Non Small Cell Lung CancerPhase 3CHISELNCT01014130
Hypofractionated Radiotherapy (Stereotactic) Versus Conventional Radiotherapy for Inoperable Early Stage I Non-small Cell Lung Cancer (NSCLC)
A Phase 3 study testing Hypofractionated radiotherapy (HypoRT) and Conventionally Fractionated Radiotherapy (ConRT) in people with Non Small Cell Lung Cancer, run by Trans Tasman Radiation Oncology Group at 19 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Hypofractionated radiotherapy (HypoRT) and Conventionally Fractionated Radiotherapy (ConRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Dec 2009to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (UICC TNM stage, 7th Ed, 2009), based on FDG PET/CT performed within 4-6 weeks prior to randomisation. T stage should be based on tumour size alone (i.e. no atelectasis).
- An ECOG performance status score of 0 or 1.
- The tumour has a peripheral location, defined as at least 1 cm beyond the mediastinum and 2 cm beyond the bifurcation of the lobar bronchi.
- Tumour is assessed as inoperable either i) because of unfitness for surgery as determined by the lung multidisciplinary team including thoracic surgeons and respiratory physicians or ii) because the patient refuses surgery.
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- Female patients of childbearing potential and male patients must agree to use adequate contraception throughout the treatment phase of the study.
- If female and of childbearing potential, a negative pregnancy test was performed within 7 days prior to randomisation.
- Patient is expected to survive and be available for follow up for two years.
- Patient has provided written informed consent for participation in this trial prior to any protocol-specified procedures.
- Patient undergoing chemoradiation has satisfactory haematological and biochemical parameters as described below:
- ANC ≥ 1.5 x 109,
- Platelets ≥ 100 x 109/L, Hb ≥ 100g/L,
- Creatinine clearance ≥ 40mls/min (patients with calculated creatinine clearance ≥ 40mls/min and < 60mls/min must have this confirmed by nuclear medicine GFR scan),
- Bilirubin < 1.5 x ULN, and
- ALT or AST < 2x ULN.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
Australia16 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Peter Maccallum Cancer Centre
Bendigo, Victoria, 3952
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Canberra Hospital
Canberra, Australian Capital Territory, 2605
Austin Hospital
Heidelburg, Victoria, 3084
Royal Hobart Hospital
Hobart, Tasmania, 7000
Liverpool Hospital
Liverpool, New South Wales, 2170
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Peter MacCallum Cancer Centre - Box Hill
Melbourne, Victoria, 3128
Peter MacCallum Cancer Centre - Morrabbin
Melbourne, Victoria, 3165
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Calvary Mater Hosipital
Newcastle, New South Wales, 2298
Alfred Hospital
Prahran, Victoria, 3181
Prince of Wales Hospital
Randwick, New South Wales, 2031
Royal North Shore Hospital
Sydney, New South Wales, 2069
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
New Zealand3 sites
Canterbury District Health Board
Christchurch, 4710
Auckland Hospital
Epsom, Auckland, 1023
Midcentral District Health Board
Roslyn, Palmerston North, 4442
About this study
Official title: 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 (CHISEL)
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. Although surgery is the most effective treatment for early lung cancer, many patients are not fit enough for an operation. The alternative treatment to surgery is standard radiotherapy which is normally 'fractionated' that is, given as a number of small doses over a period of weeks. Experience has shown that many small treatments are safer than using a few large doses (hypofractionation) because there is less risk of damage to normal tissues.
Recent advances in technology have however resulted in greater accuracy and with it a reduction in the amount of normal tissue affected by the radiation, so the risks of hypo-fractionation damaging normal tissue are of less concern. Initial results obtained with hypo-fractionated radiotherapy for early stage non-small cell lung cancer indicate that it may be more effective in controlling the cancer. However, it has never been compared directly with standard fractionation in a randomised trial, so this study aims to determine if hypo-fractionation is more effective, results in longer life expectancy and if it is just as safe as standard fractionation.
