ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612001211853

Ethics application status

Yes

Date submitted

2/11/2012

Date registered

15/11/2012

Date last updated

Type of registration

Retrospectively registered

Titles & IDs

Public title

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)

Scientific title

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

P_LUNG GP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Non Small Cell Lung Cancer (NSCLC)

Condition category

Condition code

Cancer

Lung - Non small cell

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Chemotherapy + High Dose palliative Radiation Therapy (C-HDPRT)
1. Radiation Therapy; 40Gy/20f (2Gy/f, 4-5f/week)
2. Chemotherapy; IV cisplatin 20mg/m2 (days 1, 8, 15, 22 of RT) plus IV vinorelbine 25mg/m2 (days 1, 8 and 22 of RT).

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: drugs

Comparator / control treatment

High Dose palliative Radiation Therapy (HDPRT) alone

1. Radiation Therapy; 36Gy/12f (3Gy/f, 4-5f/week)

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome of this trial is to compare high dose palliative radiotherapy (HDPRT) versus concurrent chemotherapy and HDPRT (C-HDPRT), with respect to the relief of dyspnoea, cough, haemoptysis and chest pain as assessed by change in total symptom burden from baseline to six weeks after the completion of treatment, and the response for each component symptom separately (dyspnoea, cough, haemoptysis, chest pain)

Timepoint [1]

Toxicity assesments (NCIC CTCAE v 3.0) and physical exams performed at pre registration, pre treatemnt, during treatment, end of treatment, 2 wks post treatment, 6 weeks post treatment.

Secondary outcome [1]

Comparison of the two regimens in terms of dysphagia during treatment by clinical examination and patient reported outcomes.

Timepoint [1]

Pre registration, pre treatment, during treatment, end of treatment, 2 wks post treatment, 6 weeks post treatment, 3 months post treatment, 6 months post treatment and then 3 monthly until progression.

Secondary outcome [2]

Comparison of the two regimens in terms of thoracic symptom response rate by clinical examination and patient reported outcomes

Timepoint [2]

Secondary outcome [3]

Comparison of the two regimens in terms of duration of thoracic symptom response by clinical examination and patient reported outcomes.

Timepoint [3]

Secondary outcome [4]

Comparison of the two regimens in terms of Quality of Life (QOL) Questionniares (QLQ-C30, QLQ-LC13) and Physician rated Spitzer index

Timepoint [4]

Secondary outcome [5]

Comparison of the two regimens in terms of Toxicity (NCIC CTCAE v 3.0)

Timepoint [5]

Toxicity assesments (NCIC CTCAE v 3.0) at Pre treatment, during treatment, end of treatment, 2 wks post treatment, 6 weeks post treatment, 3 months post treatment, 6 months post treatment and then 3 monthly until progression.

Secondary outcome [6]

Comparison of the two regimens in terms of Progression-free survival by physical exams and imaging.

Timepoint [6]

Physical Examinations; pre registration, pre treatment, during treatment, end of treatment, 2 wks post treatment, 6 weeks post treatment, 3 months post treatment, 6 months post treatment and then 3 monthly until progression. Medical Imaging (CT scans +/-PET); Pre regisatration, 6 weeks post treatment, 3 months post treatment and then 3 monthly until progression (if clinically indicated).

Secondary outcome [7]

Overall survival (clincal assessments)

Timepoint [7]

Pre treatemnt, during treatment, end of treatment, 2 wks post treatment, 6 weeks post treatment, 3 months post treatment, 6 months post treatment and then 3 monthly until progression.

Eligibility

Key inclusion criteria

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 </= 1.0 x upper limit of normal (ULN), AST/ALT </= 2.0 x ULN, ALP </= 2.5 x ULN.

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.

Minimum age

18 Years

Maximum age

100 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

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

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Patients will be randomised in the ratio of 1:1 between the two arms, HDPRT and C-HDPRT. Allocation is determined by central randomisation by computer and allocation concealment is used.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Allocation to treatment arms will be stratified by tumour stage (III, IV), tumour histology (adenocarcinoma, SCC, other), major chest symptoms (presence or absence of each of dyspnoea, cough, haemoptysis and chest pain) and treating Institution, using the minimisation technique (with a random component).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 3

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Open to recruitment

Date of first participant enrolment

Anticipated

1/11/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

130

Accrual to date

Final

Recruitment outside Australia

Country [1]

State/province [1]

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cancer Australia

Address [1]

Locked Bag 3 Strawberry Hills NSW, 2012

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

Trans Tasman Radiation Oncology Group

Address

Central Operations Office
Department of Radiation Oncology
Calvary Mater Newcastle
Locked Bag 7
Hunter Region Mail Centre
NSW 2310

