Trial Outcomes & Findings for Study of Weekly Radiotherapy for Bladder Cancer (NCT NCT01810757)

NCT ID: NCT01810757

Last Updated: 2026-01-15

Results Overview

Non-GU CTCAE G3+ treatment-related toxicity occurring within the first 3 months of radiotherapy completing

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

12 weeks from completion of radiotherapy

Results posted on

2026-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Planning Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Overall Study STARTED	32	33
Overall Study COMPLETED	32	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Weekly Radiotherapy for Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Planning n=32 Participants Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning n=33 Participants Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.	Total n=65 Participants Total of all reporting groups
Age, Continuous	84.8 years n=14 Participants	84.1 years n=10 Participants	84.5 years n=24 Participants
Sex: Female, Male Female	8 Participants n=14 Participants	13 Participants n=10 Participants	21 Participants n=24 Participants
Sex: Female, Male Male	24 Participants n=14 Participants	20 Participants n=10 Participants	44 Participants n=24 Participants
Region of Enrollment United Kingdom	32 participants n=14 Participants	33 participants n=10 Participants	65 participants n=24 Participants
Extent of resection Biopsy	10 Participants n=14 Participants	10 Participants n=10 Participants	20 Participants n=24 Participants
Extent of resection Partial resection	10 Participants n=14 Participants	13 Participants n=10 Participants	23 Participants n=24 Participants
Extent of resection Full resection	11 Participants n=14 Participants	9 Participants n=10 Participants	20 Participants n=24 Participants
Extent of resection Unobtainable	1 Participants n=14 Participants	1 Participants n=10 Participants	2 Participants n=24 Participants
Multiple tumours Yes	6 Participants n=14 Participants	7 Participants n=10 Participants	13 Participants n=24 Participants
Multiple tumours No	26 Participants n=14 Participants	26 Participants n=10 Participants	52 Participants n=24 Participants
Histological tumour type Urothelial	31 Participants n=14 Participants	32 Participants n=10 Participants	63 Participants n=24 Participants
Histological tumour type Non-urothelial	1 Participants n=14 Participants	1 Participants n=10 Participants	2 Participants n=24 Participants
Grade Grade 1	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Grade Grade 2	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants
Grade Grade 3	31 Participants n=14 Participants	33 Participants n=10 Participants	64 Participants n=24 Participants
Carcinoma in situ (CIS) present Yes	9 Participants n=14 Participants	11 Participants n=10 Participants	20 Participants n=24 Participants
Carcinoma in situ (CIS) present No	22 Participants n=14 Participants	22 Participants n=10 Participants	44 Participants n=24 Participants
Carcinoma in situ (CIS) present Unobtainable	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants
Clinical stage T1	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Clinical stage T2	24 Participants n=14 Participants	21 Participants n=10 Participants	45 Participants n=24 Participants
Clinical stage T3a	1 Participants n=14 Participants	5 Participants n=10 Participants	6 Participants n=24 Participants
Clinical stage T3b	5 Participants n=14 Participants	5 Participants n=10 Participants	10 Participants n=24 Participants
Clinical stage T4a	2 Participants n=14 Participants	2 Participants n=10 Participants	4 Participants n=24 Participants
Age adjusted Charlson Comorbidity index score 5	1 Participants n=14 Participants	0 Participants n=10 Participants	1 Participants n=24 Participants
Age adjusted Charlson Comorbidity index score 6	14 Participants n=14 Participants	13 Participants n=10 Participants	27 Participants n=24 Participants
Age adjusted Charlson Comorbidity index score 7	11 Participants n=14 Participants	5 Participants n=10 Participants	16 Participants n=24 Participants
Age adjusted Charlson Comorbidity index score 8	4 Participants n=14 Participants	6 Participants n=10 Participants	10 Participants n=24 Participants
Age adjusted Charlson Comorbidity index score 9	2 Participants n=14 Participants	8 Participants n=10 Participants	10 Participants n=24 Participants
Age adjusted Charlson Comorbidity index score 10	0 Participants n=14 Participants	0 Participants n=10 Participants	0 Participants n=24 Participants
Age adjusted Charlson Comorbidity index score 11	0 Participants n=14 Participants	1 Participants n=10 Participants	1 Participants n=24 Participants

PRIMARY outcome

Timeframe: 12 weeks from completion of radiotherapy

Population: Evaluable patient population: This population contains all randomised patients who have received at least one fraction of radiotherapy and are evaluable for the primary endpoint of acute toxicity (i.e. toxicity reported up to 3 months post radiotherapy). Patients had been reviewed for evaluability by the independent Trial steering committee (TSC) blinded to planning method and the TSC's view on evaluability for the primary endpoint has been used to define the evaluable patient population.

Non-GU CTCAE G3+ treatment-related toxicity occurring within the first 3 months of radiotherapy completing

Outcome measures

Outcome measures
Measure	Standard Planning n=30 Participants Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning n=33 Participants Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Proportion of Patients Experiencing Severe Acute Non-genitourinary Side Effects Following Radiotherapy.	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Including only those who had an assessment at 3 months

Presence of cancer in the bladder 3 months after treatment. Presented as the proportion of all patients regardless of treatment allocation (standard and adaptive combined) having evidence of residual tumour.

