CTRI Number |
CTRI/2016/12/007605 [Registered on: 22/12/2016] Trial Registered Prospectively |
Last Modified On: |
03/02/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
study to compare effectiveness and safety of two regimes in advanced stage non small cell lung cancer. |
Scientific Title of Study
|
A Phase III Open label Randomized control study to compare efficacy and safety of Pemetrexed-Carboplatin versus Paclitaxel-Carboplatin as induction regimen in advanced Non-squamous Non-Small-Cell lung cancer |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR PRABHAT SINGH MALIK |
Designation |
ASSITANT PROFESSOR |
Affiliation |
DR. BRAIRCH, AIIMS |
Address |
ROOM NO 245, 2ND FLOOR, DR B. R. AMBEDKAR INSTITUTE ROTARY CANCER HOSPITAL, AIIMS, ANSARI NAGAR, NEW DELHI
New Delhi DELHI 110029 India |
Phone |
9968325318 |
Fax |
|
Email |
drprabhatsm@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR AJAY YADAV |
Designation |
SENIOR RESIDENT(DM STUDENT) |
Affiliation |
DR. BRAIRCH, AIIMS |
Address |
ROOM NO 245, 2ND FLOOR, DR B. R. AMBEDKAR INSTITUTE ROTARY CANCER HOSPITAL, AIIMS, ANSARI NAGAR, NEW DELHI
New Delhi DELHI 110029 India |
Phone |
8826914083 |
Fax |
|
Email |
ajayalwar01@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR PRABHAT SINGH MALIK |
Designation |
ASSITANT PROFESSOR |
Affiliation |
DR. BRAIRCH, AIIMS |
Address |
ROOM NO 245, 2ND FLOOR, DR B. R. AMBEDKAR INSTITUTE ROTARY CANCER HOSPITAL, AIIMS, ANSARI NAGAR, NEW DELHI
DELHI 110029 India |
Phone |
9968325318 |
Fax |
|
Email |
drprabhatsm@gmail.com |
|
Source of Monetary or Material Support
|
All INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
|
Primary Sponsor
|
Name |
All INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
Address |
All INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI ANSARI NAGAR,NEW DELHI |
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 |
DR PRABHAT SINGH MALIK |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
DEPARTMENT OF MEDICAL ONCOLOGY, DR. BR AMBEDKER INSTITUTE ROTARY CANCER HOSPITAL New Delhi DELHI |
9968325318
drprabhatsm@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS, NEW DELHI |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
ADVANCED STAGE NON SQUAMOUS NON SMALL CELL LUNG CANCER, (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Paclitaxel WITH
Carboplatin |
Paclitaxel 80 mg/m2 in 250 ml normal saline i.v. over 1 hour on Day-1, Day-8 and Day 15
– Carboplatin AUC-5 in 5% dexrose i.v. over 2 hour on Day-1 of 28 days cycle, total 4 cycles |
Intervention |
Pemetrexed WITH Carboplatin |
Pemetrexed (500 mg/m2) in 100 ml normal saline i.v. over 10 minute on day 1 of 21 days cycle
Carboplatin at dose of (AUC -5) in 5 % dexrose i.v. over 2 hour on day 1 of 21 days cycle
induction therapy include - 4 cycles at 3 week interval
(Folate and vit-B12 supplementation with each cycle of chemotherapy) |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
-Age 18-65 years
• Tissue diagnosis of Non-squamous Non-small cell lung cancer
• Stage IIIB (not amenable for radical CTRT) and stage IV
• Performance status ECOG 0, 1 and 2
• Normal renal and hepatic functions
– Creatinine clearance >50ml/min
– SGOT and SGPT < 2.5times of ULN |
|
ExclusionCriteria |
Details |
• Patients who have received prior chemotherapy
• Already known EGFR/ALK mutation, if being considered for TKI
• Symptomatic brain metastasis (Asymptomatic brain metastasis and stabilized brain
metastasis after WBRT would be considered)
• Immunosuppression (HIV, or other immunosuppressant medication)
• Symptomatic neuropathy |
|
Method of Generating Random Sequence
|
Stratified block randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To compare Progression Free Survival in both arms |
AFTER FOUR CYLES OF INDUCTION CHEMOTHERAPY |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To compare overall response rate in both arms
2. To compare toxicity profile in both arms
3. To compare Overall Survival in both arms
4. To compare disease control rate (CR/PR/SD) between the two induction treatment arms
5. To assess role of TS level and FRA level as predictive biomarker |
AT THE END OF THE INDUCTION CHEMOTHERAPY |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "180"
Final Enrollment numbers achieved (India)="180" |
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
|
26/12/2016 |
Date of Study Completion (India) |
31/01/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Pemetrexed-Carboplatin Versus Paclitaxel (Weekly)-Carboplatin as First Line Chemotherapy in Advanced Non-Squamous NSCLC
Malik P, Yadav A, Jain D et al. J Thorac Oncol. 2019;14(10 S): S354-357. |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Lung cancer is the leading cause of cancer-related deaths worldwide. Non-small cell lung cancer (NSCLC), accounts for about 85% of all lung cancers. Platinum base chemotherapy is the standard first-line treatment for patients of advanced NSCLC who are negative for the EGFR mutation and ALK rearrangement. There are various Cisplatin and Carboplatin based regimen approved for treatment of this group. To know which regimen is better Schiller et al, conducted a randomized clinical trial. In this trial they compared the efficacy of four doublet regimens Cisplatin plus gemcitabine, cisplatin plus docetaxel, carboplatin plus paclitaxel, or cisplatin plus paclitaxel in patients with advanced non–small-cell lung cancer. None of four chemotherapy regimens offered a significant advantage over the others. In a phase III study Scagliotti et al. found that pemetrexed plus cisplatin was noninferior to gemcitabine plus cisplatin in unselected patients with advanced-stage NSCLC. On subgroup analysis survival was significantly superior for patients with non-squamous histology who were treated with pemetrexed plus cisplatin. In phase III RCT (Point Break trial) Patel et al. compared the efficacy and safety of pemetrexed plus carboplatin plus bevacizumab followed by pemetrexed plus bevacizumab with paclitaxel plus carboplatin plus bevacizumab followed by bevacizumab in patients with advanced nonsquamous non–small-cell lung cancer. There was no difference in overall survival but PFS was significantly improved with PemCBev. There is no trial that has compared efficacy and safety of Paclitaxel-Carboplatin versus Pemetrexed-Carboplatin. In current study we will compare the efficacy and safety of Pemetrexed-Carboplatin versus Paclitaxel-Carboplatin as induction regimen in advanced Non-squamous Non-Small-Cell lung cancer. We hypothesized that in advanced non-squamous NSCLC, four cycles of induction chemotherapy with pemetrexed and carboplatin is superior to 4 cycles of paclitaxel and carboplatin in terms of progression free survival. Several clinical trials have shown that maintenance chemotherapy is beneficial in non squamous NSCLC. Several recent studies reported that low TYMS expression was associated with better response and/or survival when treated with pemtrexed-based regimens in NSCLC patients. But some other studies did not show the significant association between TYMS expression and efficacy of pemtredxed-based chemotherapy in NSCLC. Folate receptor alpha is a glycosyl phosphatidyl inositol (GPI) anchored cell surface protein that assists in uptake of antifolates via receptor-mediated endocytosis. Some studies reported that High FRA expression associated with better response to pemetrexe. In our study we will also assess role of TS level and FRA level as predictive biomarker.
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