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Health Condition(s) or Problem
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Locally Advanced Non-small Cell Lung Cancer
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Lay Summary
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The I-START trial is designed to determine the highest doses of radiotherapy that can safely
be used in locally advanced non-small cell lung cancer (NSCLC). Patients with NSCLC who are
expected to live longer than three months and are fit to receive radical radiotherapy
(radiotherapy given with curative intent) will be eligible to participate. All trial
participants will receive 20 doses (called fractions) of radiotherapy. Evidence is available
that suggests increasing the dose of radiotherapy given per fraction may improve both local
control of the cancer and survival in some patients. However, high dose radiotherapy can
damage normal tissues as well as the tumour. The dose of radiotherapy that can be used to
treat lung cancer is limited by the normal tissues close to the cancer. For most of these
normal tissues (lung, spinal cord and heart) the maximum safe radiotherapy dose that can be
given is known. The maximum safe dose of radiotherapy for the oesophagus (gullet) is not
currently known.
The trial will be split into two parts:
1. For those participants where the oesophagus will receive a high dose of radiation due
to it lying close to the cancer, the first part of the trial will establish the maximum
safe dose of radiotherapy to the oesophagus. The first group of participants will
receive a slightly higher dose than is currently used to treat lung cancer. If these
participants do not have any significant side effects, a second group of participants
will receive a slightly higher dose than the first group. This process will continue
incrementally until side effects from the treatment become evident, thus demonstrating
the maximum dose that can safely be given. Once the maximum safe dose to the oesophagus
is known this will be classed as the recommended Phase II dose and all further patients
entering the trial will receive no more than this dose to the oesophagus.
2. For those participants where the cancer is a safe distance from their oesophagus, the
highest dose of radiotherapy that does not exceed the known safe dose limits of the
normal structures (lung, spinal cord and heart) will be used.
The findings of both parts of this study will determine whether increasing the dose of
radiotherapy for NSCLC patients is a tolerable, safe and effective treatment. If the results
are positive then this new treatment may be compared against the best currently available
standard treatments in a future larger randomised (Phase III) trial.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
1. Histologically or cytologically confirmed stage II - IIIb NSCLC (see appendix II)
2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or
operable but the patient refuses surgery
3. Disease which can be encompassed within a radical radiotherapy treatment plan in
keeping with standard practice at the participating centre
4. WHO Performance Status 0 or 1 (Appendix III)
5. Adequate respiratory function: FEV1 = 1.0 litre, DLco (transfer factor) = 40% of
predicted and Kco (DLco/VA) > 40% predicted on baseline lung function tests
6. Blood Haemoglobin = 10g/dL
7. No prior thoracic radiotherapy
8. Age = 16 years
9. Considered fit to receive trial treatment
10. Estimated life expectancy of more than 3 months
11. Written informed consent obtained
12. Patient consents for electronic CT scan and planning data to be used for future
research
13. Patient is available for follow up
Exclusion Criteria:
1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection,
hypercalcaemia or very symptomatic ischaemic heart disease)
2. Previous or current malignant disease likely to interfere with protocol treatment
3. Pancoast tumours
4. Connective tissue disorders (e.g. Scleroderma, Systemic Lupus Erythematosus)
5. Interstitial lung disease
6. Women who are pregnant or lactating
7. Women of childbearing potential who are not using adequate contraceptive precautions
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Who cannot enter the trial
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Inclusion Criteria:
1. Histologically or cytologically confirmed stage II - IIIb NSCLC (see appendix II)
2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or
operable but the patient refuses surgery
3. Disease which can be encompassed within a radical radiotherapy treatment plan in
keeping with standard practice at the participating centre
4. WHO Performance Status 0 or 1 (Appendix III)
5. Adequate respiratory function: FEV1 = 1.0 litre, DLco (transfer factor) = 40% of
predicted and Kco (DLco/VA) > 40% predicted on baseline lung function tests
6. Blood Haemoglobin = 10g/dL
7. No prior thoracic radiotherapy
8. Age = 16 years
9. Considered fit to receive trial treatment
10. Estimated life expectancy of more than 3 months
11. Written informed consent obtained
12. Patient consents for electronic CT scan and planning data to be used for future
research
13. Patient is available for follow up
Exclusion Criteria:
1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection,
hypercalcaemia or very symptomatic ischaemic heart disease)
2. Previous or current malignant disease likely to interfere with protocol treatment
3. Pancoast tumours
4. Connective tissue disorders (e.g. Scleroderma, Systemic Lupus Erythematosus)
5. Interstitial lung disease
6. Women who are pregnant or lactating
7. Women of childbearing potential who are not using adequate contraceptive precautions
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What will happen
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Radiation; Radiotherapy; All patients will receive radiotherapy to the primary lung tumour and any demonstrated nodal involvement. Patients will be given radiotherapy of a dose between 58 and 65Gy in 20 fractions. Dose will be determined by the patients' group.; Group 1A; Group 1B; Phase II
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Primary aim
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Phase I: Establish the maximum tolerated dose (MTD) to the oesophagus to use as the recommended Phase II dose.; Phase II: Toxicity rate (grade 3 and 4) at three months.
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Secondary Aim
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Phase I: Chronic oesophagitis or stricture occurring/persisting two months or more after completion of radiotherapy; 2 months; No; Pase II: Local control at three months (to include complete response, partial response and stable disease); 3 months; No; Phase II: Feasibility; 2 years; No; Phase II: Time to Local Progression; measured in days from the day of trial entry to the date of first clinical evidence of progressive disease at the primary site; 2 years; No; Phase II: Time to distant metastases measured in days; 2 years; No; Phase II: Overall Survival; measured in days, from the day of trial entry to the day of death (from any cause); 2 years; No; Phase II: Toxicity; pulmonary, oesophageal, spinal cord and cardiac grade 3 or 4 toxicity occurring up to three months after radiotherapy; 3 months; No; Phase II: Radiotherapy Quality Assurance. A detailed QA program will be in place to ensure adherence to the protocol. Major and minor deviations will be documented; 2 years; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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http://www.wctu.org.uk/trial.php?trial=i-start; http://public.ukcrn.org.uk/search/; http://www.controlled-trials.com/ISRCTN74841904; http://www.rttrialsqa.org.uk/
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Recruitment Status
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Recruiting
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Nation
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Wales, England
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Location
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Cardiff, Liverpool
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