TROG 11.03 A Randomised Phase III Trial of High Dose Palliative Radiotherapy (HDPRT) Versus Concurrent Chemotherapy + HDPRT (C-HDPRT) in Patients with Good Performance Status, Locally Advanced/Small Volume Metastatic Non Small Cell Lung Cancer (NSCLC) Not Suitable for Radical Chemo-Radiotherapy (P_LUNG GP)
- Conditions
- on Small Cell Lung Cancer (NSCLC)Non Small Cell Lung Cancer (NSCLC)Cancer - Lung - Non small cell
- Registration Number
- ACTRN12612001211853
- Lead Sponsor
- Trans Tasman Radiation Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 130
1. Aged 18 years or older
2. ECOG PS 0-1,
3. Histological or cytological proven stage III or IV NSCLC of any subtype: Adenocarcinoma, Squamous Cell Carcinoma (SCC), NSCLC Not Otherwise Specified (NOS) or Other (including Large Cell Undifferentiated).
4. Symptoms due to intrathoracic disease (at least one of cough, dyspnoea, haemoptysis, chest pain),
5. Patients with Stage III NSCLC not suitable for radical chemo-radiotherapy (due to concurrent medical illness, weight loss > 10% or tumour volume too large for radical radiation fields (e.g. dose constraints for organs at risk cannot be met using radical radiation fields or at the discretion of the investigator) or patients with locally advanced thoracic disease and a FDG-PET detected solitary metastasis (small volume Stage IV disease), Not cerebral metastasis
6. Planned for HDPRT to achieve local control
7. Adequate organ function;
a) Bone marrow: Haemoglobin (Hb) >/= 100g/l, Absolute neutrophil count (ANC) >/= 1.5 , Platelet count >/= 100
b) Hepatic: Serum bilirubin
c) Renal: Creatinine Clearance >/= 55 ml/min
8. No prior therapy for NSCLC
9. Able to commence Radiotherapy no later than 6 weeks, but preferably within 4 weeks from the time of participant randomisation. It is preferred that RT be commenced on a Monday or Tuesday.
10. Has provided written informed consent to participate in this trial
11. Participants capable of childbearing are using adequate contraception
12. Available for follow-up for a minimum of 3 months.
1. Receiving treatment with another investigational agent
2. History of any other cancer (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 3 years.
3. Women who are pregnant or lactating
4. Previous radiotherapy to the area to be treated, at any time.
5. 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method