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Clinical Trials/CTRI/2017/08/009265
CTRI/2017/08/009265
Recruiting
Phase 3

A Phase III randomized clinical trial to study the radiosensitizing effect of Nelfinavir in Advanced Carcinoma of Cervix. - NELCER

Tata Memorial Centre and Varian International0 sites0 target enrollmentTBD
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ConditionsHealth Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
Sponsor
Tata Memorial Centre and Varian International
Status
Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Tata Memorial Centre and Varian International

Eligibility Criteria

Inclusion Criteria

  • •1\.ECOG 0\-2\.
  • •2\.FIGO 2018 Stage IIIA (TNM stage T3a N0 M0\)
  • •FIGO 2018 Stage IIIB (TNM stage T3b N0 M0\)
  • •FIGO 2018 Stage IIIC (TNM stage Any T N1 M0\)
  • •3\.No previous irradiation to the pelvis or chemo therapy
  • •4\.Ability to tolerate full course of pelvic radiotherapy and brachytherapy
  • •5\.Adequate bone marrow, liver, and kidney function defined as neutrophil count ââ?°Â¥ 1500, platelet count ââ?°Â¥ 100,000, total bilirubin \< 1\.5 x upper limit of normal (ULN), AST and ALT ââ?°Â¤ 2\.5 x ULN, and creatinine \< 1\.5 upper limit of normal OR Creatinine clearance \> 60 mL/min/1\.73 m2
  • •6\.No recent ( \< 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
  • •7\.Ability to understand and the willingness to sign an informed consent document.
  • •8\.Should be willing to undergo extra biopsy and blood collection for pharmacokinetic studies.

Exclusion Criteria

  • •1\.Patients with newly diagnosed diabetes. uncontrolled DM that is patients with Hb1c of greater than 6\.5% of FBS value or BFS greater than or equal to 126mg/dL respectively on primary evaluation
  • •2\.Patients on any drugs which has pharmacological interaction with nelfinavir:
  • •\-Terfenadine, cisapride, sildenafil, lovastatin or simvastatin and medication that are metabolized by the CYP3A4 isoenzyme.
  • •\-Antiarrhythmics (amiodarone, quinidine).
  • •\-Neuroleptics (pimozide).
  • •\-Sedative/Hypnotic agents (midazolam, triazolam).
  • •\-Ergot derivatives.
  • •\-HMG\-CoA reductase inhibitors (atorvastatin).
  • •\-Rifampicin, Rifabutin.
  • •\-Felodipine, Nifedipine.

Outcomes

Primary Outcomes

Not specified

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