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Clinical Trials/CTRI/2024/06/068698
CTRI/2024/06/068698Not yet recruitingPhase 4

A pilot study assessing the role of induction chemotherapy followed by chemo radiation in locally advanced cervical cancer in a tertiary care hospital in central rural India

Siddharth gupta memorial hospital1 site in 1 country50 target enrollmentStarted: June 15, 2024Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
progression free survival in FIGO stage III and IVa patient after giving NACT

Study Overview

Brief Summary

After approval from the Institutional Ethics Committee, A pilot study will be conducted in MEDICAL ONCOLOGY and RADIATION ONCOLOGY Department of SGMCH unit of  department of Acharya Vinoba Bhave rural Hospital (AVBRH), a tertiary care teaching hospital situated in the rural area of  Wardha District, Maharashtra, India.

At first contact with the patient, a detailed history and clinical evaluation of the patient shall be done. Clinical examination and a biopsy from the cervical lesion shall be taken and any previous treatment will be ascertained.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • •Age more than 18 year ECOG 0/1 Good renal, hepatic and CBC Women with biopsy proven squamous, adeno or adenosquamous carcinoma Stage III and IVA FIGO (2018).

Exclusion Criteria

  • •Patients with early stage cancer stage I and II metastaic disease at presentation autoimmune disease patient who not willing for study.

Outcomes

Primary Outcomes

progression free survival in FIGO stage III and IVa patient after giving NACT

Time Frame: progression free survival in FIGO stage IIIand IVa patient after giving NACT after 8week of completion of radiation

Secondary Outcomes

  • progression free survival(At baseline)
  • radiation side effect compliance and tolerabilty(baseline)

Investigators

Sponsor
Siddharth gupta memorial hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Kanchan Dasharthrao Devde

Datta Meghe Institute of higher education and research centre

Study Sites (1)

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