Read the detailed description
This is a multicentre randomised phase III trial comparing hypo-fractionated ("stereotactic') radiotherapy with conventional radiotherapy with or without chemotherapy in patients with inoperable stage 1 peripherally located non-small cell lung cancer.
The accepted standard of care for stage 1 non-small cell lung cancer (NSCLC), that is, T1 or T2 tumors that have not metastasised to the regional lymph nodes, is surgical resection. However, many patients with lung cancer have significant cardiovascular and respiratory co morbidities which render them unfit for an operation. For these patients, the standard of care is radiotherapy - conventional fractionation (ConRT) which is administered as 20-30 fractions over a period of four to six weeks. This reduces the likelihood of long term damage to incidentally irradiated normal tissues compared with non-fractionated treatment. Local failure for this method, varies considerably between reports ranging from 6-70% with a median value of 40% using a current best practice for inoperable NSCLC dose of about 60 Gy. Concomitant chemotherapy in addition to CF improves local progression free survival by 16% at two years compared with radiotherapy alone.
Highly conformal hypo-fractionated image guided radiotherapy is an emerging technically complex method for precision irradiation of stage 1 NSCLC using doses with a higher biological effect than can be achieved with standard treatment techniques. Although rates of local control using hypo-fractionation appear greater, there are risks with serious late toxicity. However, there is recent evidence that 54-57Gy delivered in 3 fractions can be delivered safely with no excessive toxicity, provided the tumour has a peripheral location, the chest wall is not included in the high dose volume and the treatment plan is highly conformal. Although hypo-fractionation under the above conditions appears to be tolerable, and is associated with high levels of local control, the results of a small number of phase II trials cannot be regarded as sufficient evidence to recommend it as the standard of care for inoperable stage I NSCLC.
This randomised phase III trial tests whether highly conformal hypo-fractionated image guided radiotherapy for peripherally located inoperable T1 and T2a NSCLC using a dose of 54 Gy in three fractions results in superior control of disease at the primary site compared with standard care consisting of conventionally fractionated radiotherapy with or without concomitant chemotherapy.
Treatment summary: Investigational arm - radical radiotherapy to a total dose of 54 Gy in 3 fractions of 18 Gy each, delivered weekly on days 0, 7 and 14 with a maximum deviation of +/- 2 days from the specified time allowed. Conventional arm - radical radiotherapy to a total dose of 60-66 Gy in 30-33 daily 2 Gy fractions over 6 weeks, with or without chemotherapy consisting of weekly carboplatin at an AUC of 2 and paclitaxel 45 mg/m2.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Hypofractionated radiotherapy (HypoRT), Conventionally Fractionated Radiotherapy (ConRT)
- Keywords
- Non Small Cell Lung Cancer, Hypofractionated, Stereotactic Radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiotherapy (HypoRT)Radiation
Also called HypoRT, Radiotherapy, RT
Highly conformal hypofractionated radiotherapy to a total dose of 54 Gy given in 3 fractions of 18 Gy each, delivered weekly on days 0, 7 and 14 with a maximum deviation of +/- 2 days from the specified time allowed.
Conventionally Fractionated Radiotherapy (ConRT)Radiation
Also called ConRT, Radiotherapy, RT
Standard radiotherapy to a total dose of 60-66 Gy prescribed to an isodose covering the PTV. It will be delivered as 30-33 fractions over a period of six to six and a half weeks. If the use of chemotherapy is the institutional practice for this group of patients, concurrent carboplatin and paclitaxel will be given weekly (paclitaxel (45mg/m2/wk) and carboplatin (AUC=2/wk) for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Active comparator | Conventionally Fractionated Radiotherapy (ConRT) - Standard of Care Receives: Radiation: Conventionally Fractionated Radiotherapy (ConRT) |
| Arm 1 | Experimental | Hypofractionated radiotherapy (HypoRT) - Investigational Receives: Radiation: Hypofractionated radiotherapy (HypoRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Local Failure
Measured: Completion of the two year follow up period for all patients.