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Other Collaborative groups

Name [1]

Australasian Lung Trials Group

Address [1]

ALTG Group Manager The Australian Lung Foundation 44 Brookes Street Bowen Hills, QLD 4006

Country [1]

Australia

Ethics approval

Ethics application status

Yes

Ethics committee name [1]

Metro South Hospital and Health Service Human Research Ethics Committee (EC00167)

Ethics committee address [1]

Ipswich Road
Woolloongabba 
Qld 4102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/05/2012

Approval date [1]

28/06/2012

Ethics approval number [1]

HREC/12/QPAH/172

Summary

Brief summary

Lung cancer is the fifth most common cancer in Australia and the leading cause of cancer deaths. The majority of lung cancers are of the Non Small Cell Lung Cancer (NSCLC) histological type and most patients present with inoperable Stage III or IV disease.

The population to be studied in this trial are patients with inoperable NSCLC who have a good PS but locally advanced or limited metastatic disease for whom radical CT-RT (=60Gy) is not feasible either due to tumour extent or patient factors. In these patients, the aim of therapy is to achieve symptom control and maintain Quality of Life (QOL). However, the optimal treatment regimen for this group is uncertain. 
 
Hypothesis-
The hypothesis is that the addition of chemotherapy to high dose palliative radiotherapy in these patients will maximises intrathoracic symptom palliation (both the extent of improvement and its duration), which will lead to an improvement in QOL, and is associated with acceptable toxicity, compared with high dose palliative radiotherapy alone.

Objectives-
The Primary objective is to compare, in this group of patients, high dose palliative radiotherapy (HDPRT) versus concurrent chemotherapy and HDPRT (C-HDPRT), with respect to 
 - The relief of dyspnoea, cough, haemoptysis and chest pain as assessed by change in total symptom burden from baseline to six weeks after the completion of treatment.  
 - Response for each component symptom separately (dyspnoea, cough, haemoptysis, chest pain)

The secondary objectives are to compare the two regimens in terms of; Dysphagia during treatment, Thoracic symptom response rate, Duration of thoracic symptom response , QOL, Toxicity, Progression-free survival and Overall survival. 

The exploratory/tertiary objectives are; 
 - to determine how much improvement in QoL and symptom palliation would be necessary to make the inconvenience due to the longer duration of radiotherapy of C-HDPRT worthwhile, relative to HDPRT. This objective will be addressed in the Patient Preferences Substudy.
 - Analyse serum protein glycosylation changes and exosomes to identify potential biomarkers of disease response and progression
 - Prospectively collect and bank tumour tissue and blood samples from this cohort of patients for future evaluation of potential biological markers 

End Points-
Primary - 
 - Change from baseline at 6 weeks after treatment in the Intrathoracic Symptom Burden Index 
 - Change from baseline at 6 weeks after treatment in each of the component symptoms, dyspnoea, cough, haemoptysis and chest pain.
Secondary -
 - Profile of change from baseline of Intrathoracic Symptom Burden Index, and of component symptoms, by time (6 weeks, 3, 6, 12, 24 months)
 - Thoracic symptom response rate and response duration
 - Physician’s rating of cough, dyspnoea, haemoptysis and chest pain, summed into a symptom index and performance status (Karnofsky) and QOL (Spitzer)
 - Toxicity measured by NCIC CAE v 3.0
 - Tumour response, Progression-free survival and Overall survival

Trial Design-
This is a multi-centre, two-arm, randomised (1:1) Phase III trial to compare high dose palliative radiotherapy (HDPRT) versus concurrent chemotherapy and HDPRT (C-HDPRT) in patients with inoperable NSCLC. 

1) ARM A (control arm): High dose palliative RT (HDPRT) alone (36Gy/12 fractions, 4-5 fractions/week) or 

2) ARM B (investigational arm): Chemotherapy + HDPRT (40Gy/20fractions, 4-5 fractions/week + IV cisplatin 20mg/m2 days 1, 8, 15, 22 + IV vinorelbine 25mg/m2 days1, 8, 22). (C + HDPRT)

All eligible patients will be stratified according to tumour stage, histology, major chest symptoms and treating institution. 

The total participant accrual for this trial will be 130. The accrual period is expected to be 41 months and total study duration 55 months.

Trial website

www.trog.com.au (http://www.trog.com.au/Default.aspx?tabid=71)

Trial related presentations / publications

-

Public notes

Contacts

Principal investigator

Contact person for public queries

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically