1. No category

RADIOTHERAPY PROTOCOL
Document Title:
Document Type:
Stereotactic Body Radiotherapy for Non-Small Cell Lung
Cancer (54-60 Gy in 3-8 fractions)
Clinical Guideline
Subject:
Standard Care Plan
Approved by:
Currency:
Review date:
Author(s):
Standard care plan for stereotactic body radiotherapy for non-small-cell lung
cancer
References
Lagerwaard FJ, Haasbeek CJ, Smit EF et al. Outcomes of risk-adapted fractionated
stereotactic radiotherapy for stage I non-small cell lung cancer. Int J Radiat
Oncol Biol Phys 2008;70:685-92
Nagata, Y., K. Takayama, Y. Matsuo, et al., Clinical outcomes of a phase I/II study of
48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer
using a stereotactic body frame. Int J Radiat Oncol Biol Phys 2005. 63(5): p.
1427.
Nyman, J., K.A. Johansson, and U. Hulte?n, Stereotactic hypofractionated
radiotherapy for stage I non-small cell lung cancer - Mature results for
medically inoperable patients. Lung Cancer, 2006. 51(1): p. 97.
Onishi, H., H. Shirato, Y. Nagata, et al., Hypofractionated stereotactic radiotherapy
(HypoFXSRT) for stage I non-small cell lung cancer: updated results of 257
patients in a Japanese multi-institutional study. J Thorac Oncol, 2007. 2(7
Suppl 3): p. S94-100.
Senan S, Burgers S, Samson MJ, van Klaveren RJ, Oei SS, van Sornsen de Koste J, et
al. Can elective nodal irradiation be omitted in stage III non-small-cell lung
cancer? Analysis of recurrences in a phase II study of induction chemotherapy
and involved-field radiotherapy. Int J Radiat Oncol Biol Phys 2002;54:9991006.
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1.NSCLC%20_SBRT_Care%20plan[1]
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Neil Bayman
Care Plan Template
Stereotactic Body Radiation Therapy (SBRT) for Patients with Early Stage Non-small
Cell Lung Cancer: A Resource. UK SBRT Consortium, September 2009
Timmerman, R., R. McGarry, C. Yiannoutsos, et al., Excessive toxicity when treating
central tumors in a phase II study of stereotactic body radiation therapy for
medically inoperable early-stage lung cancer. J Clin Oncol, 2006. 24(30): p.
4833-9.
Wulf, J., U. Hadinger, U. Oppitz, et al., Stereotactic radiotherapy of targets in the lung
and liver. Strahlentherapie und Onkologie, 2001. 177(12): p. 645.
Patient group
 Early stage NSCLC not suitable for surgery
 Clinical stages of: T1N0M0, T2 (≤5cm) N0M0 or T3 (≤5cm) N0M0
Indications
 Early stage NSCLC not suitable for surgery (see above)
 Lesion not within a previous radical radiotherapy field
 Any histological subtype of NSCLC
 MDT consensus of NSCLC if not able to confirm histologically
 ECOG PS 0-2 (selected cases with PS 3)
 Radiotherapy target volume is likely to be within radiotherapy planning
constraints as judged by a clinical oncologist
 The UK SBRT consortium currently recommends that treatment should be
reserved for peripheral lesions outside a 2cm radius of main airways and
proximal bronchial tree. However there is emerging data that proximal
tumours can be safely treated with minimal toxicity using 8 fractions (see
Lagerwaard paper), and such tumours may be treated in the future.
Cautions
 Adequate lung function (typically FEV1 >40% predicted and KCO >40%
predicted). However, the evidence for correlation of lung function with
respiratory toxicity is poor, hence these parameters serve only as a guide.
Therefore, radical treatment is not precluded with lung function below these
arbitrary levels with careful patient consent and consideration of anticipated
PTV and V20.
Evidence
Regimes recommended by the UK SBRT consortium for SBRT treatment of
NSCLC in the UK are 54Gy in 3 fractions, 60Gy in 5 fractions and 60Gy in 8
fractions. There are many retrospective data supporting excellent outcomes with these
dose and fractions.