Secondary outcomes (4)
Overall Survival
Measured: Completion of the two year follow up period for all patients.
Cancer Specific survival
Measured: Completion of the two year follow up period for all patients.
Treatment Related Toxicity
Measured: Completion of the two year follow up period for all patients.
Quality of Life
Measured: Completion of the two year follow up period for all patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trans Tasman Radiation Oncology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Ball, MBBSMDRANZCR, Study chair, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014130
- Sponsor's protocol ID
- TROG 09.02
- Acronym
- CHISEL
- Status last verified
- Jul 2017
- First submitted
- 8 Oct 2009
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ball D, Mai GT, Vinod S, Babington S, Ruben J, Kron T, Chesson B, Herschtal A, Vanevski M, Rezo A, Elder C, Skala M, Wirth A, Wheeler G, Lim A, Shaw M, Schofield P, Irving L, Solomon B; TROG 09.02 CHISEL investigators. Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Lancet Oncol. 2019 Apr;20(4):494-503. doi: 10.1016/S1470-2045(18)30896-9. Epub 2019 Feb 12.
PubMed 30770291
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 (CHISEL)
- ClinicalTrials.gov ID
- NCT01014130
- Acronym / sponsor ID
- CHISEL / TROG 09.02
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Hypofractionated, Stereotactic Radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Trans Tasman Radiation Oncology GroupUniversity, hospital or other
- Study start
- Dec 2009 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 16 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Although surgery is the most effective treatment for early lung cancer, many patients are not fit enough for an operation. The alternative treatment to surgery is standard radiotherapy which is normally 'fractionated' that is, given as a number of small doses over a period of weeks. Experience has shown that many small treatments are safer than using a few large doses (hypofractionation) because there is less risk of damage to normal tissues.
Recent advances in technology have however resulted in greater accuracy and with it a reduction in the amount of normal tissue affected by the radiation, so the risks of hypo-fractionation damaging normal tissue are of less concern. Initial results obtained with hypo-fractionated radiotherapy for early stage non-small cell lung cancer indicate that it may be more effective in controlling the cancer. However, it has never been compared directly with standard fractionation in a randomised trial, so this study aims to determine if hypo-fractionation is more effective, results in longer life expectancy and if it is just as safe as standard fractionation.
Detailed description
This is a multicentre randomised phase III trial comparing hypo-fractionated ("stereotactic') radiotherapy with conventional radiotherapy with or without chemotherapy in patients with inoperable stage 1 peripherally located non-small cell lung cancer.
The accepted standard of care for stage 1 non-small cell lung cancer (NSCLC), that is, T1 or T2 tumors that have not metastasised to the regional lymph nodes, is surgical resection. However, many patients with lung cancer have significant cardiovascular and respiratory co morbidities which render them unfit for an operation. For these patients, the standard of care is radiotherapy - conventional fractionation (ConRT) which is administered as 20-30 fractions over a period of four to six weeks. This reduces the likelihood of long term damage to incidentally irradiated normal tissues compared with non-fractionated treatment. Local failure for this method, varies considerably between reports ranging from 6-70% with a median value of 40% using a current best practice for inoperable NSCLC dose of about 60 Gy. Concomitant chemotherapy in addition to CF improves local progression free survival by 16% at two years compared with radiotherapy alone.
Highly conformal hypo-fractionated image guided radiotherapy is an emerging technically complex method for precision irradiation of stage 1 NSCLC using doses with a higher biological effect than can be achieved with standard treatment techniques. Although rates of local control using hypo-fractionation appear greater, there are risks with serious late toxicity. However, there is recent evidence that 54-57Gy delivered in 3 fractions can be delivered safely with no excessive toxicity, provided the tumour has a peripheral location, the chest wall is not included in the high dose volume and the treatment plan is highly conformal. Although hypo-fractionation under the above conditions appears to be tolerable, and is associated with high levels of local control, the results of a small number of phase II trials cannot be regarded as sufficient evidence to recommend it as the standard of care for inoperable stage I NSCLC.
