A study to assess the effect of two chemotherapy drugs (paclitaxel and Cisplatin) along with radiation in treating cancer of the uterine cervix

Phase II study of Concurrent Chemoirradiation with weekly Paclitaxel and Cisplatin in the treatment of Carcinoma of the Cervix

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000029

Enrollment

Registered

2008-05-30

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

None listed

Interventions

Intervention1: Radiation Therapy, Paclitaxel, Cisplatinum: Radiation Therapy : External

50Gy in 25 Fractions , 5 Fractions per week over 5 weeks Brachytherapy

27 - 30Gy to Point A Control Intervention1: Not Applicable: Not Applicable

Eligibility

Inclusion criteria

Inclusion criteria: ? Women with previously untreated squamous cell carcinoma of cervix , stages IB2 ? III B ? Performance score ECOG 0, 1, 2

Exclusion criteria

Exclusion criteria: ? Previous treatment for carcinoma cervix ? Hepatic/renal dysfunction ? Cardiac co morbidities (active cardiac disease like MI in the last 6 months, uncontrolled arrhythmias, Left ventricular dysfunction, cardiac failure) ? Pre existing Peripheral neuropathy ? Age > 70 years and < 18 years ? Para aortic lymph node involvement ? Pregnant women ? Synchronous malignancies ? S. creatinine >1.4, Creatinine clearance <50 ? SGOT, SGPT and ALP > x 2.5 normal ? Hb<8.0g/dl, TC <3000/cmm, ANC <1000 /cmm, platelet count <1,00,000/cmm

Design outcomes

Primary

Measure	Time frame
To assess the early response of tumor and toxicity to concurrent chemoirradiation with Paclitaxel and Cisplatin assessed at the end of External Radiotherapy and at 6 weeks after completing treatment. Timepoint: At the end of Radiation and six weeks after completion Chemoradiation	—

Secondary

Measure	Time frame
To assess the survival rates and delayed toxicity of this regimenTimepoint: At the end of 2 years and 5 years	—

Countries

India

Contacts

Public ContactDr. P.N. Viswanathan

Christian Medical College, Vellore.

tomsamram@cmcvellore.ac.in0416 2283145

Outcome results