THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Systemic Anti-Cancer Treatment Protocol
Temozolomide with Concomitant Radiotherapy
PROTOCOL REF: MPHATEMCR
(Version No: 1.2)
The protocol has been temporarily amended – please see the Oral SACT
Operational Changes during Covid-19. Amendments may include less frequent
blood monitoring, telephone SACT assessments and longer durations of
treatment being dispensed.
Approved for use in:
Adult patients with newly-diagnosed glioblastoma multiforme concomitantly with
radiotherapy and subsequently as monotherapy treatment (see separate protocol).
Dosage:
Concomitant temozolomide and radiotherapy
Drug Dosage Route Frequency
Temozolomide 75mg/m² oral Daily for 42 days
Followed by temozolomide monotherapy (see separate protocol), to be reviewed by
oncologist 4 weeks after completion of radiotherapy.
Drug Dosage Route Frequency
Temozolomide 150mg/m² oral Once daily for 5 days
At Cycle 2, the dose is escalated
to 200 mg/m2, if tolerated, for up
to 6 cycles
Supportive treatments:
Moderately emetic:
Ondansetron 8mg daily if required (one hour before temozolomide)
Cyclizine 50mg tablets, three times a day when required
Issue Date: 6th May 2020
Review: May 2023 Page 1 of 4 Protocol reference: MPHATEMCR
Author: Jenny Wood Authorised by: Helen Poulter-Clark & Joanne McCaughey Version No: 1.2
THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Additional Medication:
PCP prophylaxis, particularly if patients on concurrent corticosteroid (dexamethasone) –
co-trimoxazole 960mg PO once a day on Mondays, Wednesdays and Fridays of each
week which should continue for 4 weeks after last cycle, or until lymphocyte counts
return to normal values.
Extravasation risk:
Not applicable
Administration:
Day Drug Dose Route Frequency
30 minutes before
radiotherapy (or on the
1-21 Temozolomide 75mg/m2 PO
morning at weekends) for
21 days
30 minutes before
radiotherapy (or on the
22-42 Temozolomide 75mg/m2 PO
morning at weekends) for
21 days
30 minutes before
radiotherapy (or on the
42-49 Temozolomide (optional) 75mg/m2 PO
morning at weekends) if
needed
Mondays, Wednesdays and
Fridays during treatment
1 to 70 Co-trimoxazole 960mg PO
and for up to 4 weeks after
completion of treatment
During the concomitant phase, temozolomide 75mg/m²/day every day for 42 days, 30
minutes prior to the radiotherapy and in the morning at weekends (non-radiotherapy
days). Temozolomide capsules are to be swallowed whole with a glass of water on an
empty stomach, 1 hour before or after meals.
Once the radiotherapy is completed, there will be a 4 week treatment free period before
the adjuvant cycle commences.
Issue Date: 6th May 2020
Review: May 2023 Page 2 of 4 Protocol reference: MPHATEMCR
Author: Jenny Wood Authorised by: Helen Poulter-Clark & Joanne McCaughey Version No: 1.2
THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Main Toxicities:
Myelosuppresion (thrombocytopenia and neutropenia)
Tiredness and weakness (fatigue) during and after treatment
Alopecia
Nausea and vomiting
Anorexia
An itchy rash and dry skin – severe allergic rash occurs occasionally and requires
discontinuation of temozolomide
Headaches
Constipation
Hepatotoxicity (rare fatal cases have been reported)
Amenorrhoea, but this may only be temporary
Loss of fertility
Pneumocystis carinii pneumonia
Investigations:
Pre Wk1 Wk2 Wk3 Ongoing
Medical Assessment X X X X Every week
Radiographer /
X X X Every week
Nursing Assessment
FBC X X X X Once a week
U&E & LFTs X X X X Once a week
MRI scan X As clinically indicated
Informed Consent X
PS recorded X X X X
Toxicities
X X X X
documented
Weight recorded X X X X Every week
Issue Date: 6th May 2020
Review: May 2023 Page 3 of 4 Protocol reference: MPHATEMCR
Author: Jenny Wood Authorised by: Helen Poulter-Clark & Joanne McCaughey Version No: 1.2
THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST
Dose Modifications and Toxicity Management:
Haematological toxicity
During treatment a complete blood count should be obtained weekly.
If radiotherapy is interrupted continue temozolomide (maximum 49 days total)
Toxicity TMZ interruption TMZ discontinuation
Absolute neutrophil count ≥ 0.5 and ≤ 1.5 x 109/L < 0.5 x 109/L
Platelet count ≥ 10 and ≤ 99 x 109/L < 10 x 109/L
CTC non-haematological toxicity CTC Grade 2 CTC Grade 3 or 4
(except for alopecia, nausea, vomiting)
Hepatic toxicity
Review concurrent medication – particularly anticonvulsants and consider their effect on
LFTs
Stop temozolomide if progressive rise in transaminases or rise in bilirubin
Marrow aplasia
If thrombocytopenia continues after discontinuation of temozolomide with reduction in
neutrophil count, then:
Stop co-trimoxazole
Repeat FBC daily
Add daily filgrastim
Supportive blood product transfusions as necessary
Contact haematologists for advice in severe cases
References:
http://www.medicines.org.uk/EMC/medicine/7027/SPC/Temodal+Capsules/
http://www.medicines.org.uk/emc/PIL.28687.latest.pdf
http://www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/cancer-
drugs/temozolomide
NICE TA 121 June 2007
Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma
Stupp R et al NEJM 2005 352:987-996
Issue Date: 6th May 2020
Review: May 2023 Page 4 of 4 Protocol reference: MPHATEMCR
Author: Jenny Wood Authorised by: Helen Poulter-Clark & Joanne McCaughey Version No: 1.2
