| CTRI Number |
CTRI/2017/08/009318 [Registered on: 09/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Radiation Therapy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Chemotherapy followed by radiotherapy response assessment in muscle invasive urinary bladder carcinoma |
|
Scientific Title of Study
|
Impact of neoadjuvant chemotherapy on organ preservation in muscle invasive urinary bladder carcinoma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chinnababu D |
| Designation |
Senior resident |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER) |
| Address |
Room no:4, Department of Radiotherapy, PGIMER, Sector-12, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855803437 |
| Fax |
|
| Email |
chinnababudraksham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra Kumar |
| Designation |
Additional Professor |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER) |
| Address |
Room no:4, Department of Radiotherapy, PGIMER, Sector-12, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009393 |
| Fax |
|
| Email |
drnarendra74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chinna Babu D |
| Designation |
Senior resident |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER) |
| Address |
Room no:4, Department of Radiotherapy, PGIMER, Sector-12, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855803437 |
| Fax |
|
| Email |
chinnababudraksham@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research(PGIMER), Sector-12, Chandigarh-160012. |
|
|
Primary Sponsor
|
| Name |
NONE |
| Address |
Post Graduate Institute of Medical Education and Research(PGIMER), Sector-12, Chandigarh-160012. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Chinna babu D |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER) |
Room no:4, Department of Radiotherapy, PGIMER, Sector-12, Chandigarh.
Chandigarh
CHANDIGARH |
9855803437
chinnababudraksham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
healthy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
chemotherapy, radiotherapy, surgery |
20 patients were planned to be enrolled in this study from april 2014-October 2015. All patients were treated with 3cycles of Neoadjuvant chemotherapy with Inj. Gemcitabine 1.2gm/m2 on day 1 and day 15, Inj. Cisplatin 70mg/m2 on day 1 only .Chemotherapy was given with adequate hydration, and antiemitic prophylaxis in all patients, on day 1 and day15, 4weekly, for a total of3cycles. After 3cycles of chemotherapy, the patients were underwent radiological response assessment with RECIST criteria, by CECT chest, abdomen, pelvis and Cystoscopic assessment. Patients who had radiological Partial response (50%) underwent. Radical Radiotherapy 62Gy in 31 fractions with or without Concurrent chemotherapy with weekly Cisplatin. Patients who had Radiological Partial response (50%) patients or no response patients were treated by Radical Cystectomy followed by postoperative Radiation to a dose of 50Gy in 25fractions. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Muscle invasive bladder carcinoma,
2. Stage T2-T4, N0- N1,M0according to AJCC 2010 Staging.
3. Karnofsky Performance Status scale(KPS)>70.
4. All patients were explained about the protocol and a written informed consent was obtained.
|
|
| ExclusionCriteria |
| Details |
1. Non muscle invasive bladder carcinoma / Metastatic disease.
2. KPS <70
3. Significant comorbid conditions like Hypertension, Diabetes Mellitus, Coronary artery disease for more than 5 years.
4. Any other primary malignancy
5. Abnormal Haemogram: a. Haemoglobin < 10gm/dl, b. Platelet count< 100000/ cmm, c. Total leucocyte count < 3000/cmm.
6. Abnormal renal function test: a. Blood urea >50mg/dl, b. Serum creatinine >1.2mg/dl.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the response rate after neoadjuvant chemotherapy.
2.To assess the response rate after radical radiation therapy.
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| .To evaluate treatment related toxicities |
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/04/2014 |
| Date of Study Completion (India) |
30/10/2015 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
This trial is not published till now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Conservative
approaches in muscle invasive bladder carcinoma (MIBC) evolved recently with
the aim of avoiding surgery which may have a negative impact on the quality of
life. The non-surgical treatment has been traditionally reserved for patients
who are unfit for, or refuse radical cystectomy. But there is growing evidence
that, availability of new chemotherapeutic protocols and radiotherapy techniques have made bladder preservation a competitive alternative to
cystectomy in selected patients.
A
total 20 patients with urothelial carcinoma of urinary bladder of stage T2-T4, N0- N1,
M0 (AJCC 2010) who were fit for combined radiochemotherapy and
refused radical surgery were selected and enrolled. All patients were treated with three cycles of NACT.
After
NACT, 18 patients (90%) who had partial response (PR) >50% , received
radical radiation, and two patients (10%) who had PR <50%, underwent radical
cystectomy. All patients who received radiation showed complete response, six
weeks after RT. After median follow up of 26 months, 2 patients developed local recurrence, underwent salvage
cystectomy. One patient developed local and distant failure. Hematologic and non hematologic toxicities were
acceptable.
Conservative treatment in MIBC patients with NACT followed by RT provides
a high probability of local response with acceptable toxicity in properly
selected patients.
Our trial shows that organ preservation is a valid option in early stages of
MIBC |