Low dose gemcitabine vs standard dose gemcitabine in advanced lung cancer

Phase III Study Evaluating Efficacy and Safety of low dose Gemcitabine compared to standard dose Gemcitabine with platinum in advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/02/003422

Enrollment

308

Registered

2013-02-22

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: null- Advanced non-small cell lung cancer

Interventions

Intervention1: LOW DOSE GEMCITABINE: GEMCITABINE AT 250 MG/M2 INFUSED OVER 6 HOURS ALONG WITH CARBOPLATIN. CYCLES WILL BE REPEATED EVERY 21 DAYS FOR A TOTAL OF 6 CYCLES Control Intervention1: STANDARD

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with stage IIIB or IV; histological/ cytological proven NSCLC. 2. Signed informed consent. 3. Chemonaive patients non small cell lung cancer 4. Stage IV disease and III B patients for palliative chemotherapy 5. PS 0 to 2

Exclusion criteria

Exclusion criteria: 1. Patients with SVCO, symptomatic brain metastasis 2. Patients with uncontrolled cardiac or neurological illness 3. Patients with deranged end organ functions â?? ANC 1.5xULN, Liver enzymes >5 x ULN, Bilirubin >1.5xULN 4. Patients with any other malignancy treated in the last 5 years

Design outcomes

Primary

Measure	Time frame
OVERALL SURVIVALTimepoint: 1 year	—

Secondary

Measure	Time frame
SIDE EFFECTS, PROGRESSION FREE SURVIVAL, RESPONSE RATESTimepoint: PROGRESSION FREE SURVIVAL AT 1 YEAR	—

Countries

India

Contacts

Public ContactDr Kumar Prabhash

Tata Memorial Hospital

kp_prabhash@rediffmail.com02224177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 17, 2026