CTRI Number |
CTRI/2017/12/010726 [Registered on: 01/12/2017] Trial Registered Prospectively |
Last Modified On: |
21/11/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Radiation Therapy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Gefitinib in cervical cancer |
Scientific Title of Study
|
A Prospective randomized open label study to evaluate the response rate and toxicity of Gefitinib in the treatment of carcinoma cervix patients on chemoradiotherapy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Mukesh S |
Designation |
Assistant professor |
Affiliation |
Mysore medical college and research institute |
Address |
Department of Radiotherapy,
KR hospital. Irwin road
Mysore
Mysore KARNATAKA 570001 India |
Phone |
919886873788 |
Fax |
|
Email |
dal_muk1@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Mukesh S |
Designation |
Assistant professor |
Affiliation |
Mysore medical college and research institute |
Address |
Department of Radiotherapy,
KR hospital. Irwin road
Mysore
Mysore KARNATAKA 570001 India |
Phone |
919886873788 |
Fax |
|
Email |
dal_muk1@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mukesh S |
Designation |
Assistant professor |
Affiliation |
Mysore medical college and research institute |
Address |
Department of Radiotherapy,
KR hospital. Irwin road
Mysore
Mysore KARNATAKA 570001 India |
Phone |
919886873788 |
Fax |
|
Email |
dal_muk1@hotmail.com |
|
Source of Monetary or Material Support
|
Mysore medical college and research institute.
Irwin road, near railway station.
Mysore 570001
Karnataka, India |
|
Primary Sponsor
|
Name |
Mysore medical college ad research institute |
Address |
Department of Radiotherapy,
KR hospital, Irwin road
Mysore 570001 |
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 |
Dr Sowmya MS |
Mysore medical collehe and research institute |
Department of Pharmacology
KR hospital, Irwin road
Mysore 570001 Mysore KARNATAKA |
917204907599
sowmyamims@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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Cervical cancer stage II to III, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
cisplatin and radiation |
concurrent chemoradiation. The dose of radiation is 50Gy/25 fraction, along with cisplatin of 40mg/m2 weekly for 6 cycles.This is followed by HDR Brachytherapy 3 fractions. |
Intervention |
Tablet Gefitinib 250 mg given orally daily through out the course of external radiation. |
concurrent chemoradiation. The dose of radiation is 50Gy/25 fraction, along with cisplatin of 40mg/m2 weekly for 6 cycles.This is followed by HDR Brachytherapy 3 fractions. along with this tablet gefitinib 250 mg daily through out external radiation treatment. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Female |
Details |
1. FIGO stage II to III cervical cancer.
2. Histopathologically proven cervical cancer.
3. Serum creatinine < 1.4mg/dl.
|
|
ExclusionCriteria |
Details |
1. Pregnant and breast feeding patients.
2. Immunocompromised patients and with Human
immunodeficient virsu (HIV) infection.
3. Any allergy to Cisplatin and Gefitinib.
4. Prior surgery for cervical cancer. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the response rate with the addition of Gefitinib in cervical cancer patients receiving chemoradiation. |
at the end of 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To evaluate the toxicity during the treatment |
during the treatment and post treatment at 6 months |
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
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 3 |
Date of First Enrollment (India)
|
11/12/2017 |
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) |
Other (Terminated) |
Publication Details
|
1. Vizcaino AP, Moreno V, Bosch FX, et al. International trends in incidence of cervical cancer: II. Squamous-cell carcinoma. Int J Cancer. 2000;86:429-435.
2.Gaffney DK, Haslam D, Tsodikov A, et al. Epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) negatively affect overall survival in carcinoma of the cervix treated with radiotherapy. Int J RadiatOncolBiol Phys. 2003;56:922Y928.
3.Gonclaves DK, Fabbro M, Lhomme C, et al.A phase II trial to evaluate gefitinib as second or third line treatment in patients with recurring locoregionally advanced or metastatic cervical cancer. Gynaecol onco. 2008; 108: 42-46 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Carcinoma cervix is the second most common malignancy among women and is a major cause of morbidity and mortality worldwide, where it accounts for 15% of all new female cancers with an estimated 2.75 lakhs deaths. 80% of incidental cervical cancer cases and deaths occur in developing countries because of socioeconomic causes pattern of health care delivery and other social factors. It is usually diagnosed at advanced stages in >80% of women in developing countries. In the last few years many advancement is seen in medical management of locally advanced cervical cancer, which includes preventive vaccination, chemoradiation and neoadjuvant chemotherapy. Active reasearches are taking place in molecular characterisation of cervical cancer, by which we may get better outcomes with novel therapeutic targets. Many biological factors like EGFR, VEGF, Microvessel density, hypoxic mechanism and expression of cox 2 have been proposed as prognostic determinants of carcinoma cervix. Cervical cancer is staged according to International Federation Of Gynaecology And obstetrics (FIGO) guidelines, where early stage patients do not require adjuvant systemic treatment unless there are high risk factors for recurrence in surgical specimen. These cases are usually prescribed with adjuvant chemoradiation. Systemic chemotherapy is the treatment of choice for most advanced cases that comprise stage IVB as well as patient with recurrent or persistent disease amenable to curative treatment. EGFR is present in many normal tissues and expressed in variety of solid tumours including cervical cancer.3EGFR activates tyrosine kinase domain to regulate multiple function such as cell growth, differentiation, gene expression and development. High expression of EGFR is thought to be the main mechanism by which EGFR signalling is increased in cancer cells , activating EGFR mutations, increased coexpression of receptor ligands ( EGFR, TGF alpha, amphiregulin), gene amplification, decreased levels of phosphatase , heterodimerisation etc. In particular HPV protein has an important role in EGFR expression. The HPV E5 oncoprotein inhibits degradation of internalised EGFR, resulting in an increase in EGFR recycling and overexpression of EGFR. Expression of HPV E6 has been linked to increase in EGFR levels and changes in functional levels of HPV E6/E7 protein may alter the growth rate of cervical cancer cell lines by decreasing the stability of EGFR at post transcriptional level. Patients will be randomised into
two arms. Control arm will receive concurrent chemoradiation. The dose of
radiation is 50Gy/25 fraction, along with cisplatin of 40mg/m2 weekly for 6 cycles.This is followed by
HDR Brachytherapy 3 fractions. The experiment arm will receive same treatment
as above plus tab gefitinib 250mg starting one week prior to chemoradiation and
continued throughout external radiation. Patients will be assessed for toxicity
and graded .
|