Chemoradiotherapy in patients with localised lung cancer

Trans Tasman Radiation Oncology Group (TROG) 03.07 - A randomised phase II study of two regimens of palliative chemoradiation therapy (Vinorelbine and cisplatin OR Gemcitabine) in the management of locally advanced and metastatic non-small lung cancer to improve response rate.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000519550

Acronym

TROG 03.07

Enrollment

Registered

2003-12-22

Start date

2003-12-04

Completion date

2007-07-14

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

Brief summary

Using radiotherapy and chemotherapy together works better in locally advanced lung cancer than using either treatment alone but has worse side effects. Many people are not fit enough to have these treatments given in the standard way. This study will test the feasibility and activity of two gentler ways of combining them.

Interventions

Arm A: External beam radiation, 40Gy in 20 fractions/5 times per week plus Vinorelbine, IV, 25mg/m square, days 1, 8, 22 and Cisplatin 20mg/m cubed, IV, weekly. Subjects receive this treatment over 1 month (4 weeks).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologically or cytologically proven non-small cell lung cancer.- Planned high dose palliative radiation therapy for locoregional control. Examples include patients with: a) Stage I – IIIB disease with: -disease technically unsuitable for radical therapy, or -weight loss in excess of 10%, or -concurrent medical illness b)Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a Flurodeoxyglucose-Positron Emission Tomography (FDG-PET) only solitary metastasis.- All potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.- No prior radiotherapy or chemotherapy for non-small cell lung cancer. - European Cooperative Ooncology Group performance status 0, 1.- Adequate hepatic, bone marrow and renal function.- If patient is female of child bearing potential, she must not be pregnant or lactating. Males and females of reproductive potential must practise adequate contraception.- Written informed consent.

Exclusion criteria

Patient unable to receive all therapy as an outpatient.- Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.- 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