Protocol summary

Summary
1. Objectives: To evaluate the pathologic response, treatment complications, and overall survival in patients with cervical cancer who are treated by neo-adjuvant chemotherapy and surgery. 2. Design: The study is single-grouped, non-blinded, one-centered, and in phase two of clinical trials. 3. Setting and conduct: A total of 30 patients will be selected by convenience sampling method from patients treated in the Radiation Oncology Ward of Imam Reza Hospital in Mashhad. 4. Major inclusion criteria: women aged between 18 and 70 years; definitive pathologic diagnosis of squamous cell carcinoma; and being in stages IB2, IIA2, and IIB according to the International Federation of Gynecology and Obstetrics classification. Main exclusion criteria: history of injection of chemotherapy drug during the four weeks preceding the study; and serious comorbidities such as cardiac disease, poorly controlled diabetes mellitus, malignant hypertension, or bleeding tendency. 5. Intervention: Pretreatment evaluation includes examination, pelvic magnetic resonance imaging, abdominal sonography, and chest x-ray. Patients receive three one-week periods of neo-adjuvant chemotherapy with paclitaxel (135 milligrams per square meter) on day 1 and cisplatin (75 milligrams per square meter) on day 2 every three weeks for three cycles. Patients without desirable response to chemotherapy will undergo standard pelvic chemoradiotherapy. In case the disease worsens in the 4 to 6 weeks later, the patient will undergo Wertham surgery along with three further chemotherapy cycles. The patients will be candidate for postoperative adjuvant radiation in case they have positive surgical margins, lymph nodes or parametric involvement, or at least two of the following factors: deep stromal invasion, lymphovascular invasion, or size greater than 4 centimeters in the histopathology report of the surgical specimen. 6. Main outcome measures: Pathologic response of the tumor to treatment will be assessed at the first presentation, after each cycle, and after surgery. Complication of chemoradiotherapy (e.g., nausea, vomit, neutropenia, edema, and neauropathy) will be evaluated after each cycle. Overall survival will be assessed one year after initiation of intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017090236033N1
Registration date: 2017-10-22, 1396/07/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-22, 1396/07/30
Registrant information
Name
Elahe Aghel
Name of organization / entity
Omid Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 6936
Email address
aghele941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellery for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Inquiry into pathologic response, complications, and overall survival in patients with locally advanced cervical cancer treated by neo-adjuvant chemotherapy and surgery
Public title
Pathologic response, side-effects, and overall survival in cervical cancer under treatment with neo-adjuvant chemotherapy and surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Definitive pathologic diagnosis of squamous cell carcinoma; stages IB2, IIA2, and IIB based on the International Federation of Gynecology and Obstetrics classification; age between 18 and 70 years; World Health Organization performance of grade 2 or lower; adequate renal and hepatic function and bone marrow reserve (i.e., absolute granulocyte count equal to or above 2×103 per liter, platelet count equal to or above 100×103 per liter; hemoglobin equal to or above 8.0 grams per deciliter, and glomerular filtration rate equal to or above 50); feasibility of follow-up in the ordered time; and informed consent. Exclusion criteria: history of injection of chemotherapy drug in four weeks before study; serious comorbidities, for example, cardiac disease, poorly controlled diabetes mellitus, malignant hypertension, or bleeding tendency; overt infection; multiple concurrent active cancers; neuropathy grade 2 or greater; pregnancy; and history of serious hypersensitivity or allergy to cisplatin and paclitaxel.
Age
From 18 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice-chancellery for Reasearch, Mashhad University of Medical Sciences, Daneshgah Ave.,
City
Mashhad
Postal code
Approval date
2016-12-08, 1395/09/18
Ethics committee reference number
IR.MUMS.fm.REC.1395.405

Health conditions studied

1

Description of health condition studied
locally advanced cervical cancer
ICD-10 code
C53
ICD-10 code description
Malignant neoplasm of cervix uteri

Primary outcomes

1

Description
edema
Timepoint
after each course of chemotherapy
Method of measurement
Clinical examination

2

Description
Clinical response of tumor to treatment
Timepoint
At the first presentation, after each cycle of chemotherapy, and after surgery
Method of measurement
Physical examination and pathology

3

Description
Overall survival
Timepoint
On year after initiation of treatment
Method of measurement
Physical examination

4

Description
Nausea
Timepoint
after each course of chemotherapy
Method of measurement
Physical examination

5

Description
Vomit
Timepoint
after each course of chemotherapy
Method of measurement
Physical examination

6

Description
neutropenia
Timepoint
after each course of chemotherapy
Method of measurement
complete blood count

7

Description
Neuropathy
Timepoint
after each course of chemotherapy
Method of measurement
Clinical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group: The study has a single group. Pretreatment evaluation includes examination, pelvic magnetic resonance imaging, abdominal sonography, and chest x-ray. Patients receive three one-week periods of neo-adjuvant chemotherapy with paclitaxel (135 milligrams per square meter) on day 1 and cisplatin (75 milligrams per square meter) on day 2 every three weeks for three cycles. Patients without desirable response to chemotherapy will undergo standard pelvic chemoradiotherapy. In case the disease worsens in the 4 to 6 weeks later, the patient will undergo Wertham surgery along with three further chemotherapy cycles. The patients will be candidate for postoperative adjuvant radiation in case they have positive surgical margins, lymph nodes or parametric involvement, or at least two of the following factors: deep stromal invasion, lymphovascular invasion, or size greater than 4 centimeters in the histopathology report of the surgical specimen. Pathologic response of the tumor to treatment will be assessed at the first presentation, after each cycle, and after surgery. Complication of chemoradiotherapy (e.g., nausea, vomit, neutropenia, edema, and neauropathy) will be evaluated after each cycle. Overall survival will be assessed one year after initiation of intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Radiation Oncology Ward of Imam Reza Hospital
Full name of responsible person
Dr Elahe Aghel
Street address
Radiation Oncology Ward, Imam Reza Hospital, Ibn-Sina Ave.,
City
Mashhad,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellery for Research of Mashhad University of Medicla Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice-chancellery of Reasearch and Technology, Mashhad University of Medical Sciences, Daneshgah Ave.,
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery for Research of Mashhad University of Medicla Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Elahe Aghel
Position
Resident of Radiation Oncology
Other areas of specialty/work
Street address
Radiation Oncology Ward, Imam Reza Hospital, Ibn-Sina Ave.,
City
Mashhad,
Postal code
Phone
+98 51 3842 6933
Fax
Email
aghele941@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sceinces
Full name of responsible person
Dr Sare Hossaini
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Daneshgah Ave.,
City
Mashhad,
Postal code
Phone
+98 51 3842 6936
Fax
Email
Hossainis@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Vice-chancellery of Education, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
roozgar@bums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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