| CTRI Number |
CTRI/2021/10/037690 [Registered on: 29/10/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
immuno-profiling in cervical cancer |
|
Scientific Title of Study
|
Cervical cancer tumor micro-environment immune-profiling and effect on early response to standard chemoradiotherapy in Indian patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pritee A Patil |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS New Delhi |
| Address |
Department of Radiation Oncology National Cancer Institute Badsa Jhajjar
Jhajjar
HARYANA
124105
India |
| Phone |
9870320544 |
| Fax |
|
| Email |
drpritee184@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pritee A Patil |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS New Delhi |
| Address |
Department of Radiation Oncology National Cancer Institute Badsa Jhajjar
Jhajjar
HARYANA
124105
India |
| Phone |
9870320544 |
| Fax |
|
| Email |
drpritee184@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pritee A Patil |
| Designation |
Assistant Professor |
| Affiliation |
NCI AIIMS New Delhi |
| Address |
Department of Radiation Oncology National Cancer Institute Badsa Jhajjar
Jhajjar
HARYANA
124105
India |
| Phone |
9870320544 |
| Fax |
|
| Email |
drpritee184@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Ansari Nagar New Delhi 110029 |
| 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 Pritee A Patil |
NCI |
Department of Radiation Oncology Badsa Jhajjar
Jhajjar
HARYANA |
9870320544
drpritee184@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. FIGO 2008 stage IB2, IIB, IIIB disease.
2. Age 18 years or older and <65 years
3. ECOG performance status 0 - 2
4. Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the cervix
5. HB> 9 g/dL; ANC > 1000 / mm3; Plt > 1,00,000/ mm3
6. Bilirubin ≤ 1.5 x ULN ,
AST or ALT ≤ 2.5 x ULN
7. Adequate renal function: creatinine ≤ ULN (CTC Grade 0) or calculated creatinine clearance (Cockcroft-Gault Formula) ≥ 60ml/min or ≥ 50 ml/min by EDTA creatinine clearance
8. Written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Any previous pelvic radiotherapy
2. Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven or ≥ 10 mm short axis diameter on CT)
3. FIGO STAGE IIIA
4. Patients assessed at presentation as requiring interstitial brachytherapy treatment
5. Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfills the required inclusion criteria
6. Evidence of metastases
7. Diagnosis of Crohn’s disease or ulcerative colitis
8. Peripheral neuropathy > grade 2 (as per CTCAE)
9. Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervix cancer therapy
10. Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years
11. Patients who are pregnant or lactating
12. Any contraindication to cisplatin
13. Serious uncontrolled medical condition
14. HIV positive
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Categorize locally advanced cervical cancers into immune inflamed and immune suppressed based on immune cell infiltration
b. Tumour micro-environment inflammatory cells immune profiling
c. Evaluate response rates to standard chemoradiotherapy and progression free survival versus immune cell infiltration
|
Eighteen months and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2021 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cervical cancer is
the most common cancer among females in rural India. The standard treatment is
chemo-radiotherapy. Five year survival remains around 50% only in locally
advanced cervical cancer with most patients recurring within the initial 2
years. Immune evasion by various mechanisms is one of the ways of resistance to
treatment in various cancers. Immune profiling of tumour micro-environment
(TME) before treatment will help identify tumours that are inherently
immunosuppressed and therefore expected to have poor responses to standard
anti-cancer treatment. This immune profiling will also help in future to conduct
trials using hypofractionated (> 5 Gy/ fraction) radiotherapy to make the
TME immune-inflamed. In the proposed pilot study, 60 patients of
locally advanced (Stage IB2 – IIIB) cervical cancer will be recruited for
immunoprofiling and will be treated with standard chemoradiation followed by
brachytherapy. Paraffin embedded primary tumour biopsy will be subjected to
immunohistochemistry (IHC). IHC for CD8 and regulatory T cell infiltration in
tumour (CD4 and FOXP3) will be performed. Similarly M2 macrophages will be
identified by IHC for CD 68. Early clinical response will be assessed at the
end of external beam radiotherapy and 3 months after completion of
brachytherapy. Progression free survival at 18 and 24 months will be noted and
correlated with the immune profile of pretreatment biopsy. Clinical responses
will be graded as progressive disease, stable disease, partial response and
complete response. Uni-variate analysis by log rank test for survival data will
be attempted. |