Esophageal NeoplasmsPhase 2NCT03254511
Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer
A Phase 2 study testing Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable, Radiotherapy and Chemotherapeutic Combinations in people with Esophageal Neoplasms, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. Sample size is 100 people (50 people in each group). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable, Radiotherapy and Chemotherapeutic Combinations
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- 22 Jul 2016to 30 Dec 2018
- Phase
- Phase 2
- 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
- Definitive diagnoses of esophageal squamous cell carcinoma by pathological evaluation
- Non-metastatic esophageal cancer
- Patient who are candidate for chemo-radiation treatment
- Normal complete blood count
- Normal kidney function test
- Normal liver function test
- Normal fasting blood sugar
Who cannot join
- Previous history of chest wall radiotherapy
- Previous history of chemotherapy
- Past medical history of Hypertension, diabetes mellitus, renal failure and liver failure
- Pathological report of adenocarcinoma or small cell carcinoma, neoplasm of other organs
- Discontent for the study
- Inability to do daily radiotherapy
- Unwillingness to esophagectomy
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province, 917751365
Mohsen Tafaghodi, M.D., 00985138823255, vcresearch@mums.ac.ir
About this study
Official title: The Effect of Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer on the Clinical and Pathologic Response
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention group, patients are going to inject an enoxaparin (40 mg) daily concurrent by chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to control group (only chemo-radiotherapy) and intervention group (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological findings (after esophagectomy) are considered as clinical and pathological response, respectively.
Read the detailed description
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. One hundred patients are going to assign randomly by blocked randomized allocation (1:1) to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with or without enoxaparin (40 mg daily). During radiotherapy and before each course of chemotherapy, all patients are going to visit by physician and complete blood count will be checked. All patients are going to undergo gastrointestinal endoscopy and then esophagectomy, 4-6 months after completion of chemo-radiotherapy.
- Conditions
- Esophageal Neoplasms
- Being tested
- Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable, Radiotherapy, Chemotherapeutic Combinations
- Keywords
- neoadjuvant chemoradiation, pathologic response, low molecular weight heparin
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous InjectableDrug
Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).
RadiotherapyRadiation
Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.
Chemotherapeutic CombinationsDrug
Patients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]).
| Study group | Role | What they receive |
|---|---|---|
| enoxaparin | Experimental | In the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily). Receives: Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable; Radiation: Radiotherapy; Drug: Chemotherapeutic Combinations |
| control | Active comparator | In the control group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) alone. Receives: Radiation: Radiotherapy; Drug: Chemotherapeutic Combinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response
according to endoscopic findings (no lesion, primary lesion or became smaller less than 50%of primary lesion, become smaller more than 50% of primary lesion)
Measured: up to 6 weeks
pathologic response
according to pathologic findings of esophageus specimen (complete Vs incomplete)
Measured: up to 6 weeks
R staging (residual of tumor)
according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)
Measured: up to 6 weeks
Secondary outcomes (1)
heparin induced thrombocytopenia
according to complete blood count
Measured: through study completion, an average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start22 Jul 2016
- Primary completion30 Dec 2017 (estimated)
- Study completion30 Dec 2018 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyed Alireza Javadinia, Mashhad University of Medical Sciences
- Investigators
- Ali Taghizadeh Kermani, M.D., Study chair, Omid Hospital, Mashhad University of Medical Sciences, Mashhad, IranSareh Hosseini, M.D., Study director, Omid Hospital, Mashhad University of Medical Sciences, Mashhad, IranSeyed Alireza Javadinia, M.D., Principal investigator, Omid Hospital, Mashhad University of Medical Sciences, Mashhad, IranArezoo Gholami, M.D., Principal investigator, Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254511
- Sponsor's protocol ID
- 941703
- Other IDs
- IRCT2016070628814N1
- Status last verified
- Aug 2017
- First submitted
- 11 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer on the Clinical and Pathologic Response
- ClinicalTrials.gov ID
- NCT03254511
- Acronym / sponsor ID
- 941703
- Conditions
- Esophageal Neoplasms
- Keywords
- neoadjuvant chemoradiation, pathologic response, low molecular weight heparin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 30 Dec 2017 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 18 Aug 2017 (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 is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. Sample size is 100 people (50 people in each group). In the intervention group, patients are going to inject an enoxaparin (40 mg) daily concurrent by chemo-radiation. Therefore patients with esophageal cancer are going to assign randomly to control group (only chemo-radiotherapy) and intervention group (chemo-radiotherapy+enoxaparin) using 1:1 allocation. Four to 6 weeks after treatment, all patients undergo upper GI endoscopy and then esophagectomy. Endoscopic and pathological findings (after esophagectomy) are considered as clinical and pathological response, respectively.
Detailed description
This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. One hundred patients are going to assign randomly by blocked randomized allocation (1:1) to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with or without enoxaparin (40 mg daily). During radiotherapy and before each course of chemotherapy, all patients are going to visit by physician and complete blood count will be checked. All patients are going to undergo gastrointestinal endoscopy and then esophagectomy, 4-6 months after completion of chemo-radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| enoxaparin | Experimental | Drug: Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable, Radiation: Radiotherapy, Drug: Chemotherapeutic CombinationsIn the enoxaparin group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) with Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable (40 mg daily). |
| control | Active comparator | Radiation: Radiotherapy, Drug: Chemotherapeutic CombinationsIn the control group, patients are going to receive radiotherapy (median treatment dose will be 50.40 Gy in 25 to 32 fractions) with weekly concurrent chemotherapeutic combinations (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]) alone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Definitive diagnoses of esophageal squamous cell carcinoma by pathological evaluation
- Non-metastatic esophageal cancer
- Patient who are candidate for chemo-radiation treatment
- Normal complete blood count
- Normal kidney function test
Key exclusion criteria (7 listed)
- Previous history of chest wall radiotherapy
- Previous history of chemotherapy
- Past medical history of Hypertension, diabetes mellitus, renal failure and liver failure
- Pathological report of adenocarcinoma or small cell carcinoma, neoplasm of other organs
- Discontent for the study
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 |
|---|---|---|
| Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous InjectablePatients are going to receive subcutaneouse Enoxaparin (40 mg daily). | Drug | enoxaparin |
| RadiotherapyPatients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions. | Radiation | control, enoxaparin |
| Chemotherapeutic CombinationsPatients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]). | Drug | control, enoxaparin |
Primary outcome
clinical response
Time frame: up to 6 weeks
according to endoscopic findings (no lesion, primary lesion or became smaller less than 50%of primary lesion, become smaller more than 50% of primary lesion)
pathologic response
Time frame: up to 6 weeks
according to pathologic findings of esophageus specimen (complete Vs incomplete)
R staging (residual of tumor)
Time frame: up to 6 weeks
according to surgeon findings when esophagectomy is done (gross residue, microscopic residue, without residue)
1 secondary outcome
heparin induced thrombocytopenia
Time frame: through study completion, an average of 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Ali Taghizadeh Kermani, M.D. study chair
Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
Sareh Hosseini, M.D. study director
Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
Seyed Alireza Javadinia, M.D. principal investigator
Omid Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable, Radiotherapy and Chemotherapeutic Combinations in people with Esophageal Neoplasms, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 7 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arezoo Gholami, M.D. (00989155252690, gholamia931@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical response (time frame: up to 6 weeks). The study lists 3 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 22 Aug 2017.