NCT01593306

Brief Summary

The purpose of this study is to check whether addition of paclitaxel to cisplatin and radiation therapy will improve the outcome in locally advanced carcinoma cervix.

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
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

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

July 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

1.3 years

First QC Date

May 3, 2012

Last Update Submit

May 7, 2012

Conditions

Carcinoma Cervix

Outcome Measures

Primary Outcomes (1)

  • clinical response of the disease

    to compare clinically, the disease response and local control of combination chemotherapy with weekly cisplatin and paclitaxel with concurrent Radiotherapy Vs single agent cisplatin with concurrent Radiotherapy in locally advanced carcinoma cervix

    up to 1 year

Secondary Outcomes (1)

  • number of patients with adverse events

    during treatment, 14 weeks

Study Arms (2)

cisplatin and paclitaxel with concurrent radiotherapy

EXPERIMENTAL

weekly cisplatin at 30mg/m2 and paclitaxel at 50mg/m2 are given with concurrent radiotherapy at 2Gy per fraction at 5 fractions per week for 5 weeks followed by either low dose rate (LDR) Intracavitary (I/C) Brachytherapy or supplement Chemoradiotherapy (CRT); if not fit for I/C Brachytherapy

Drug: Paclitaxel, Cisplatin

cisplatin with concurrent radiotherapy

ACTIVE COMPARATOR

weekly cisplatin @ 40mg/m2 is given along with concurrent radiotherapy at 2Gy per fraction with 5 fractions per week for 5 weeks followed by LDR I/C brachytherapy or supplement CRT; if not fit for I/C Brachytherapy

Drug: Cisplatin

Interventions

Paclitaxel, CisplatinDRUG

intravenous paclitaxel infusion at 50mg/m2/week and cisplatin at 30mg/m2/week for 5 weeks. if supplement Chemo Radiotherapy is required then similar dose per week for 2 more weeks.

cisplatin and paclitaxel with concurrent radiotherapy
CisplatinDRUG

intravenous infusion of cisplatin 40mg/m2/week for 5 weeks. if I/C Brachytherapy is not feasible then supplement CRT given with similar dose of cisplatin for 2 more cycles.

cisplatin with concurrent radiotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically proven carcinoma cervix
  • age 18 years to 65 years
  • stage IIA, IIB, IIIA \& IIIB according to FIGO 2009

You may not qualify if:

  • age \> 65 years and \< 18 years
  • stage IA, IB, IVA \& IVB
  • Histology other than squamous cell, adenocarcinoma or adenosquamous carcinoma
  • history of prior pelvic surgery for cancer, prior pelvic radiotherapy or prior chemotherapy.
  • deranged renal function test and liver function test
  • KPS \>= 60
  • distant metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indira Gandhi Medical College

Shimla, Himachal Pradesh, 171001, India

RECRUITING

Related Publications (1)

  • Thakur P, Seam R, Gupta M, Gupta M. Prospective randomized study comparing concomitant chemoradiotherapy using weekly cisplatin & paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix. Ann Transl Med. 2016 Feb;4(3):48. doi: 10.3978/j.issn.2305-5839.2015.11.19.

    PMID: 26904570DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

TP protocolCisplatin

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)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Pragyat Thakur, MBBS

    Indira Gandhi Medical College, Shimla

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pragyat Thakur, MBBS

CONTACT

919418029244pragyat28rpgmc@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident, department of radiotherapy, Principal Investigator

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 8, 2012

Study Start

July 1, 2011

Primary Completion

October 1, 2012

Study Completion

February 1, 2013

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

IN(1)