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Evaluating the necessity of Extra Granulocyte Colony Stimulating Factor (GCSF) in patients already Getting Peg GCSF after chemotherapy.

Assessing the Need for Rescue Granulocyte Colony Stimulating Factor (GCSF) in patients receiving primary prophylaxis with Peg GCSF post Chemotherapy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/073887
Enrollment
125
Registered
2024-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: C00-D49- Neoplasms

Interventions

None listed

Sponsors

Amala Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients more than 18 years of age 2. Patients with a histopathological proven diagnosis of cancer for whom first-line chemotherapy is being planned 3. High-risk or Intermediate-risk patients with more than or equal to 1 high-risk feature, requiring PEGylated G-CSF as a part of their chemotherapeutic regime.

Exclusion criteria

Exclusion criteria: 1. Patients who are on treatment and have previously received chemotherapy or radiation in the past or present. 2. Leukemias (Acute lymphoid leukaemia, acute myeloid leukaemia, and chronic lymphoid leukaemia) will be excluded

Design outcomes

Primary

MeasureTime frame
Incidence of Febrile NeutropeniaTimepoint: 12 weeks

Secondary

MeasureTime frame
Outcome at first response assessmentTimepoint: 6 months;PEG GCSF toxicityTimepoint: 12 weeks

Countries

India

Contacts

Public ContactAsif Rahman K A

Amala Institute of Medical Sciences

drashphilsmog@gmail.com9003635373

Outcome results

None listed

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