Study on Early Stage Bulky Cervical Cancers

Carcinoma Cervix Clinical Trial

Official title:

Randomised Phase III Clinical Trial on Concurent Chemoradiation vs. Neoadjuvant Chemoradiation and Surgery vs. Neoadjuvant Chemotherapy and Surgery in Early Stage Bulky Cervical Cancers (FIGO Stages IB2, IIA2 and IIB)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01917695
• Other study ID #: GRHCO-01
• Status: Recruiting
• Phase: Phase 3
• First received: August 3, 2013
• Last updated: August 11, 2015
• Start date: August 2013
• Est. completion date: August 2018

Study information

• Verified date: August 2015
• Source: Government Royapettah Hospital
• Contact: Rajaraman Ramamurthy, MS MCh
• Phone: +919444046168
• Email: rajaanu1[@]rediffmail.com
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to establish the role of neoadjuvant chemotherapy and chemo irradiation in carcinoma cervix and to compare its results with the concurrent chemo irradiation in terms of overall survival, disease free survival and quality of life.

Description:

Early stage bulky cancers of the cervix, (defined as FIGO Stages IB2, IIA2 and IIB) form a distinctive subset of "curable" cervical cancers with good 5 year survival rates with adequate treatment. Concurrent chemo radiation with or without salvage surgery is at present the standard of care for this group of cervical cancers. However, when pelvic recurrences occur, the morbidity of salvage surgery after radiotherapy, especially brachytherapy is often higher than the morbidity of salvage radiotherapy following radical surgery. The advantages of downsizing the disease without the use of brachytherapy are tempting and open a completely new philosophy in radical treatment for "curable" early stage bulky cancers of the cervix. This approach is appealing especially in developing countries where the load of cervical cancers is high and radiotherapy (brachytherapy) resources are scarce.

The results of two Phase II trials conducted at Govt. Royapettah Hospital, Chennai (Neoadjuvant Chemotherapy followed by Radical Hysterectomy: Cisplatin + 5FU vs. Cisplatin +Paclitaxel) and at Govt. General Hospital,Chennai (Neoadjuvant Chemoradiation with weekly cisplatin and 50 EBRT followed by radical Hysterectomy) and one retrospective study ( Preoperative 50 GY EBRT followed by Radical Hysterectomy) have shown similar response rates and acceptable toxicity profiles when compared to concurrent chemoradiation (EBRT + Brachytherapy+ Chemotherapy). Similar studies have been published elsewhere with similar results.

With this in mind we are planning to conduct a Phase III Randomised control trial comparing Neoadjuvant Chemotherapy + Radical Hysterectomy and Neoadjuvant Chemoradiation + Radical Hysterectomy with concurrent chemoradiation in this subset of cervical cancers

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).

2. Age 18-60 years

3. Karnofsky performance status of =70%; ECOG PS = 2

Exclusion Criteria:

1. Nonsquamous Histologies

2. Other systemic diseases, comorbidities precluding full participation in the study

3. Concomitant treatment with any experimental drug

4. Pregnant or nursing women

5. Previous or concomitant malignant diseases other than non-melanoma skin cancer

6. Previous radiation to the pelvis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma Cervix
• Uterine Cervical Neoplasms

Intervention

Drug:
• Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2

Radiation:
• External Beam Radiotherapy
50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
• Brachytherapy
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.

Procedure:
• Radical Hysterectomy
Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection

Locations

Country	Name	City	State
India	Government Royapettah Hospital	Chennai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Rajkumar Kottayasamy Seenivasagam

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life		3,5 years	No
Primary	Overall and Disease free Survival		3 year	No
Primary	Overall and Disease free Survival		5 year	No
Secondary	Acute Adverse reactions and complications		Less than 10 weeks	Yes
Secondary	SubAcute Adverse reactions and complications		10 weeks - 6 months	Yes
Secondary	Chronic Adverse reactions and complications		6 months to 5 years	Yes