CTRI

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CTRI Number

CTRI/2018/01/011599 [Registered on: 30/01/2018] Trial Registered Retrospectively

Last Modified On:

29/01/2018

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Single Arm Study

Public Title of Study

ACUTE TOXICITY OF EXTENDED FIELD INTENSITY MODULATED RADIOTHERAPY AND CONCURRENT CHEMOTHERAPY IN HIGH RISK CERVICAL CANCER PATIENTS

Scientific Title of Study

EVALUATION OF ACUTE TOXICITY OF EXTENDED FIELD INTENSITY MODULATED RADIOTHERAPY WITH CONCURRENT CISPLATIN IN CERVICAL CANCER PATIENTS WITH PELVIC LYMPH NODE METASTASIS.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Nagarjun Ballari
Designation	Junior Resident
Affiliation	PGIMER
Address	house number 135, sector 11 a, Chandigarh Department of Radiotherapy, cobalt block, Nehru Hospital,PGIMER, Chandigarh, 160012 Chandigarh CHANDIGARH 160011 India
Phone	9781882345
Fax
Email	nagarjunballari@gmail.com

Details of Contact Person
Scientific Query

Name	Bhavana rai
Designation	Professor
Affiliation	PGIMER
Address	Department of Radiotherapy, cobalt block, Nehru Hospital,PGIMER, Chandigarh, 160012 Chandigarh CHANDIGARH 160011 India
Phone	7087008391
Fax
Email	Bhavana1035@gmail.com

Details of Contact Person
Public Query

Name	Dr Nagarjun Ballari
Designation	Junior Resident
Affiliation	PGIMER
Address	house number 135, sector 11 a, Chandigarh Department of Radiotherapy, cobalt block, Nehru Hospital,PGIMER, Chandigarh, 160012 CHANDIGARH 160011 India
Phone	9781882345
Fax
Email	nagarjunballari@gmail.com

Source of Monetary or Material Support

none

Primary Sponsor

Name	PGIMER
Address	Post graduate institute of medical education and research, chandigarh,160012
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Nagarjun Ballari	PGIMER CHANDIGARH	PGIMER CHANDIGARH Chandigarh CHANDIGARH	9781882345 nagarjunballari@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	carcinoma cervix,

Intervention / Comparator Agent

Type

Name

Details

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Female
Details	1. Previously untreated, biopsy proven squamous cell carcinoma of cervix stage IB2-IIIB 2. Para aortic nodes negative and pelvic lymph node positive on FDG PET scans 3. Karnofsky performance scale > 70 (annexure-VII) 4. Pre treatment parameters :- a) Hemoglobin>10gm/dl b) TLC >4000/mm3 c) Platelets > 100000/mm3 d) Blood urea < 40 mg/dl e) Serum creatinine < 1.2mg/dl f) Normal Chest X-ray 5. Patients willing to give informed consent and agreeing for follow up

ExclusionCriteria

Details

1. All post operative cases
2. History of prior pelvic radiotherapy
3. Patients having any uncontrolled co morbid conditions

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
1. To assess acute toxicity of extended field intensity modulated radiotherapy concurrent chemotherapy in patients of cervical cancer with PET positive pelvic lymph nodes.	WEEKLY ASSESSMENT OF ACUTE TOXICITY DURING TREATMENT ASSESSMENT OF TOXICITY AFTER 6 WEEKS OF COMPLETE TREATMENT

Secondary Outcome

Outcome	TimePoints
late toxicity of treatment	1 year post treatment

Target Sample Size

Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15"

Phase of Trial

Phase 2

Date of First Enrollment (India)

15/09/2014

Date of Study Completion (India)

31/12/2017

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)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

NONE

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Cervical cancer is the second leading malignancy in Indian women. Majority of the cervical cancer cases present to us in locally advanced stage. Concurrent chemo radiation is the treatment of choice for these patients. However many treatment failures occur in the para aortic region. It is hypothesised that these failures are due to the pre existing subclinical micrometastatic disease in the para aortic lypmh nodes which are not addressed by local pelvic RT ot concurrent chemotherapy given as a standard treatment.

The challenge is in identifying these patients who harbor micrometastatic disease in para aortic region. Lymph node dissection is the standard investigation that can identify these patients. However it is not possible in all patients because of the morbidity of the surgical staging procedure when cobined with post operative radiotherapt and also due to logistics.

PET-CT has been shown to identify these patients. more so PET-CT has shown that patient with pelvic lymph node metastases have greater risk of having para aorrtic lymph node metastases.

Our study is aimed at dientifyying these subset of patients with the help of PET-CT ,and then treating them with extended field radiotherapy plus concurrent cisplatin in contrast to the standard Pelvic RT+ CCT.

Acute toxiciy is a major concern with such a large field. Acute toxicity reported during treatment and 6 weeks after completion will be used as a surrogate to assess the feasibility of this approach in our setup.