Esophageal Squamous Cell CarcinomaPhase 1NCT02964455
Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 1 study testing Docetaxel, Nedaplatin and chest radiation in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Docetaxel, Nedaplatin and chest radiation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to May 2020
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed esophageal squamous cell carcinoma
- Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
- Eastern Cooperative Oncology Group (ECOG) performance status 1-2
- Estimated life expectancy of at least 12 weeks
- Charlson comorbidity index≤4
- Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
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- Adequate renal function: creatinine grade 0 or 1
- Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
- Weight loss≤15% during 6 months prior to diagnosis
- Forced expiratory volume second≥1L
Who cannot join
- Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
- Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
- Contraindication for chemotherapy or radiotherapy
- Malignant pleural or pericardial effusion
- Women in pregnancy or lactation period
- Women who has the probability of pregnancy without contraception
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- Weight loss≥15% during 3 months prior to diagnosis
- In other clinical trials within 30 days
- Addicted in drugs or alcohol, AIDS patients
- Uncontrollable seizure or psychotic patients without self-control ability
- Severe allergy or idiosyncrasy
- Not suitable for this study judged by researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Phase I Study of Docetaxel and Nedaplatin Twice Weekly in Combination With Chest Radiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Docetaxel, Nedaplatin, chest radiation
- Keywords
- Esophageal squamous cell carcinoma, Chemoradiotherapy, Docetaxel, Nedaplatin, Twice weekly
- 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.
DocetaxelDrug
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
NedaplatinDrug
5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
chest radiationRadiation
continuous chest radiation at 64 Gy/32f
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + Nedaplatin + Radiotherapy | Experimental | Docetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation. Receives: Drug: Docetaxel; Drug: Nedaplatin; Radiation: chest radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicity
Measured: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Maximum tolerated dose
Measured: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Secondary outcomes (3)
Occurrence and severity of adverse events
Measured: From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Clinical response rate
Measured: 8 weeks after end of combination treatment
Dynamic plasma concentration of docetaxel and nedaplatin
Measured: From start of week 1 to the end of combination treatment (6.5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019
- Study completionMay 2020
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 Sun Yat-sen 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Liu, Sun Yat-sen University
- Investigators
- Hui Liu, Prof., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964455
- Sponsor's protocol ID
- GASTO201610003
- Status last verified
- May 2020
- First submitted
- 13 Nov 2016
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Phase I Study of Docetaxel and Nedaplatin Twice Weekly in Combination With Chest Radiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02964455
- Acronym / sponsor ID
- GASTO201610003
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal squamous cell carcinoma, Chemoradiotherapy, Docetaxel, Nedaplatin, Twice weekly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 16 Nov 2016 (estimated)
- 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 phase I study is to determine the maximum tolerated dose and dose limiting toxicity of docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + Nedaplatin + Radiotherapy | Experimental | Drug: Docetaxel, Drug: Nedaplatin, Radiation: chest radiationDocetaxel and nedaplatin 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed esophageal squamous cell carcinoma
- Inoperable stage II-III (AJCC/UICC; seventh edition), confirmed by contrast- enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
- Eastern Cooperative Oncology Group (ECOG) performance status 1-2
- Estimated life expectancy of at least 12 weeks
- Charlson comorbidity index≤4
Key exclusion criteria (12 listed)
- Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
- Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
- Contraindication for chemotherapy or radiotherapy
- Malignant pleural or pericardial effusion
- Women in pregnancy or lactation period
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 |
|---|---|---|
| Docetaxel5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation | Drug | Docetaxel + Nedaplatin + Radiotherapy |
| Nedaplatin5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation | Drug | Docetaxel + Nedaplatin + Radiotherapy |
| chest radiationcontinuous chest radiation at 64 Gy/32f | Radiation | Docetaxel + Nedaplatin + Radiotherapy |
Primary outcome
Occurrence of dose limiting toxicity
Time frame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Maximum tolerated dose
Time frame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)
3 secondary outcomes
Occurrence and severity of adverse events
Time frame: From start of week 1 to 6 weeks after end of combination treatment (combination treatment = 6.5 weeks)
Clinical response rate
Time frame: 8 weeks after end of combination treatment
Dynamic plasma concentration of docetaxel and nedaplatin
Time frame: From start of week 1 to the end of combination treatment (6.5 weeks)
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 15 May 2020.
- 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.
Hui Liu, Prof. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel, Nedaplatin and chest radiation in people with Esophageal Squamous Cell Carcinoma, run by Sun Yat-sen 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 12 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 15 May 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Occurrence of dose limiting toxicity (time frame: From start of week 1 to 2 weeks after end of combination treatment (combination treatment = 6.5 weeks)). 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 15 May 2020.