NCT01014130

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
101

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_3

Geographic Reach
2 countries

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

11 years

First QC Date

October 8, 2009

Last Update Submit

July 10, 2017

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung CancerHypofractionatedStereotactic Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Time to Local Failure

    Completion of the two year follow up period for all patients.

Secondary Outcomes (4)

  • Overall Survival

    Completion of the two year follow up period for all patients.

  • Cancer Specific survival

    Completion of the two year follow up period for all patients.

  • Treatment Related Toxicity

    Completion of the two year follow up period for all patients.

  • Quality of Life

    Completion of the two year follow up period for all patients.

Study Arms (2)

Arm 2

ACTIVE COMPARATOR

Conventionally Fractionated Radiotherapy (ConRT) - Standard of Care

Radiation: Conventionally Fractionated Radiotherapy (ConRT)

Arm 1

EXPERIMENTAL

Hypofractionated radiotherapy (HypoRT) - Investigational

Radiation: Hypofractionated radiotherapy (HypoRT)

Interventions

Hypofractionated radiotherapy (HypoRT)RADIATION

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.

Also known as: HypoRT, Radiotherapy, RT
Arm 1
Conventionally Fractionated Radiotherapy (ConRT)RADIATION

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.

Also known as: ConRT, Radiotherapy, RT
Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Canberra Hospital

Canberra, Australian Capital Territory, 2605, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Calvary Mater Hosipital

Newcastle, New South Wales, 2298, Australia

Location

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2069, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Peter Maccallum Cancer Centre

Bendigo, Victoria, 3952, Australia

Location

Austin Hospital

Heidelburg, Victoria, 3084, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Peter MacCallum Cancer Centre - Box Hill

Melbourne, Victoria, 3128, Australia

Location

Peter MacCallum Cancer Centre - Morrabbin

Melbourne, Victoria, 3165, Australia

Location

Alfred Hospital

Prahran, Victoria, 3181, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Auckland Hospital

Epsom, Auckland, 1023, New Zealand

Location

Midcentral District Health Board

Roslyn, Palmerston North, 4442, New Zealand

Location

Canterbury District Health Board

Christchurch, 4710, New Zealand

Location

Related Publications (1)

  • 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.

    PMID: 30770291DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • David Ball, MBBSMDRANZCR

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2009

First Posted

November 16, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 12, 2017

Record last verified: 2017-07

Locations

AU(16)NZ(3)