| CTRI Number |
CTRI/2020/02/023402 [Registered on: 17/02/2020] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
choice between paclitaxel or carboplatin in cisplatin ineligible advanced urinary bladder cancer |
|
Scientific Title of Study
|
Gemcitabine and Carboplatin versus Gemcitabine and Paclitaxel Chemotherapy in Cisplatin Ineligible Advanced Stage Urothelial Cancers: A Prospective Randomized Control Study. |
| Trial Acronym |
CAUR CAP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARMOD KUMAR |
| Designation |
ACADEMIC SENIOR RSIDENT (DM MEDICAL ONCOLOGY)) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH |
| Address |
DEPARTMENT OF MEDICAL ONCOLOGY HEMATOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH
VIRBHADRA MARG
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810200367 |
| Fax |
|
| Email |
parmodkpal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMIT SEHRAWAT |
| Designation |
ASSISTANT PROFESSOR (MEDICAL ONCOLOGY) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH |
| Address |
DEPARTMENT OF MEDICAL ONCOLOGY HEMATOLOGY.
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH
VIRBHADRA MARG
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9958474477 |
| Fax |
|
| Email |
dramitsehrawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PARMOD KUMAR |
| Designation |
ACADEMIC SENIOR RESIDENT (DM MEDICAL ONCOLOGY) |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH |
| Address |
DEPARTMENT OF MEDICAL ONCOLOGY HEMATOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH
VIRBHADRA MARG
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9810200367 |
| Fax |
|
| Email |
parmodkpal@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RISHIKESH |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH
VIRBHADRA MARG
RISHIKESH
UTTARANCHAL |
| 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 |
| PARMOD KUMAR |
ALL INDIA INSITUTE OF MEDICAL SCIENCES. RISHIKESH |
DEPARTMENT OF MEDICAL ONCOLOGY HEMATOLOGY
ALL INDIA INSTITUTE OF MEDICAL SCIENCES. RISHIKESH
VIRBHADRA MARG
Dehradun
UTTARANCHAL |
9810200367
parmodkpal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMMITTEE. AIIMS RISHIKESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not comparator agent |
The two intervention protocols are already approved for treatment for cisplatin ineligible patient with equal strength of recoomandation, they will be compared with each other. |
| Intervention |
GEMCITABINE AND CARBOPLATIN CHEMOTHERAPY PROTOCOL (GEM-CAR) |
PREMEDICATIONS:
Cap APREPITANT 125 mg PO 30 minutes before day 1 of Gem-Car
Inj ONDANSETRON 16mg and DEXAMETHASONE 12 mg in 100ml NS IV over 30mins day 1 and day 8
Additional antiemetic if required.
TREATMENT:
Drug Dose Administration Guideline
INJ Gemcitabine 1000 mg/m2 on day 1 and 8 IV in 250 mL NS over 30 minutes
INJ Carboplatin AUC4.5 on day 1 only IV in 500 mL D-5% /NS over 1 hours
Post Chemotherapy medication:
The antiemetic therapy should continue for at least 2 days after day 1.
Tab Dexamethasone 8 mg PO once daily for 2 days, after day1 and day8
Tab Ondansetron 4mg PO thrice daily, 3 days post Gem-Car, after day1 and day8
Cap APREPITANT 80 mg PO day 2 and day 3 only after day1
Inj. GCSF 300mcg S/C 24 hours after chemotherapy if required.
Repeat every 21 days x 8 cycles.
|
| Intervention |
GEMCITABINE AND PACLITAXEL CHEMOTHERAPY PROTOCOL (GEM-PAC) |
PREMEDITATION:
45 minutes prior to Paclitaxel: DEXAMETHASONE 12 mg IV with ONDANSETRON 16mg in 100 mL NS over 15 minutes.
30 minutes prior to Paclitaxel: DIPHENHYDRAMINE 50 mg IV and RANITIDINE 50 mg IV in 50 mL NS over 20 minutes (compatible up to 3 hours when mixed in bag)
Additional antiemetic if required.
TREATMENT:
Drug Dose Administration Guideline
INJ Paclitaxel 175mg/m2 on day 1 IV in 500 mL NS over 3 hours
(use glass bottle and PVC free tubing with 0.22 micron or smaller in-line filter)
INJ Gemcitabine 1000 mg/m2 on day 1 and 8 IV in 250 mL NS over 30 minutes
Post Chemotherapy medication:
The antiemetic therapy will continue for at least 2 days after day 1.
Tab Dexamethasone 8 mg PO once daily for 2 days, after day1 and day8
Tab Ondansetron 4mg PO thrice daily, 3 days post Gem-Car, after day1 and day8
Inj. GCSF 300mcg S/C 24 hours after chemotherapy if required.
Repeat every 21days x 8cycles. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 years and above
2.ECOG performance status 0,1,2
3.Histologically confirmed advanced urothelial cancer of the urethra, bladder, or upper urinary tracts.
4.Radiologically confirmed unresectable or metastatic disease
5.Estimated GFR less than 60 mL/min as measured by the Cockcroft-Gault method.
6.Left ventricular ejection fraction 40% and above
7.Chemotherapy naïve patients
|
|
| ExclusionCriteria |
| Details |
1.Brain metastasis
2.End-stage kidney disease requiring haemodialysis
3.New York Heart Association(NYHA)grade III or IV 4.Congestive heart failure, or history of unstable angina/ myocardial infarction within six months prior to study entry
5.Grade 2 or worse peripheral neuropathy
6.Serum SGOT/SGPT levels >5 times the upper normal limits (UNL) provided, Serum Bilirubin (Total) >3 times the UNL.
7.Any acquired immunodeficiency state
8.Presence of second malignancy
9.Pregnant or Lactating females.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time defined progresion free survial(T-PFS) will be compared among the patients who are randomized either to Gemcitabine and Carboplatin (GEM-CAR) or Gemcitabine and Paclitaxel (GEM-PAC)chemotherapy after specific treatment intervals. |
After 4 cycles OF chemo-therapies and after 8 cycles chemo-therapies. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Radiological objective response rate (ORR) of patients in the two arms after specific treatment period. |
After 4 cycles of chemo-therapies and after 8 cycles of chemo-therapies. |
| To compare the safety profile of Gemcitabine and Carboplatin (GEM-CAR)combination chemotherapy with safety profile of Gemcitabine AND Paclitaxel (GEM-PAC)combination chemotherapy among the patients after specific treatment period. |
After 4 cycles of chemo-therapies and after 8 cycles of chemo-therapies. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
20/02/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Globally bladder cancer is rank 7th and in India it rank 18th in cancer related deaths. There is an urgent need for research for treatment option in cisplatin ineligible advance stage bladder cancer specially in resource limited settings since immune therapy is financially not a viable option. The most frequent chemotherapy protocols used in cisplatin ineligible advanced stage bladder cancer are gemcitabine with carboplatin and gemcitabine with paclitaxel. However these two combinations were not compared in prospective randomized design. This study is a single center open label prospectively randomized study. Total 60 patient who will be randomly and equally divided into two arm. One will be treated with gemcitabine with carboplatin and other with gemcitabine with paclitaxel. The aim of study is to find which one among the two chemotherapy drug protocol is of optimal choice in terms of disease control and drug safety.
|