NCT03256916CompletedPhase 3
Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Cervix
A Phase III Randomized Clinical Trial to Study the Radiosensitizing Effect of Nelfinavir in Locally Advanced Carcinoma of Uterine Cervix.
Source: ClinicalTrials.gov · Last updated 24 Feb 2026
Brief summary (registry, in English)
The primary aim of the trial is to study the impact of nelfinavir on 3 year disease free survival in patients with advanced carcinoma of cervix receiving standard chemoradiation (Cisplatin and Radiotherapy). There will be two study groups. One group will receive standard treatment (concurrent chemoradiation and brachytherapy) \& other group will receive nelfinavir 5-7 days prior to standard treatment (chemoradiation \& brachytherapy).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 348 (actual)
- First submitted
- 31 Jul 2017
- Start date
- 16 Jan 2018
- Primary completion date
- 28 May 2024
- Lead sponsor
- Tata Memorial Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT03256916
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 348
- From 16 Jan 2018 to the primary completion date, 28 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pts 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.
Other illness
- Active co existing malignancy.
- HIV positive patients will be excluded.
- History of psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Lab values
- Patients with newly diagnosed diabetes , uncontrolled DM (patient with HbA1c of \> 6.5% or FBS value or BSF\>=126 mg/dL respectively on primary evaluation)
- Patients with reduced creatinine clearance ( less than 50 ml/ min) or unilateral or bilateral hydronephrosis will be excluded.
Other
- Pregnant or lactating
- Patients with hemophilia.
Who the study is looking for
- ECOG 0 to 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)
- No previous irradiation to the pelvis or chemotherapy
- Age 18 years and above
- Ability to tolerate full course of pelvic radiotherapy and brachytherapy
- Adequate bone marrow, liver, and kidney function defined as neutrophil count ≥ 1500 platelet count ≥ 100,000, total bilirubin less than 1.5 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN, and creatinine less than 1.5 upper limit of normal or Creatinine clearance greater than 60 mL/min/1.73 m2
- No recent (less than 3 months) severe cardiac disease (arrhythmia, congestive heart failure, infarction)
- Ability to understand and the willingness to sign an informed consent document
- Should be willing to undergo extra biopsy and blood collection for pharmacokinetic studies
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tata Memorial Centre Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.