Outcome measures

Outcome measures
Measure	Standard Planning n=23 Participants Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning n=25 Participants Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Local Disease Control Rate	17 Participants	22 Participants

SECONDARY outcome

Timeframe: Event-free survival estimates at 12 months and 24 months are reported.

Population: Intention to treat population. It was pre-planned in the SAP to combine the two treatment arms together because there is insufficient statistical power to detect clinically meaningful differences.

From randomisation to a maximum follow-up of 30 months. It was pre-planned in the SAP to combine the two treatment arms together because there is insufficient statistical power to detect clinically meaningful differences.

Outcome measures

Outcome measures
Measure	Standard Planning n=65 Participants Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Time to Local Disease Progression KM 12 months	71.7 percentage event-free Interval 55.9 to 82.6	—
Time to Local Disease Progression KM 24 months	47.3 percentage event-free Interval 29.6 to 63.1	—

SECONDARY outcome

Timeframe: Event-free survival estimates at 12 months and 24months are reported.

From randomisation to maximum follow-up of 56 months. It was pre-planned in the SAP to combine the two treatment arms together because there is insufficient statistical power to detect clinically meaningful differences.

Outcome measures

Outcome measures
Measure	Standard Planning n=65 Participants Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Overall Survival KM 24 months	46.2 percentage surviving Interval 33.8 to 57.7	—
Overall Survival KM 12 months	61.5 percentage surviving Interval 48.6 to 72.1	—

SECONDARY outcome

Timeframe: 3 months from the completion of radiotherapy

Population: Including those with 3 month follow up acute toxicity available. Frequency threshold for reporting: Renal and urinary symptom reported in 20% or more of patients with symptoms/toxicity reported.

Assessed by looking at change in symptom scores from pre to post radiotherapy. The number of patients with post-radiotherapy scores lower than their baseline score have been used to calculate the control rate of presenting symptoms and is presented separately for the two randomisation groups.

Outcome measures

Outcome measures
Measure	Standard Planning n=27 Participants Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning n=29 Participants Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
The Control Rate of Presenting Symptoms Urinary incontinence	4 participants	4 participants
The Control Rate of Presenting Symptoms Cystitis	3 participants	8 participants
The Control Rate of Presenting Symptoms Haematuria	4 participants	8 participants
The Control Rate of Presenting Symptoms Nocturia	3 participants	5 participants
The Control Rate of Presenting Symptoms Frequency/Urgency	5 participants	7 participants

SECONDARY outcome

Timeframe: End of treatment, treatment is given over 6 weeks

Population: ITT

Assessed by the number of small or large plans being selected rather than the medium plan for patients in the adaptive planning group. The denominator will be the total number of fractions received in the adaptive planning group.

Outcome measures

Outcome measures
Measure	Standard Planning n=193 Fractions Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
The Proportion of Fractions Benefiting From Adaptive Planning	76 Fractions	—

Adverse Events

Standard Planning

Serious events: 11 serious events

Other events: 32 other events

Deaths: 0 deaths

Adaptive Planning

Serious events: 9 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Professor Emma Hall (Co-Director of ICR-CTSU)

The Institute of Cancer Research, Clinical Trials and Statistics Unit (ICR-CTSU)

Phone: +44 (0)208 722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Standard Planning n=32 participants at risk Standard planning radiotherapy Standard planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.	Adaptive Planning n=33 participants at risk Adaptive planning radiotherapy Adaptive planning radiotherapy: 36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
Gastrointestinal disorders Constipation	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders Abdominal pain	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Blood and lymphatic system disorders Anaemia	6.2% 2/32 • Number of events 2 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders Back pain	6.2% 2/32 • Number of events 2 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations Blood creatinine increased	6.2% 2/32 • Number of events 2 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	12.1% 4/33 • Number of events 4 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations Blood phosphorus decreased	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations Blood potassium increased	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations Blood sodium decreased	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations Blood urea increased	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations Bronchopneumonia	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Cardiac disorders Cardiac failure congestive	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders Decreased appetite	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders Dehydration	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	9.1% 3/33 • Number of events 3 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders Diarrhoea	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
General disorders Fatigue	6.2% 2/32 • Number of events 2 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders Gastrointestinal haemorrhage	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders Hydronephrosis	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders Hyperkalaemia	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	6.1% 2/33 • Number of events 2 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders Hypoglycaemia	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Metabolism and nutrition disorders Hyponatraemia	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	9.1% 3/33 • Number of events 4 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Gastrointestinal disorders Nausea	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Reproductive system and breast disorders Perineal pain	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations Pneumonia	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders Renal failure	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders Renal failure acute	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Renal and urinary disorders Renal failure chronic	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations Sepsis	0.00% 0/32 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	3.0% 1/33 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Infections and infestations Urinary tract infection	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M
Investigations Weight decreased	3.1% 1/32 • Number of events 1 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M	0.00% 0/33 • Adverse event data was collected up to 24 months. Adverse event data were collected at the following timepoints: Baseline Acute toxicity: RT week1, RT week2, RT week3, RT week4, RT week5, RT week6, Post RT week4, Post RT 3M Late toxicity: 6M, 12M, 24M