This randomised phase III trial tests whether highly conformal hypo-fractionated image guided radiotherapy for peripherally located inoperable T1 and T2a NSCLC using a dose of 54 Gy in three fractions results in superior control of disease at the primary site compared with standard care consisting of conventionally fractionated radiotherapy with or without concomitant chemotherapy.
Treatment summary: Investigational arm - radical radiotherapy to a total dose of 54 Gy in 3 fractions of 18 Gy each, delivered weekly on days 0, 7 and 14 with a maximum deviation of +/- 2 days from the specified time allowed. Conventional arm - radical radiotherapy to a total dose of 60-66 Gy in 30-33 daily 2 Gy fractions over 6 weeks, with or without chemotherapy consisting of weekly carboplatin at an AUC of 2 and paclitaxel 45 mg/m2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Active comparator | Radiation: Conventionally Fractionated Radiotherapy (ConRT)Conventionally Fractionated Radiotherapy (ConRT) - Standard of Care |
| Arm 1 | Experimental | Radiation: Hypofractionated radiotherapy (HypoRT)Hypofractionated radiotherapy (HypoRT) - Investigational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 (UICC TNM stage, 7th Ed, 2009), based on FDG PET/CT performed within 4-6 weeks prior to randomisation. T stage should be based on tumour size alone (i.e. no atelectasis).
- An ECOG performance status score of 0 or 1.
- The tumour has a peripheral location, defined as at least 1 cm beyond the mediastinum and 2 cm beyond the bifurcation of the lobar bronchi.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiotherapy (HypoRT)Also: HypoRT, Radiotherapy, RTHighly conformal hypofractionated radiotherapy to a total dose of 54 Gy given in 3 fractions of 18 Gy each, delivered weekly on days 0, 7 and 14 with a maximum deviation of +/- 2 days from the specified time allowed. | Radiation | Arm 1 |
| Conventionally Fractionated Radiotherapy (ConRT)Also: ConRT, Radiotherapy, RTStandard radiotherapy to a total dose of 60-66 Gy prescribed to an isodose covering the PTV. It will be delivered as 30-33 fractions over a period of six to six and a half weeks. If the use of chemotherapy is the institutional practice for this group of patients, concurrent carboplatin and paclitaxel will be given weekly (paclitaxel (45mg/m2/wk) and carboplatin (AUC=2/wk) for 6 weeks. | Radiation | Arm 2 |
Primary outcome
Time to Local Failure
Time frame: Completion of the two year follow up period for all patients.
4 secondary outcomes
Overall Survival
Time frame: Completion of the two year follow up period for all patients.
Cancer Specific survival
Time frame: Completion of the two year follow up period for all patients.
Treatment Related Toxicity
Time frame: Completion of the two year follow up period for all patients.
Quality of Life
Time frame: Completion of the two year follow up period for all patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Derived from this study: PubMed 30770291Ball D, Mai GT, Vinod S, Babington S, Ruben J, Kron T, Chesson B, Herschtal A, Vanevski M, Rezo A, Elder C, Skala M, Wirth A, Wheeler G, Lim A, Shaw M, Schofield P, Irving L, Solomon B; TROG 09.02 CHISEL investigators. Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Lancet Oncol. 2019 Apr;20(4):494-503. doi: 10.1016/S1470-2045(18)30896-9. Epub 2019 Feb 12.
- Click here for more information about this study on the TROG websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ball, MBBSMDRANZCR study chair
Peter MacCallum Cancer Centre, Australia
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypofractionated radiotherapy (HypoRT) and Conventionally Fractionated Radiotherapy (ConRT) in people with Non Small Cell Lung Cancer, run by Trans Tasman Radiation Oncology Group at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Local Failure (time frame: Completion of the two year follow up period for all patients.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01014130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017; AzTrials last refreshed its copy on 1 Nov 2026.