Study on Early Stage Bulky Cervical Cancers

Phase 3

• Conditions: Carcinoma Cervix
• Interventions: Drug: Chemotherapy; Radiation: External Beam Radiotherapy; Procedure: Radical Hysterectomy; Radiation: Brachytherapy

• Registration Number: NCT01917695
• Lead Sponsor: Rajkumar Kottayasamy Seenivasagam

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

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-08-03
• Study First Submitted QC: 2013-08-05
• Study First Posted: 2013-08-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Chemoradiation + Radical Hysterectomy	Chemotherapy	Paclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks
Neoadjuvant Chemoradiation + Radical Hysterectomy	Radical Hysterectomy	Paclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks
Concurrent Radical Chemoradiation	Brachytherapy	Paclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks
Concurrent Radical Chemoradiation	Chemotherapy	Paclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks
Concurrent Radical Chemoradiation	External Beam Radiotherapy	Paclitaxel(175 mg/sq.m) + Cisplatin (75 mg/sq.m) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT + Brachytherapy (7Gy HDR x 3 doses) All to be completed within 8-10 weeks
Neoadjuvant Chemoradiation + Radical Hysterectomy	External Beam Radiotherapy	Paclitaxel(175 mg/m2) + Cisplatin(75 mg/m2) chemotherapy - 2 cycles of 3 weekly cycle Concurrent Radiotherapy - 50 Gy EBRT - completed within 5 weeks Radical Hysterectomy - 3 weeks after completion of RT All to be completed within 8-10 weeks
Neoadjuvant Chemotherapy + Radical Hysterectomy	Chemotherapy	Paclitaxel(175 mg/m2) + Cisplatin (75 mg/m2) chemotherapy - 3 cycles of 3 weekly cycle Radical Hysterectomy - 3 weeks after completion of chemotherapy All to be completed within 8-10 weeks
Neoadjuvant Chemotherapy + Radical Hysterectomy	Radical Hysterectomy	Paclitaxel(175 mg/m2) + Cisplatin (75 mg/m2) chemotherapy - 3 cycles of 3 weekly cycle Radical Hysterectomy - 3 weeks after completion of chemotherapy All to be completed within 8-10 weeks

Primary Outcome Measures

Name	Time	Method
Overall and Disease free Survival	5 year

Secondary Outcome Measures

Name	Time	Method
Acute Adverse reactions and complications	Less than 10 weeks
Chronic Adverse reactions and complications	6 months to 5 years
SubAcute Adverse reactions and complications	10 weeks - 6 months

Trial Locations

Locations (1)

Government Royapettah Hospital; 🇮🇳 Chennai, Tamil Nadu, India