Trial Outcomes & Findings for Evaluation of Late Toxicity Following Intensity-Modulated Radiotherapy and Two Image-Guided Strategies With Corresponding Treatment Margins. (NCT NCT03254420)

NCT ID: NCT03254420

Last Updated: 2025-10-01

Results Overview

assessment of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: NA
• Target enrollment: 74 participants
• Primary outcome timeframe: between 3 months and 2 years after radiation period
• Results posted on: 2025-10-01

Participant Flow

Participant milestones

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy
Overall Study STARTED	29	45
Overall Study COMPLETED	26	44
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n=29 Participants moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction n=45 Participants moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Total n=74 Participants Total of all reporting groups
Age, Continuous	68 years n=29 Participants	70 years n=45 Participants	69.5 years n=74 Participants
Sex: Female, Male Female	0 Participants n=29 Participants	0 Participants n=45 Participants	0 Participants n=74 Participants
Sex: Female, Male Male	29 Participants n=29 Participants	45 Participants n=45 Participants	74 Participants n=74 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: between 3 months and 2 years after radiation period

Population: failure : presence of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period success : absence of grade \> 2 late pelvic toxicities between 3 months and 2 years after radiation period

assessment of grade > 2 late pelvic toxicities between 3 months and 2 years after radiation period

Outcome measures

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n=26 Participants moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction n=44 Participants moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy
Assessment of Grade > 2 Late Pelvic Toxicities failure	5 Participants	5 Participants
Assessment of Grade > 2 Late Pelvic Toxicities success	21 Participants	39 Participants

SECONDARY outcome

Timeframe: at 5 years after the radiotherapy

evaluate at 5 years with PSA dosage

Outcome measures

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n=26 Participants moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction n=44 Participants moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy
Biological Relapse-free Survival	26 participants	37 participants

SECONDARY outcome

Timeframe: at 5 years after the radiotherapy

evaluate et 5 years after the treatment with radiological exam

Outcome measures

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n=26 Participants moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction n=44 Participants moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy
Uncomplicated Survival (Local Recurrence or Metastatic Recurrence)	26 participants	41 participants

SECONDARY outcome

Timeframe: from the baseline to 5 years after the radiotherapy

number of death from baseline to 5 years after the treatment

Outcome measures

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n=26 Participants moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction n=44 Participants moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy
Overall Survival	0 participants	2 participants

Adverse Events

Image-guided Radiation Therapy (IGRT) With Standard Margins

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Calypso Tracking System With Margin Reduction

Serious events: 9 serious events

Other events: 44 other events

Deaths: 2 deaths

Serious adverse events

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n=26 participants at risk moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction n=44 participants at risk moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy
Metabolism and nutrition disorders hemovhromatosis	3.8% 1/26 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy	0.00% 0/44 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Hepatobiliary disorders lithiasis choledocholithiasis grade 3	3.8% 1/26 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy	0.00% 0/44 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Reproductive system and breast disorders prostatitis grade 3	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	4.5% 2/44 • Number of events 2 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Blood and lymphatic system disorders thrombocytopenia grade 4	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) basela cell carcinoma grade 2	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
General disorders vascular stent stenosis grade 3	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Vascular disorders peripheral artery stenosis grade 3	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) malignant melanoma grade 2	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) colon cancer metastatic grade 5	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Nervous system disorders cerebral hematoma grade 3	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Gastrointestinal disorders large instestine polyp grade 2	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy

Other adverse events

Measure	Image-guided Radiation Therapy (IGRT) With Standard Margins n=26 participants at risk moderate hypofractionation during 4 weeks moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy	Calypso Tracking System With Margin Reduction n=44 participants at risk moderate hypofractionation during 4 weeks after calypso beacon implant 10 days before Calypso beacon implant: Calypso beacon implant before radiotherapy moderate hypofractionation Radiotherapy: moderate hypofractionation Radiotherapy
Blood and lymphatic system disorders blood and lymphatic	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Eye disorders ocular infection	3.8% 1/26 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy	0.00% 0/44 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Gastrointestinal disorders gastrointestinal disorders	61.5% 16/26 • Number of events 16 • adverse event data were collected from the baseline to 5 years after the radiotherapy	63.6% 28/44 • Number of events 28 • adverse event data were collected from the baseline to 5 years after the radiotherapy
General disorders general disorders and reaction at the site of administration	38.5% 10/26 • Number of events 10 • adverse event data were collected from the baseline to 5 years after the radiotherapy	29.5% 13/44 • Number of events 13 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Infections and infestations Infections and infestations	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Hepatobiliary disorders hepatobiliary disorders	3.8% 1/26 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy	0.00% 0/44 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Investigations investigations	3.8% 1/26 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Musculoskeletal and connective tissue disorders musculoskeletal and connective tissue disorders	3.8% 1/26 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy	4.5% 2/44 • Number of events 2 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Nervous system disorders nervous system disorder	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Psychiatric disorders psychiatric disorders	23.1% 6/26 • Number of events 6 • adverse event data were collected from the baseline to 5 years after the radiotherapy	29.5% 13/44 • Number of events 13 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Renal and urinary disorders renal and urinary disorders	100.0% 26/26 • Number of events 26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	95.5% 42/44 • Number of events 42 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Reproductive system and breast disorders reproductive system and breast disorders	73.1% 19/26 • Number of events 19 • adverse event data were collected from the baseline to 5 years after the radiotherapy	70.5% 31/44 • Number of events 31 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms malignant	0.00% 0/26 • adverse event data were collected from the baseline to 5 years after the radiotherapy	9.1% 4/44 • Number of events 4 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Respiratory, thoracic and mediastinal disorders respiratory, thoracic and mediastinal disorder	3.8% 1/26 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy	0.00% 0/44 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Skin and subcutaneous tissue disorders skin and cubcutaneous tissue disorders	7.7% 2/26 • Number of events 2 • adverse event data were collected from the baseline to 5 years after the radiotherapy	2.3% 1/44 • Number of events 1 • adverse event data were collected from the baseline to 5 years after the radiotherapy
Vascular disorders vascular disorders	30.8% 8/26 • Number of events 8 • adverse event data were collected from the baseline to 5 years after the radiotherapy	22.7% 10/44 • Number of events 10 • adverse event data were collected from the baseline to 5 years after the radiotherapy

Additional Information

Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation

INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

Phone: 0467613102

Email: drci-icm105@icm.unicancer.fr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place