| CTRI Number |
CTRI/2024/07/070458 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Low dose oral metronomic therapy in recurrent refractory uterine endometrial cancer |
|
Scientific Title of Study
|
Low dose Oral Metronomic Cyclophosphamide and Etoposide combination in Recurrent/Refractory High Grade Endometrial Cancer, a Single Arm Phase 2 Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhoor Singh |
| Designation |
Senior resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no. 160, first floor, department of Medical Oncology , BRA IRCH , AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
09001093991 |
| Fax |
|
| Email |
bhatibs2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Khurana |
| Designation |
Associate professor, department of Medical Oncolgy |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no. 160, first floor, department of Medical Oncology, BRA IRCH AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9769030180 |
| Fax |
|
| Email |
dr.sachinkhurana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhoor Singh |
| Designation |
Senior Resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no. 160, first floor, department of Medical Oncology, BRA IRCH AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9769030180 |
| Fax |
|
| Email |
bhatibs2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| All india institute of medical sciences, Ansari nagar New DELHI India ( pin code 110029). |
|
|
Primary Sponsor
|
| Name |
Dr Bhoor Singh |
| Address |
All in dia institute of medical sciences, Ansari nagar New Delhi (pin code 110029) |
| Type of Sponsor |
Other [SELF] |
|
|
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 Bhoor Singh |
AIIMS , New Delhi and National cancer institute AIIMS, Jhajjar Haryana |
Room no.160, first floor, department of Medical Oncology
South
DELHI |
9001093991
bhatibs2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
ORAL CYCLOPHOSPHAMIDE AND ORAL ETOPOSIDE |
Oral Cyclophosphamide 50mg/d D1-D21 q28d and Oral etoposide 50mg/d D1-D14 q28d in form of oral metronomic therapy to the patients with recurrent / refractory high grade endometrial cancer who has received One or more prior lines of therapy with at least one platinum based chemotherapeutic regimen, containing carboplatin or cisplatin with platinum free interval of less than 1 year.
Therapy will be continued till the progression of the disease or intolerable adverse effects. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. Histologically confirmed recurrent / refractory high grade endometrial cancer [endometroid/serous/carcinosarcoma/clear cell]
2. One or more prior lines of therapy with at least one platinum based chemotherapeutic regimen, containing carboplatin or cisplatin with platinum free interval of less than 1 year.
3. Written informed consent.
4. ECOG PS 0-2
5. Measurable disease with at least one target lesion which could be used for response evaluation as per RECIST 1.1 criteria
6. Adequate organ function
|
|
| ExclusionCriteria |
| Details |
1. Low grade [grade I/II] endometrial cancer
2. Patient who are eligible for hormonal therapy
3. Patients with recurrent carcinoma endometrium with platinum free interval of more than 1 year
4. Chemotherapy naïve patient [adjuvant/metastatic setting]
5. Patients who are eligible/affordable for immunotherapy
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess disease control rate [Clinical benifit rate ; complete responce + Partial Responce + stable disease] in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide and etoposide. |
Response assessment will be done after 3 cycles of cyclophosphamide and etoposide OMT using clinico-radiological (CECT) and biochemical assessment (if CA-125 and CA19.9 levels elevated at baseline).
Subsequently every 3 months response assessment will be done or earlier if apparent progressive disease.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the Objective Response Rate [ORR; Complete Response (CR) + Partial Response (PR)] [RECIST v1.1] the in recurrent high grade endometrial cancer with oral metronomic therapy with cyclophosphamide & etoposide.
2. To assess the Clinical Benefit Rate (CBR) will be defined as the percentage of patients who will achieve complete response, partial response, or at least six months of stable disease as a result of therapy.
3. To assess the Progression Free Survival (PFS) & Overall Survival (OS) censored at the end of study period.
4. To evaluate the change in Quality of Life (QOL) at different time points
5. To assess the treatment related adverse events using CTCAE v5.0.
|
Response assessment will be done after 3 cycles of cyclophosphamide & etoposide OMT using clinicoradiological (CECT) & biochemical assessment, if CA-125 & CA19.9 levels elevated at baseline.
Subsequently every 3 months response assessment will be done or earlier if apparent progressive disease.
|
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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 |
|
Date of First Enrollment (India)
|
22/07/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhatibs2001@gmail.com].
- For how long will this data be available start date provided 01-07-2014 and end date provided 31-12-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
Title: low dose oral metronomic cyclophosphamide and etoposide combination in recurrent/refractory high grade endometrial cancer , a single arm phase II study.
REVIEW OF LITRERATURE: Unklike the case of epithelial ovarian cancer the literature on the metronomic therapy used in uterine malignancy is sparse.
Rationale of the study: Non availability of standard 2nd line treatment for recurrent/refractory endometrial cancer , favorable toxicity profile of oral metronomic therapy, no data on this combination in endometrial cancer despite of high incidence and mortality RESEARCH HYPOTHESIS: low dose oral cyclophosphamide and etoposide combination will lead to ORR >20% in recurrent / refractory endometrial cancer. TYPE OF THE STUDY: INTERVENTIONAL PHASE OF THE STUDY : PHASE II STUDY DESIGN : SIMON PHASE II SINGLE ARM OPTIMAL STUDY DESIGN
ELIGIBLE POPULATION : High grade endometrial cancer [endometroid/serous/clear cell/carcinosarcoma] recurrent / refractory endometrial cancer with platinum free interval of less than 1 year.
|