The effect of addition of enoxaparin to neoadjuvant chemoradiation of esophageal cancer on the clinical and pathologic response and value of post-chemoradiation findings in prediction of complete 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 daily. Therefor 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070628814N1
Registration date:2016-07-17, 1395/04/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-17, 1395/04/27
Registrant information
Name
Arezou Gholami
Name of organization / entity
Department of Oncology, Omid Hospital, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2736
Email address
gholamia931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences and Researcher
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of addition of enoxaparin to neoadjuvant chemoradiation of esophageal cancer on the clinical and pathologic response and value of post-chemoradiation findings in prediction of complete pathologic response
Public title
The effects of enoxaparin in treatment of esophageal cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are definitive diagnoses of esophageal cancer by oncologist and pathological evaluation, non-metastatic esophageal cancer, patient who are candidate for chemo-radiation treatment, pathological report of SCC, normal CBC, normal kidney function test, normal liver function test, normal FBS.
Exclusion criteria are previous history of chest wall radiotherapy, previous history of chemotherapy, past medical history of HTN, DM, 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.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random allocation and blinding was done this way: using a computerized random number table, patients are going to assign to intervention or control groups. Patient are going to be blind about their interventions. Thus, this study is a randomized and single-blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical ethics committee of Mashhad University of Medical Sciences
Street address
University St., Ghoraishy Building
City
Mashhad
Postal code
91375345
Approval date
2016-06-22, 1395/04/02
Ethics committee reference number
MUMS.fm.REC.1395.53
2
Ethics committee
Name of ethics committee
Added at 2016-07-22: Medical ethics committee of Mashhad University of Medical Sciences
Street address
Added at 2016-07-22: University St., Ghoraishy Building
City
Added at 2016-07-22: Mashhad
Postal code
Added at 2016-07-22:
Approval date
0623-12-31, 6/01/-1174
Ethics committee reference number
Added at 2016-07-22: MUMS.fm.REC.1395.80
Health conditions studied
1
Description of health condition studied
Malignant neoplasm of oesophagus
ICD-10 code
C15
ICD-10 code description
Malignant neoplasm of oesophagus
2
Description of health condition studied
Follow-up examination after combined treatment for malignant neoplasm
ICD-10 code
Z08.7
ICD-10 code description
Follow-up examination after combined treatment for malignant neoplasm
Primary outcomes
1
Description
clinical responce
Timepoint
4-6 weeks after complete of combined treatment
Method of measurement
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)
2
Description
pathologic responce
Timepoint
4-6weeks after complete of treatment
Method of measurement
according to pathologic findigs of esophagous specimen (complete Vs incompelet)
3
Description
R staging (residual of tumor)
Timepoint
intraoperative of eosophagectomy
Method of measurement
according to surgeon findigs when eosophagectomy is done (gross residue, microscopic residue, without residue)
Secondary outcomes
1
Description
heparin induced thrombocytopenia
Timepoint
before prescription of any course of chemotherapy
Method of measurement
according to CBC
Intervention groups
1
Description
In the intervention group, patients are going to receive subcutaneous enoxaparin (40 mg) daily concurrent with chemo-radiotherapy.
Category
Treatment - Drugs
2
Description
chemo-radiotherapy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Oncology clinic, Omid Hospital, Mashhad, Iran
Full name of responsible person
Dr. Taghizadeh Kermani, Ali
Street address
Department of Oncology, Omid Hospital, Mashhad University of Medical Sciences