraceptive measures;
- Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
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 |
|---|---|---|
| Consolidation chemotherapy (4 courses)Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen; | Combination product | Group B: radical chemoradiotherapy combined with consolidation chemotherapy group |
| Concurrent chemotherapy (2 courses)Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; | Combination product | Group A: radical chemoradiotherapy group; |
Primary outcome
3-years overall survival (OS)
Time frame: up to 3 years
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
5-years overall survival (OS)
Time frame: up to 5 years
Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.
3 secondary outcomes
3-year progression-free survival (PFS)
Time frame: up to 3 years
Objective response rate (ORR) Objective response rate (ORR)
Time frame: through study completion, an average of 36 month
5-year progression-free survival (PFS)
Time frame: up to 5 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 20 Mar 2023.
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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.
Xiaolin GE, MM study director
The First Affiliated Hospital with Nanjing Medical 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 Consolidation chemotherapy (4 courses) and Concurrent chemotherapy (2 courses) in people with Esophageal Squamous Cell Carcinoma and Chemotherapy Effect, run by The First Affiliated Hospital with Nanjing Medical University 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 10 inclusion and 13 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 20 Mar 2023. 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. Some participants in this study may receive a placebo. 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 Xiaolin GE, MM (13951818797, doctorsxl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-years overall survival (OS) (time frame: up to 3 years). The study lists 2 primary outcomes in all. 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 20 Mar 2023.