Nimorazole with chemoradiation in locally advanced carcinoma cervix

A Phase II trial of Nimorazole with chemoradiation as primary treatment for locally advanced cervical cancer compared to chemoradiation alone

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017477

Enrollment

196

Registered

2019-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Interventions

Intervention1: Nimorazole with cisplatin and radiation.: Nimorazole at a dose of 1200 mg/m2 daily with standard of care chemoradiation in cervical cancer. Cisplatin at weekly dose of 40 mg/m2 upto 5

Eligibility

Inclusion criteria

Inclusion criteria: 1. FIGO 2008 stage IB1 & node positive, IB2, IIB, IIIB disease. 2. Age 18 years or older 3. ECOG performance status 0 - 2 4. Histological diagnosis of squamous cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the cervix 5. Hb > 9 g/dL WBC >= 3.0 x 109/L and ANC >= 1.5 x 109/L Platelets >= 100 x 109/L 6. Bilirubin AST or ALT 7. Adequate renal function: creatinine = 60ml/min or >= 50 ml/min by EDTA creatinine clearance 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Any previous pelvic radiotherapy 2. Para-aortic nodal involvement above the level of the common iliac nodes or L3/L4 (if biopsy proven or >= 10 mm short axis diameter on CT) 3. FIGO STAGE IIIA disease 4. Patients assessed at presentation as requiring interstitial brachytherapy treatment 5. Patients with bilateral hydronephrosis unless at least one side has been stented and renal function fulfils the required inclusion criteria 6. Evidence of metastases 7. Diagnosis of Crohnâ??s disease or ulcerative colitis 8. Peripheral neuropathy > grade 2 (as per CTCAE) 9. Patients who have undergone a previous hysterectomy or will have a hysterectomy as part of their initial cervix cancer therapy 10. Patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years 11. Patients who are pregnant or lactating 12. Any contraindication to cisplatin or nimorazole 13. Serious uncontrolled medical condition 14. HIV positive

Design outcomes

Primary

Measure	Time frame
Disease-free survival rate (DFS) Loco-regional control rate (LRC)Timepoint: 18 months	—

Secondary

Measure	Time frame
Overall survival rate (OS) Acute toxicity rate Number of hospital admission daysTimepoint: 18 months	—

Countries

India

Contacts

Public ContactPrashanth Giridhar

All India institute of medical sciences

prashanth.jipmer@gmail.com8098281729

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026