Clinical trial NCT01917695: Study on Early Stage Bulky Cervical Cancers
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma Cervix
Keywords: Bulky cervical cancers
Neoadjuvant Chemotherapy
Neoadjuvant Chemoradiotherapy
Lead sponsor: Government Royapettah Hospital
Sponsor class: OTHER
First posted: 2013-08-07
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Overall and Disease free Survival
timeFrame: 3 year
measure: Overall and Disease free Survival
timeFrame: 5 year
Secondary outcomes:
measure: Acute Adverse reactions and complications
timeFrame: Less than 10 weeks
measure: SubAcute Adverse reactions and complications
timeFrame: 10 weeks - 6 months
measure: Chronic Adverse reactions and complications
timeFrame: 6 months to 5 years
Other outcomes:
measure: Quality of Life
timeFrame: 3,5 years
Locations:
city: Chennai
country: India
facility: Government Royapettah Hospital
state: Tamil Nadu
Study officials:
affiliation: centre for oncology, Government Royapettah Hospital
name: Rajaraman Ramamurthy, MS MCh
role: STUDY_CHAIR
References: