CHISEL
ACTRN12610000479000
Treatment
Phase 3
Government body,Cancer Australia
Ms Marijana Venvski
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 .... Read more
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 .... Read more
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.
No
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 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.
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 .... Read more
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) criteriaTimepoint: At baseline, weekly during radiotherapy treatment, 3 monthly (post radiotherapy) for 2 years, then 6 monthly until 2 years following the end of treatment.