Data

TROG 09.02 CHISEL A randomised phase III trial of highly conformal hypofractionated image guided (“Stereotactic”) radiotherapy (HypoRT) versus conventionally fractionated radiotherapy (ConRT) for inoperable early stage I non small cell lung cancer.

Trans Tasman Radiation Oncology Group (TROG Cancer Research)

Dataset description

Dataset Contains: time to local failure; overall survival; lung cancer specific survival; toxicity; quality of life (EORTC QLQ C30 and LC 13, State Trait and Anxiety Inventory (STAI), Distress Thermometer and Cancer Worry Scale); Imaging data (CT); Approx time of data collection 2009-2017; Radiotherapy Quality Assurance 100 RTQA imaging datasets; 39 benchmarking datasets; RT Plan, RT delivery and imaging documentation, LRF and eligibility (DICOM format)
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Subjects

Radiation Therapy |

Source Study

Funding

Government body,Cancer Australia

Scientific enquiries

Ms Marijana Venvski

Brief Summary

The purpose of this study is to investigate whether radiotherapy given as three large doses over a period of two weeks (hypofractionated radiotherapy) is more effective than standard radiotherapy for patients with non-small cell lung cancer that has not spread beyond the lung. Who is it for? You may be eligible to join this study if you aged 18 years or above and have a confirmed diagnosis of non-small cell lung cancer within 6 weeks of study enrolment. Study details Participants in this study w ....
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Key Inclusion Criteria

Patients may be included in the trial only if they meet all of the following criteria: · Histologically or cytologically confirmed non-small cell lung cancer diagnosed within 6 weeks prior to randomisation. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma, large cell neuroendocrine, and non-small cell carcinoma not otherwise specified. · Aged 18 years or older · Disease stage T1N0 or T2aN0 (Internati ....
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Key Exclusion Criteria

Patients who fulfil any of the following criteria are not eligible for admission to the trial: · Centrally located tumours (< 1.0 cm from mediastinum or < 2.0 cm from bifurcation of lobar bronchus). · Tumours within 1.0 cm of the chest wall. · Prior chemotherapy. · Previous radiotherapy to the area to be treated. · Women who are pregnant or lactating. · Patient with multiple synchronous primary tumours requiring radiotherapy.

Can healthy volunteers participate?

No

 

Population

Sample Size    101

Min. age    18 Years

Max. age    0 No limit

Sex    Both males and females

Condition category    Stage I non small cell lung cancer

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs , Treatment: Other

Arm 1: Investigational. Treatment: Other - Hypofractionated radiotherapy (HypoRT). Highly conformal hypofractionated radiotherapy to a total dose of 54Gy in 3 fractions, 18 Gy each, delivered weekly on days 0, 7 and 14 with a maximum deviation of +/- 2 days from the specified time allowed.

Comparison

Control group Active

Arm 2: Standard of Care. Treatment: other - Conventionally fractionated radiotherapy (ConRT). Standard radiotherapy to a total dose of 60-66Gy delivered in daily 2Gy in 30-33 fractions over 6-6.5 weeks. Treatment: drugs - Carboplatin. If chemotherapy is the institutional practice for this group of patients, concurrent carboplatin (Area Under the Curve (AUC)=2/wk) will be given weekly with paclitaxel for 6 weeks. Treatment: drugs - Paclitaxel. If chemotherapy is the institutional practice for thi ....
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Outcomes

Outcome: Time to Local Failure. Measured from date of randomisation to time of local failure. Local failure will be measured via clinical assessment (physical examination and imaging where indicated) and measurement of local disease using the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
Timepoint: At baseline, weekly during radiotherapy treatment, 3 monthly (post radiotherapy) for 2 years, then 6 monthly until 2 years following the end of treatment.

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au