| CTRI Number |
CTRI/2018/04/013460 [Registered on: 24/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
21/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison Of Vaginal Gauze Packing Technique With or Without Balloon in Brachytherapy Of Cervical Cancer. |
|
Scientific Title of Study
|
Comparison Of Vaginal Gauze Packing Technique With or Without Balloon In High Dose Rate Brachytherapy Of Uterine Cervical Cancer- A Crossover Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagadesan P |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Education and Research |
| Address |
DEPARTMENT OF RADIOTHERAPY,REGIONAL CANCER CENTRE, JIPMER.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7418218771 |
| Fax |
|
| Email |
drjagadesanp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rishanthini D |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Education and Research |
| Address |
RADIOTHERAPY,REGIONAL CANCER CENTRE, JIPMER.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894994039 |
| Fax |
|
| Email |
rishanthinid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rishanthini D |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Jawaharlal Institute of Postgraduate Education and Research |
| Address |
RADIOTHERAPY,REGIONAL CANCER CENTRE, JIPMER.
Mahe
PONDICHERRY
605006
India |
| Phone |
9894994039 |
| Fax |
|
| Email |
rishanthinid@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Education and Research |
| Address |
Gorimedu, Pondicherry 605006. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RISHANTHINI D |
JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH |
HDR BRACHYTHERAPY UNIT, DEPARTMENT OF RADIOTHERAPY, REGIONAL CANCER CENTRE, JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH.
Pondicherry
PONDICHERRY |
9894994039
rishanthinid@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CARCINOMA CERVIX POST EXTERNAL BEAM RADIOTHERAPY., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMBINED VAGINAL FOLEYS BALLOON AND GAUZE PACKING |
ONE FRACTION WILL BE DELIVERED WITH 20Fr FOLEYS CATHETER THREADED ON TO UTERINE TANDEM AND BALLOON INFLATED WITH 30CC SALINE IN ADDITION TO STANDARD VAGINAL GAUZE PACKING. TOTAL PROCEDURE AND TREATMENT TIME PER FRACTION IS 2 TO 3 HOURS. INTERVAL BETWEEN TWO FRACTIONS IS 1 WEEK. |
| Comparator Agent |
VAGINAL GAUZE PACKING |
ONE FRACTION WILL BE DELIVERED WITH VAGINAL GAUZE PACKING ALONE.TOTAL PROCEDURE AND TREATMENT TIME PER FRACTION IS 2 TO 3 HOURS. INTERVAL BETWEEN TWO FRACTIONS IS 1 WEEK. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients with uterine cervical cancer who have completed external beam radiotherapy and are found fit for intracavitary brachytherapy. |
|
| ExclusionCriteria |
| Details |
Patients with an ECOG Performance status >2.
Patients who had undergone previous pelvic surgery.
Patients who had undergone previous radiation therapy.
Age less than 18 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rectal and bladder radiation doses, expressed as maximum doses received to
respective organ volumes of 0.5cc,1cc and 2cc, as calculated in the CT-based
brachytherapy treatment plan. |
1st and 2nd fractions of brachytherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Rectal and bladder radiation doses, expressed as maximum doses received to
respective organ volumes of 0.5cc,1cc and 2cc, as calculated in the CT-based
brachytherapy treatment plan before and after brachytherapy treatment. |
1st and 2nd fractions of brachytherapy |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/03/2017 |
| Date of Study Completion (India) |
25/04/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study compares vaginal gauze packing technique with or without balloon in the treatment of uterine cervical cancer using high dose rate intracavitary brachytherapy. This is a randomized controlled trial with crossover design. 36 patients will be recruited after completion of external beam radiotherapy and are eligible for intracavitary brachytherapy. They will be randomized to receive first session of brachytherapy with either the control (vaginal gauze packing alone) or experimental (combined vaginal balloon and gauze packing) techniques. For the second session of brachytherapy, patients will be crossed over. The last session of brachytherapy will not be considered as a part of the trial. CT based planning will be done and dosimetric data will be collected for the bladder and rectum. A comparison will be made for the bladder and rectal dose between the two techniques. In addition, pre and post-procedural CT scans will be done to evaluate the applicator stability. |