Outcome
Retrospective data gives local control of 80-95% at 3 years which is superior
to standard conformal external beam radical radiotherapy, and comparable local
control to surgery. 2 year overall survival ranges from 65% to 90%, again superior to
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the predicted 45% 2 year overall survival from radical external beam radiotherapy
(see table 1).
Toxicity
Atelectasis ≥ Grade 2 occurs in less than 5 %, pneumonitis ≥ Grade 2 occurs
in about 5%, rib fractures occur in 5-20%. These figures however include data from
RTOG 0236 which included treatment of proximal tumours, and treated tumours in
contact with chest wall with 3 fractions. Our practice excludes proximal tumours and
we treat tumours in contact with chest wall with 5 fractions, and we expect lower
toxicities.
Table from Clinical Review of Evidence for SBRT, National Radiotherapy Implementation Group, 2011
1. Initial investigations and work up prior to start of treatment
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1.1.
Diagnostic review and work up should usually include:
Pathology/Cytology confirmed diagnosis of NSCLC (MDT consensus of
NSCLC diagnosis if not able to confirm histologically)
Stage of disease determined and documented
o CT Abdomen/thorax
o Bronchoscopy
o PETCT
o EBUS/mediastinoscopy if radilogically suspicious mediastinal lymph
nodes
o Biopsy of supraclavicular lypmph node if radiologically suspicious of
malignancy
Clinical assessment and documentation of current disease related symptoms
Performance status recorded
Co-morbidities recorded
Smoking status recorded
FH recorded
Concomitant medications recorded and stopped if necessary
Lung function test desirable
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
Patient consented for aims, practicalities and toxicity of radical external-beam
radiotherapy
1.2.
MDT meeting
Case must have been through the relevant diagnostic MDT prior to commencing
treatment.
2. Stereotactic Body Radiotherapy Technique for NSCLC
http://discover/documents/default.aspx?Details=Y&Doc_ID=5077
(see also Senan, S., et al., Literature-based recommendations for treatment planning
and execution in high-dose radiotherapy for lung cancer. Radiother Oncol, 2004.
71(2): 139-46. )
Please also refer to the UK SBRT consortium guidelines.
2.1. Patient treatment position and set-up
Supine, breathing normally using an external immobilisation device with arms
immobilised above the head in most cases. Exceptionally, for patients with limited
arm movement or apical cancer, arms may be positioned by the patients’ side and
consideration should be given to a 5 pt shell fixation to aid stability.
Set up should be by reference to anterior and lateral tattoos on stable areas of skin and
bony anatomical landmarks.
2.2. Patient data acquisition
More consideration needs to be given to patient comfort as well as their positional
stability and the reproducibility of their set-up.
Patients should be placed supine in a comfortable and reproducible position, with their
arms above their heads, although alternative positions may be required for individual
patients.
Devices such as customized vacuum bags can be used to achieve patient comfort and
stability.
Custom immobilisation devices can also be used for immobilisation and to facilitate
abdominal compression. The immobilization device should allow for patient and
tumour imaging as necessary using CT, CBCT and/or fluoroscopy, and not interfere
with dose calculation or treatment delivery.
In addition, analgesics +/- mild sedatives and oxygen can be considered to help the
patient maintain the treatment position during each fraction.
Once the patient has been appropriately positioned, 4DCT is used to assess tumour
motion.
2.3. Target volume delineation
Treatment will be planned based on information from bronchoscopy, PET-CT scan if
available and mediastinoscopy or thoracotomy, if performed in addition to CT
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findings. Target volume delineation will be done using both the mediastinal and lung
windows.
Gross Tumour Volume (GTV) = The GTV is defined as the radiologically visible
tumour in the lung, contoured using lung settings. Mediastinal windows may be
suitable for defining tumours proximal to the chest wall. Where available information
from PET/CT will be incorporated into delineating the GTV.
Clinical Target Volume (CTV) = The CTV is the GTV with no margin for
microscopic disease extension. This is the accepted standard in the majority of SBRT
trials.
Internal Target Volume (ITV) = tumour volume obtained using a 4DCT scan. This is
defined as tumour contoured using either the (i) maximum intensity projection scan,
(ii) maximum inspiratory and expiratory scans or (iii) as contoured on all 10 phases of
a 4DCT scan.
