Esophageal NeoplasmsPhase 4NCT02721550
A Trial of CMNa Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced ESCC
A Phase 4 study testing Sodium Glycididazole in people with Esophageal Neoplasms, run by Shandong Cancer Hospital and Institute at 9 sites in China.
Trial summary
This is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with CMNa combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Sodium Glycididazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 9 sitesChina
- Study dates
- 1 Aug 2016to 30 Jun 2018
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent prior to study entry
- Patients with ESCC in thoracic segment which is resectable（T2-3，N0-1，M0） confirmed by imaging and pathology or cytology;
- Patients have tumor lesions which can be objectively measured ,the length of tumor:≤8cm, the width of tumor:≤5cm;If the tumor cross the GEJ and violate the proximal stomach, the tumor must include esophagus and GEJ. The tumor is less than 2cm of the stomach
- Not infringe bronchial wall; no esophagus-tracheal fistula.
- normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/mm3,hemoglobin≥9g/dl
- normal hepatic funcion:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN
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- normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min
- normal cardiac function
- ECOG PS of 0 or 1
- Expected lifetime≥3 months
- Subjects tumor tissue available for the relevant biomarker detection
Who cannot join
- Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study.
- Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)
- Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan
- Patients who have other malignant lesions, except curable skin cancer (non- melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years
- Primary lesions were multifocal
- Patients with distant metastasis. A small amount of stomach tumor violate GEJ or the distal esophageal.
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- Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation
- received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles).
- Cervical esophageal cancer confirmed by iconography
- Not esophageal squamous carcinoma confirmed by pathology or cytology
- History of active hepatitis
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Qianfoshan Hospital of Shandong
Jinan, Shandong, 250117
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Jining NO.1 People's Hospital
Jining, Shandong, 250117
Liaocheng People Hospital
Liaocheng, Shandong
Qingdao Center Medical Group
Qingdao, Shandong, 250117
Rizhao City People 's Hospital
Rizhao, Shandong
Fei Cheng People's Hospital
Tai’an, Shandong, 250117
An Qiu People's Hospital
Weifang, Shandong, 250117
The Fourth People's Hospitalof Zibo
Zibo, Shandong, 250117
About this study
Official title: A Perspective Trial of Sodium Glycididazole Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
This is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with CMNa combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (pathologic Complete Response) will be done as defined in the protocol.
Read the detailed description
The primary end ponit of this study is pathological complete response.And the primary hypothesis is the CMNa will improve patholofical response rate and thus improve OS、DFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 40 cases.
- Conditions
- Esophageal Neoplasms
- Being tested
- Sodium Glycididazole
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium GlycididazoleDrug
800mg/m2，dissolved in 100ml physiological saline(Now with chef),ivgtt,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy, total 4 weeks course.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Glycididazole | Experimental | Sodium Glycididazole：800mg/m2，finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-4 Cisplatin:20 mg/m²,d1,week 1-4 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle.
OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T40Gy/20f,week 1-4 Receives: Drug: Sodium Glycididazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic Complete Response
TRG-cited from Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, Roussel A, Jacob JH, Segol P, Samama G, Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Cancer, 73, 2680-2686, 1994.
Measured: 1 months
Secondary outcomes (2)
Overall Survival
Measured: 36 months
Disease-Free Survival
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study start1 Aug 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: The number of enrollment cases is too small.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinming Yu, Shandong Cancer Hospital and Institute
- Investigators
- Jinming Yu, Ph.D, M.D, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721550
- Sponsor's protocol ID
- CMNAER1
- Status last verified
- Oct 2019
- First submitted
- 9 Mar 2016
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective Trial of Sodium Glycididazole Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
- ClinicalTrials.gov ID
- NCT02721550
- Acronym / sponsor ID
- CMNAER1
- Conditions
- Esophageal Neoplasms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The number of enrollment cases is too small.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 29 Mar 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.
This is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with CMNa combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (pathologic Complete Response) will be done as defined in the protocol.
Detailed description
The primary end ponit of this study is pathological complete response.And the primary hypothesis is the CMNa will improve patholofical response rate and thus improve OS、DFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 40 cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Glycididazole | Experimental | Drug: Sodium GlycididazoleSodium Glycididazole：800mg/m2，finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-4 Cisplatin:20 mg/m²,d1,week 1-4 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle. OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T40Gy/20f,week 1-4 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed written informed consent prior to study entry
- Patients with ESCC in thoracic segment which is resectable（T2-3，N0-1，M0） confirmed by imaging and pathology or cytology;
- Patients have tumor lesions which can be objectively measured ,the length of tumor:≤8cm, the width of tumor:≤5cm;If the tumor cross the GEJ and violate the proximal stomach, the tumor must include esophagus and GEJ. The tumor is less than 2cm of the stomach
- Not infringe bronchial wall; no esophagus-tracheal fistula.
- normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/mm3,hemoglobin≥9g/dl
Key exclusion criteria (11 listed)
- Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study.
- Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)
- Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan
- Patients who have other malignant lesions, except curable skin cancer (non- melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years
- Primary lesions were multifocal
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 |
|---|---|---|
| Sodium Glycididazole800mg/m2，dissolved in 100ml physiological saline(Now with chef),ivgtt,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy, total 4 weeks course. | Drug | Sodium Glycididazole |
Primary outcome
pathologic Complete Response
Time frame: 1 months
TRG-cited from Mandard AM, Dalibard F, Mandard JC, Marnay J, Henry-Amar M, Petiot JF, Roussel A, Jacob JH, Segol P, Samama G, Pathologic assessment of tumor regression after preoperative chemoradiotherapy of esophageal carcinoma. Cancer, 73, 2680-2686, 1994.
2 secondary outcomes
Overall Survival
Time frame: 36 months
Disease-Free Survival
Time frame: 36 months
Results and safety
The study was stopped early (reason given: The number of enrollment cases is too small.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- 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.
Jinming Yu, Ph.D, M.D principal investigator
Shandong Cancer Hospital and Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Glycididazole in people with Esophageal Neoplasms, run by Shandong Cancer Hospital and Institute at 9 sites 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 11 inclusion and 11 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: stopped early, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: The number of enrollment cases is too small.). Results are not available in the source record.
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?
pathologic Complete Response (time frame: 1 months). 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 11 Oct 2019.