NCT01917695

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

5 years

First QC Date

August 3, 2013

Last Update Submit

August 11, 2015

Conditions

Carcinoma Cervix

Keywords

Bulky cervical cancersNeoadjuvant ChemotherapyNeoadjuvant Chemoradiotherapy

Outcome Measures

Primary Outcomes (2)

  • Overall and Disease free Survival

    3 year

  • Overall and Disease free Survival

    5 year

Secondary Outcomes (3)

  • Acute Adverse reactions and complications

    Less than 10 weeks

  • SubAcute Adverse reactions and complications

    10 weeks - 6 months

  • Chronic Adverse reactions and complications

    6 months to 5 years

Other Outcomes (1)

  • Quality of Life

    3,5 years

Study Arms (3)

Concurrent Radical Chemoradiation

ACTIVE COMPARATOR

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: ChemotherapyRadiation: External Beam RadiotherapyRadiation: Brachytherapy

Neoadjuvant Chemoradiation + Radical Hysterectomy

EXPERIMENTAL

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: ChemotherapyRadiation: External Beam RadiotherapyProcedure: Radical Hysterectomy

Neoadjuvant Chemotherapy + Radical Hysterectomy

EXPERIMENTAL

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: ChemotherapyProcedure: Radical Hysterectomy

Interventions

ChemotherapyDRUG

cisplatin 75 mg/m2 Paclitaxel 175 mg/m2

Concurrent Radical ChemoradiationNeoadjuvant Chemoradiation + Radical HysterectomyNeoadjuvant Chemotherapy + Radical Hysterectomy
External Beam RadiotherapyRADIATION

50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5

Concurrent Radical ChemoradiationNeoadjuvant Chemoradiation + Radical Hysterectomy
BrachytherapyRADIATION

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

Concurrent Radical Chemoradiation
Radical HysterectomyPROCEDURE

Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection

Neoadjuvant Chemoradiation + Radical HysterectomyNeoadjuvant Chemotherapy + Radical Hysterectomy

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with histologically confirmed bulky cervical Squamous cell carcinoma (FIGO stage IB2, II A2, IIB).
  • Age 18-60 years
  • Karnofsky performance status of ≥70%; ECOG PS ≤ 2

You may not qualify if:

  • Nonsquamous Histologies
  • Other systemic diseases, comorbidities precluding full participation in the study
  • Concomitant treatment with any experimental drug
  • Pregnant or nursing women
  • Previous or concomitant malignant diseases other than non-melanoma skin cancer
  • Previous radiation to the pelvis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Royapettah Hospital

Chennai, Tamil Nadu, 600014IndiaNaduI6, India

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug TherapyBrachytherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRadiotherapy

Study Officials

  • Rajaraman Ramamurthy, MS MCh

    centre for oncology, Government Royapettah Hospital

    STUDY CHAIR

Central Study Contacts

Rajaraman Ramamurthy, MS MCh

CONTACT

+919444046168rajaanu1@rediffmail.com

Subbiah Shanmugam, Ms MCh

CONTACT

+919360206030subbiah_doctor@yahoo.co.uk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MCh Surgical Oncology trainee

Study Record Dates

First Submitted

August 3, 2013

First Posted

August 7, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

IN(1)