| CTRI Number |
CTRI/2021/04/032958 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between two different modern techniques of radiotherapy in terms of side effects and disease control in cervical cancer patients. |
|
Scientific Title of Study
|
A prospective comparative study of IMRT (using VMAT technique) versus 3DCRT with respect to toxicity and loco-regional response in locally advanced cervical carcinoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sujan Kumar Ghosh |
| Designation |
DNB trainee |
| Affiliation |
Chittaranjan national cancer institute |
| Address |
CHITTARANJAN NATIONAL CANCER INSTITUTE, ROOM NUMBER-24, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY,
37-S.P.MUKHERJEE ROAD,KOLKATA-700026
Kolkata
WEST BENGAL
700026
India |
| Phone |
9831650137 |
| Fax |
|
| Email |
dr.sujankumarghosh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tapas Maji |
| Designation |
Head of the department of Radiotherapy, Chittaranjan national cancer institute |
| Affiliation |
Chittaranjan national cancer institute |
| Address |
CHITTARANJAN NATIONAL CANCER INSTITUTE, ROOM NUMBER-17, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY,
37-S.P.MUKHERJEE ROAD,KOLKATA-700026
Kolkata
WEST BENGAL
700026
India |
| Phone |
9432244844 |
| Fax |
|
| Email |
tapasmaji60@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sujan Kumar Ghosh |
| Designation |
DNB trainee |
| Affiliation |
Chittaranjan national cancer institute |
| Address |
CHITTARANJAN NATIONAL CANCER INSTITUTE, ROOM NUMBER-24, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY,
37-S.P.MUKHERJEE ROAD,KOLKATA-700026
Kolkata
WEST BENGAL
700026
India |
| Phone |
9831650137 |
| Fax |
|
| Email |
dr.sujankumarghosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| CHITTARANJAN NATIONAL CANCER INSTITUTE |
|
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Primary Sponsor
|
| Name |
Chittaranjan National Cancer Institute |
| Address |
37-S.P.MUKHERJEE ROAD,KOLKATA-700026 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sujan Kumar Ghosh |
CHITTARANJAN NATIONAL CANCER INSTITUTE |
ROOM NUMBER-24, GROUND FLOOR, DEPARTMENT OF RADIOTHERAPY,
37-S.P.MUKHERJEE ROAD,KOLKATA-700026
Kolkata
WEST BENGAL |
9831650137
dr.sujankumarghosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, Chittaranjan national cancer institute |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparison between 2 types of radiotherapy techniques in two arms i.e. 3D Conformal Radiotherapy and Intensity Modulated Radiotherapy(using VMAT technique) |
To assess toxicity and loco-regional response between the two arms using 3DCRT versus IMRT (using VMAT technique) in locally advanced cervical carcinoma. In both the arm patient will receive same radiotherapy dose, i.e.- 50 Gy in 25 fractions(2 Gy per fraction) by external beam radiotherapy in 5 weeks(5 days in a week) followed by brachytherapy 7 Gy per fraction weekly for 3 fractions in 3 weeks. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1) Histopathology confirmed primary carcinoma of cervix.
2) Histopathology- squamous cell carcinoma.
3) Intact and non-operated cervical carcinoma cases (wherever concurrent chemo-radiotherapy is
indicated).
4) FIGO stage IB3 to IIIB.
5) Age 18 yrs – 70 years.
6) No prior history of chemotherapy or pelvic radiotherapy.
7) WHO performance status grade 0 to 2
8) liver function test with in 2 times of upper normal level
9) hematological parameters with in normal limit and kidney function test within normal limit
10) Patients with no history or current clinical evidence of any Hematological or Bleeding
disorders.
11) HBsAG, Anti-HCV, HIV non-reactive patients.
12) No history of drug use which results in Hematological toxicity.
13) The patient who will understand and follow the instructions and must be able to participate in
the study for the entire period. |
|
| ExclusionCriteria |
| Details |
1) Age < 18 years and > 70 years.
2) Patients with WHO performance status grade> 2.
3) Post – op patients adviced to receive adjuvant radiotherapy.
4) Stages IA1 – IB2 and stages IVA-IVB patients.
5) Patients with pelvic and para-aortic nodal disease or who require extended field radiotherapy beyond the pelvis.
6) Patients with deranged liver function test and kidney function test parameters.
7) Severe, active co-morbidity, defined as follows:
A. History of Unstable angina and/or congestive heart failure requiring hospitalization within the last 6months.
B. History of myocardial infarction within the last 6 months.
C. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration to the study.
D. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
E. Clinical jaundice and/or history of bleeding disorder.
8) Patients who have already received radiation to pelvis and prior history of chemotherapy.
9) Patients not willing to take part in the study.
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To compare acute hematological, gastro-intestinal and genitourinary toxicities between IMRT (using VMAT technique) and 3DCRT in patients of cervical cancer (FIGO stage IB3-IIIB).
2) To compare loco-regional response between IMRT (using V-MAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB).
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare overall treatment time during EBRT due to toxicity between IMRT (using VMAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB).
2) To compare disease free survival between IMRT (using VMAT technique) and 3DCRT in cervical cancer (FIGO stage IB3-IIIB), within the short time span of the study.
|
3 years |
|
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Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Conventional pelvic radiotherapy techniques typically use opposed antero-posterior/ postero-anterior and lateral fields according to bony anatomy. Resulting in a box shaped dose distribution that encompasses both the target (eg. tumor, parametria, pelvic lymph nodes) and normal tissues (eg. Bowel, Rectum, Bladder, Bone marrow).The hematopoietic stem cells of bone marrow are very sensitive to radiation. It is shown that increased dose to the bone marrow and increased volume of bone marrow in the field of radiation can proportionately increase the risk of acute hematological toxicities. Nearly 50% of body bone marrow is in pelvic and neighboring bones which come in the field of radiation in the treatment of carcinoma cervix. The conventional two dimensional fields irradiate a large volume of bone marrow which in addition to myelotoxic effects of chemotherapy results in more severe hematological toxicities. With the introduction of CT based treatment planning, the technique of 3DCRT offers better target coverage and significantly reduces the amount of radiation exposure to bladder. However, this technique did not appreciably reduce the amount of radiation exposure to the intestines, rectum, bone marrow, In contrast to 3DCRT which uses uniform fields, IMRT (using VMAT technique) generates non-uniform fields to achieve better planning target volume coverage, while decreasing unnecessary radiation exposures to the normal organs including red marrow. IMRT (using VMAT technique) advantage has been proven in several anatomical sites such as head and neck cancers. Large and frequent changes in target positioning due to organ motion, uncertainties in target position and wide variation in methods have also resulted in a lack of consensus regarding the best IMRT (using VMAT technique) approach in gynecological cancer and the benefit of using IMRT (using VMAT technique) in the field of gynecological cancer is still under evaluation and there is potential to reduce toxicities. So, we will conduct a prospective study to compare the severity of acute gastro-intestinal, genito-urinary and hematological toxicities and loco-regional response between 3DCRT and IMRT (using VMAT technique.
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