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Study on Early Stage Bulky Cervical Cancers

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ClinicalTrials.gov Identifier: NCT01917695
Recruitment Status : Unknown
Verified August 2015 by Rajkumar Kottayasamy Seenivasagam, Government Royapettah Hospital.
Recruitment status was:  Recruiting
First Posted : August 7, 2013
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Rajkumar Kottayasamy Seenivasagam, Government Royapettah Hospital

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.

Condition or disease Intervention/treatment Phase
Carcinoma Cervix Drug: Chemotherapy Radiation: External Beam Radiotherapy Radiation: Brachytherapy Procedure: Radical Hysterectomy Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2013
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: Concurrent Radical Chemoradiation
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
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

Radiation: Brachytherapy
Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.

Experimental: Neoadjuvant Chemoradiation + 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
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

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

Experimental: Neoadjuvant Chemotherapy + 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
Drug: Chemotherapy
cisplatin 75 mg/m2 Paclitaxel 175 mg/m2

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




Primary Outcome Measures :
  1. Overall and Disease free Survival [ Time Frame: 3 year ]
  2. Overall and Disease free Survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Acute Adverse reactions and complications [ Time Frame: Less than 10 weeks ]
  2. SubAcute Adverse reactions and complications [ Time Frame: 10 weeks - 6 months ]
  3. Chronic Adverse reactions and complications [ Time Frame: 6 months to 5 years ]

Other Outcome Measures:
  1. Quality of Life [ Time Frame: 3,5 years ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917695


Contacts
Contact: Rajaraman Ramamurthy, MS MCh +919444046168 rajaanu1@rediffmail.com
Contact: Subbiah Shanmugam, Ms MCh +919360206030 subbiah_doctor@yahoo.co.uk

Locations
India
Government Royapettah Hospital Recruiting
Chennai, Tamil Nadu, India, 600014IndiaNaduI6
Contact: Rajaraman Ramamurthy, MS MCh    +919444046168    rajaanu1@rediffmail.com   
Contact: Subbiah Shanmugam, MS MCh    +919360206030    subbiah_doctor@yahoo.co.uk   
Principal Investigator: Rajaraman Ramamurthy, MS MCh         
Sub-Investigator: Subbiah Shanmugam, MS MCh         
Sponsors and Collaborators
Rajkumar Kottayasamy Seenivasagam
Investigators
Study Chair: Rajaraman Ramamurthy, MS MCh centre for oncology, Government Royapettah Hospital

Responsible Party: Rajkumar Kottayasamy Seenivasagam, MCh Surgical Oncology trainee, Government Royapettah Hospital
ClinicalTrials.gov Identifier: NCT01917695     History of Changes
Other Study ID Numbers: GRHCO-01
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Rajkumar Kottayasamy Seenivasagam, Government Royapettah Hospital:
Bulky cervical cancers
Neoadjuvant Chemotherapy
Neoadjuvant Chemoradiotherapy

Additional relevant MeSH terms:
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action