Planning Target Volume (PTV) = ITV expanded by isotropic margins of 5mm.
2.4. Organs at risk (delineation and dose constraints)
It is recommended that the following organs at risk are delineated on the CT planning
dataset.
Spinal cord
The spinal cord should be contoured on all slices based on the bony limits of the
spinal canal.
Oesophagus
The oesophagus will be contoured using mediastinal windowing on CT to correspond
to the mucosal, submucosa, and all muscular layers out to the fatty adventitia
Brachial Plexus
The brachial plexus will be contoured using the subclavian and axillary vessels as a
surrogate. This neurovascular complex will be contoured starting proximally at the
bifurcation of the brachiocephalic trunk into the jugular/subclavian veins (or
carotid/subclavian arteries), and following along the route of the subclavian vein to
the axillary vein ending after the neurovascular structures cross the 2nd rib.
Heart
The heart will be contoured along with the pericardial sac. The superior aspect (or
base) for purposes of contouring is defined as the superior aspect of pulmonary artery
(as seen in a coronal reconstruction of the CT scan) and extended inferiorly to the
apex of the heart.
Trachea and proximal bronchial tree
The trachea and bronchial tree will be contoured as two separate structures using lung
windows. For this purpose, the trachea will be divided into two sections: the proximal
trachea and the distal 2 cm of trachea. The proximal trachea will be contoured as one
structure, and the distal 2 cm of trachea will be included in the structure identified as
proximal bronchial tree. Differentiating these structures in this fashion will facilitate
the eligibility requirement for excluding patients with tumours within 2 cm of the
proximal bronchial tree.
Proximal trachea
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Contours should begin 10cm superior to superior extent of PTV or 5cm superior to the
carina (whichever is the more superior) and continue inferiorly to the superior aspect
of the proximal bronchial tree.
Proximal bronchial tree
This will include the most inferior distal 2cm of trachea and the proximal airways on
both sides. The following airways will be included: distal 2cm trachea, carina, right
and left mainstem bronchi, right and left upper lobe bronchi, the bronchus
intermedius, right middle lobe bronchus, lingular bronchus, and the right and left
lower lobe bronchi.
Whole lung
Both lungs should be contoured as one structure using pulmonary windows. All
inflated and collapsed lung should be included. However, GTV and trachea/ipsilateral
bronchus as defined above should not be included. The Lungs-GTV should be kept at
V20< 10%, and V12.5<15%.
2.5. Dose prescription
The dose prescription will be chosen such that 95% of the target volume (PTV)
receives at least the nominal fraction dose.
Radical Radiotherapy doses: 54Gy in 3 fractions or 60Gy in 5-8 fractions. It is
recommended that the inter-fraction interval be at least 40 hours, with a maximum
interval of ideally 4 days between treatment fractions
2.6. Verification:
Standard procedure involves an online cone beam CT correction strategy outlined
below.
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Patient Positioned as per
Set-up Notes
ACQUIRE
CBCT
1
Align the clipbox to bony
anatomy and perform automatic
matching and assess rotation
(tolerance <5 degrees)
PERFORM IMAGE
REGISTRATION:
3 step process
3 mm tolerance
2
Manually match directly to the
tumour in the localization mode.
Match ITV contour to visible
tumour on CBCT
3
Match outside
3mm
tolerance
Match within
3mm
tolerance
Check position of critical OARs
and check for changes in
Patient’s internal anatomy
Shift patient and acquire
verification CBCT and
ENSURE shift is within
tolerance (3mm)
Commence treatment and
repeat CBCT;
(a) prior to any non-coplanar
beams
(b) if any significant patient
movement
(c) if treatment time exceeds
30 mins
2.7. Treatment Delays:

Every effort should be made to deliver the prescribed dose of radiotherapy
within the standard timeframe. If unavoidable delays occur, patient will be
treated on the next available treatment date. The consultant will need to be
notified. It is aimed that despite potential delays all treatment will complete
within 4 weeks. As overall treatment time will be less than 4 weeks, there is no
need for compensation for tumour repopulation.
