A randomised pilot study to investigate the optimum timing of gemcitabine and concurrent radiation therapy after induction gemcitabine and carboplatin for locally advanced non-small cell lung cancer

A randomised pilot study assessing tumor response by investigating the optimum timing of gemcitabine and concurrent radiation therapy after induction gemcitabine and carboplatin for locally advanced non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000169640

Enrollment

Registered

2005-08-17

Start date

2003-10-07

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Interventions

A randomised trial consisting of arms A and B. Both arms commence induction chemotherapy Day 1 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 8 Gemcitabine 1000mg/m2 Day 22 Gemcitabine 1000mg/m2 + Carboplatin AUC 5 Day 29 Gemcitabine 1000mg/m2 with Concurrent treatment, radiation and Gemcitabine treatment. Arm A will receive External beam radiation, 30 Gy/15 fractions/5 per week with Gemcitabine 200mg weekly with fractions days 43, 50 & 57 given 5 or more hours prior to the radiation. Arm B

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Histologically or cytologically proven non-small cell lung cancer.-Planned moderate dose radiation therapy for locoregional control. -Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have solitary metastasis. If in the brain the metastasis must be operable-Patients must have measurable disease on imaging scans.

Exclusion criteria

History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.-Receiving treatment with another investigational agent.

Outcome results