Hypofractionated Radiotherapy (Stereotactic) Versus Conventional Radiotherapy for Inoperable Early Stage I Non-small Cell Lung Cancer (NSCLC) (CHISEL)
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ClinicalTrials.gov Identifier: NCT01014130 |
Recruitment Status : Unknown
Verified July 2017 by Trans Tasman Radiation Oncology Group.
Recruitment status was: Active, not recruiting
First Posted : November 16, 2009
Last Update Posted : July 12, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | October 8, 2009 | |||
First Posted Date ICMJE | November 16, 2009 | |||
Last Update Posted Date | July 12, 2017 | |||
Actual Study Start Date ICMJE | December 2009 | |||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Time to Local Failure [ Time Frame: Completion of the two year follow up period for all patients. ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Hypofractionated Radiotherapy (Stereotactic) Versus Conventional Radiotherapy for Inoperable Early Stage I Non-small Cell Lung Cancer (NSCLC) | |||
Official Title ICMJE | 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) | |||
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. 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. |
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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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non Small Cell Lung Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Actual Enrollment ICMJE |
101 | |||
Original Estimated Enrollment ICMJE |
100 | |||
Estimated Study Completion Date ICMJE | December 2020 | |||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, New Zealand | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01014130 | |||
Other Study ID Numbers ICMJE | TROG 09.02 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Trans Tasman Radiation Oncology Group | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Trans Tasman Radiation Oncology Group | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Trans Tasman Radiation Oncology Group | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |