Comparative of neoadjuvant chemotherapy fallowed by definitive chemo-radiotherapy and adjuvant chemotherapy versus definitive chemoradiotherapy alone in locally advanced cervical cancer
Determining and comparing the response rate and side effects
Design
Prospective non-randomized clinical trial with 70 patients will be divided into two groups.
Settings and conduct
Patients with advanced cervical cancer in Imam Hossein Hospital will be divided into two groups. In the study group, they will first undergo six courses of chemotherapy, then perfusion MRI evaluation, and in case of clinical response, chemotherapy will continue for up to nine weekly cycles. Patients who did not respond to neoadjuvant chemotherapy will receive six weeks of adjuvant chemotherapy. Patients who have not responded to neoadjuvant chemotherapy will receive immediate standard chemoradiation
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with advanced cervical cancer (FIGO Ib3-II-III-IVA) ages between 20 to 80 years.
Exclusion criteria: previous treatment with neoadjuvant chemotherapy; history of last surgical treatment; history of radiotherapy in the pelvis and abdomen.
Intervention groups
Evaluation and comparison of two treatment protocols including neoadjuvant and adjuvant chemotherapy with definite chemoradiotherapy compared to definitive chemoradiotherapy alone in patients with advanced cervical cancer
Main outcome variables
Improve response to treatment; improve disease-free survival for one and two years; reduce side effects of radiation therapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211011052730N1
Registration date:2024-01-02, 1402/10/12
Registration timing:prospective
Last update:2024-01-02, 1402/10/12
Update count:0
Registration date
2024-01-02, 1402/10/12
Registrant information
Name
robab anbiaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 3000
Email address
anbiaee-mm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-29, 1402/12/10
Expected recruitment end date
2026-03-01, 1404/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of neoadjuvant chemotherapy fallowed by definitive chemo-radiotherapy and adjuvant chemotherapy versus definitive chemoradiotherapy alone in locally advanced cervical cancer
Public title
Comparison of chemotherapy before and after definitive chemotherapy-radiotherapy with definitive chemotherapy-radiotherapy alone in patients with advanced cervical cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with advanced cervical cancer (FIGO Ib3-II-III-IVA)
Exclusion criteria:
Previous treatment with neoadjuvant chemotherapy
History of previous surgical treatment
History of radiotherapy in the pelvis and abdomen
Age
From 20 years old to 80 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
35
More than 1 sample in each individual
Number of samples in each individual:
35
35 patients in the control group who will receive standard definitive chemoradiation treatment and 35 patients in the treatment group who will receive neoadjuvant and adjuvant chemotherapy with definitive chemoradiation
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Shahid Shahriari Square, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2021-11-14, 1400/08/23
Ethics committee reference number
IR.SBMU.MSP.REC.1400.557
Health conditions studied
1
Description of health condition studied
Cancer of cervix
ICD-10 code
C53.0
ICD-10 code description
Malignant neoplasm of endocervix
Primary outcomes
1
Description
Disease free survival
Timepoint
One year and two year after intervention
Method of measurement
Physical exam and pelvic MRI
2
Description
Improved treatment response
Timepoint
One year and two year after intervention
Method of measurement
Physical exam and pelvic MRI
3
Description
reduction of radiation therapy-related side effects.
Timepoint
One year and two year after intervention
Method of measurement
History and Physical exam and pelvic MRI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One group will undergo a neoadjuvant protocol along with concomitant chemoradiotherapy. Initially, patients will receive four cycles of weekly carboplatin AUC=2 and paclitaxel 80mg/m2, followed by an evaluation with abdominopelvic diffusion MRI to assess the response rate. Patients showing a favorable response will continue chemotherapy for up to nine weekly cycles. Those who do not respond favorably will immediately commence definitive chemoradiotherapy with cisplatin 40mg/m2 concurrently with 40 to 45Gy EBRT and a 12 to 20Gy boost to the gross node if necessary. Based on indications, they will then receive 30Gy in 3 fractionations over 3 weeks of HDR brachytherapy. Individuals who respond to neoadjuvant chemotherapy will be treated with adjuvant six cycles of weekly carboplatin and paclitaxel. At the conclusion of all treatment stages, all patients will enter the follow-up phase and will be evaluated every three months by gynecologists and radiation oncologists
Category
Treatment - Drugs
2
Description
Control group: The second group will undergo treatment with definitive chemoradiotherapy, including cisplatin 40mg/m2 concurrently with 40 to 45Gy EBRT and a 12 to 20Gy boost to the gross node if necessary. Based on indications, they will receive 30Gy in 3 fractions over 3 weeks of HDR brachytherapy alone. At the end of all treatment stages, patients will enter the follow-up phase and will be evaluated every three months by gynecologists and radiation oncologists
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Robab Anbiaee
Street address
South Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
anbiaee-mm@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra bakhtiyari
Street address
Shahid Beheshti University of Medical Sciences, Shahid Shahriari Square, Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 7343 2320
Email
zahrabakhtiyari545@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahrzad Ebrahimi
Position
Radioncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam Hossein Hospita, lSouth Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
shahrzadebrahimi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Robab Anbiaee
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Imam Hossein Hospita, lSouth Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
anbiaee-mm@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahrzad Ebrahimi
Position
Radioncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam Hossein Hospita, lSouth Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
shahrzadebrahimi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Chemotherapy and radiotherapy protocol. Examinations and pathology and patient imaging
When the data will become available and for how long
After printing the results
To whom data/document is available
Researchers in scientific and academic institutions
Under which criteria data/document could be used
Provide an official license from the relevant scientific and academic institution
From where data/document is obtainable
shahrzad.ebrahimi1366@gmail.com
What processes are involved for a request to access data/document
Email to the address mentioned above and after confirmation and confirmation of the validity of the letter of introduction of the documents will be emailed to him/her