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3. On treatment assessments
3.1. Clinical assessment by medical team with every fraction including
 Graded documentation of toxicity
 Assessment of disease related symptoms
 Performance status recorded
3.2. Management of treatment related toxicity
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3.2.1 Radiation oesophagitis
Grade 2 oesophagitis – optimise analgesia (consider sucralfate suspension,
paracetamol mucilage, codeine phosphate liquid, oromorph, fentanyl patch).
Advise soft diet/oral dietry supplements if required
Grade 3 oesophagitis - treat as for grade 2 oesophagitis but also consider
admission to The Christie/dietician input/pareteral nutrition if required. Every
effort should be made to continue radiotherapy. Avoid placement of nasogastric tubes
Grade 4 oesophagitis – As for grade 3 oesophagitis but radiotherapy should be
stopped.
3.2.2 Radiation Pneumonitis
Grade 2 pneumonitis - Consider oral steroids/sntibiotics/antifungals
Grade 3 pneumonitis – consider admission to The Christie for high dose IV
steroids/oxygen/antibiotics/antifungals. Alert critical care team. Consider
stopping radiotherapy
Grade 4 pneumonitis – as for grade 3 but will require admission to critical care
and consider ventilatory support if appropriate. Stop radiotherapy.
3.2.3 Radiation dermatitis
Topical treatment with aqueous cream/1% hydrocortisone cream if required
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Post treatment follow-up
 2 week and 4 week post-treatment review with clinical assessment for residual
treatment related toxicity and appropriate investigations at discretion of
clinician.
 Further follow-up as outlined below:
Procedure
Medical History
Physical Examination
Weight
ECOG score
Lung function test
CT scan thorax and abdomen
Chest Xray
Adverse event monitoring
QOL
Months post RT
3
6
9
12
18
24
30
36
42
48
54
60
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Appendices
ECOG PERFORMANCE STATUS*
Grade ECOG
0
Fully active, able to carry on all pre-disease performance without restriction
1
Restricted in physically strenuous activity but ambulatory and able to carry
out work of a light or sedentary nature, e.g., light house work, office work
2
Ambulatory and capable of all selfcare but unable to carry out any work
activities. Up and about more than 50% of waking hours
3
Capable of only limited selfcare, confined to bed or chair more than 50% of
waking hours
4
Completely disabled. Cannot carry on any selfcare. Totally confined to bed
or chair
5
Dead
CTCAE v4.0 Skin and Subcutaneous Tissue Disorders
Grade
Adverse Event
1
2
3
4
5
Oesophagitis
Asymptomatic;
clinical or diagnostic
observations only;
intervention not
indicated
Symptomatic; altered
eating/swallowing; oral
supplements indicated
Severely altered
eating/swallowing; tube
feeding, TPN or
hospitalization indicated
Life-threatening
consequences; urgent
operative intervention
indicated
Pneumonitis
Asymptomatic;
clinical or diagnostic
observations only;
intervention not
indicated
Symptomatic; medical
intervention indicated; limiting
instrumental ADL
Severe symptoms; limiting self
care ADL; oxygen indicated
Life-threatening respiratory
compromise; urgent
intervention indicated (e.g.,
tracheotomy or intubation)
Rash:
dermatitis
associated with
radiation
Faint erythema or dry
desquamation
Moderate to brisk erythema; patchy
moist desquamation, mostly
confined to skin folds and creases;
moderate oedema
Moist desquamation other than
skin folds and creases; bleeding
induced by minor trauma or
abrasion
Skin necrosis or ulceration of
full thickness dermis;
spontaneous bleeding from
involved site; skin graft
indicated
Dyspnoea
Shortness of breath
with moderate
exertion
Shortness of breath with minimal
exertion; Limiting instrumental
ADL
Shortness of breath at rest;
limiting self care ADL
Life-threatening
consequences; urgent
intervention indicated
Death
Fatigue
Fatigue relieved by
rest
Fatigue not relieved by rest; limiting
instrumental ADL
Fatigue not relieved by rest;
limiting self-care ADL
-
-
Chest wall pain
Mild pain
Moderate pain; limiting
instrumental ADL
Severe pain; limiting self care
ADL
-
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Death
Death
Death
Care Plan Template
Cough
Mild symptoms;
nonprescription
intervention indicated
Moderate symptoms, medical
intervention indicated
Severe symptoms; limiting
instrumental ADL
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