Pencil Beam Proton Therapy for Recurrences in Anal Cancer... | NCT05055635

Studies
Pencil Beam Proton Therapy for Recurrences in Anal Cancer Patients Previously Treated With Radiotherapy (DACG 5)

NCT05055635

Sponsor

University of Aarhus

Status

Recruiting

Last Update Posted

Sep 24, 2021Actual

Enrollment

55Estimated

Phase

Phase 2

Conditions

Anal Cancer
Recurrent Anal Cancer

Interventions

Pencil beam proton therapy

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Jul 6, 2027Estimated

Completion Date

Jul 6, 2030Estimated

First Submitted Date

Jul 8, 2021

First Submission Date that Met QC Criteria

Sep 14, 2021

First Posted Date

Sep 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2021

Last Update Posted Date

Sep 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This protocol aims to determine toxicity and efficacy of re-irradiation for patients with recurrences from anal cancers with dose-escalated pencil beam proton therapy either pre-operative for marginally resectable recurrences or as a definitive treatment strategy (un-resectable, operation declined etc.). The over-all aim is to improve local tumor control with acceptable side effects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doseescalated pencil beam proton therapy	Experimental	Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day.	Radiation: Pencil beam proton therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pencil beam proton therapy	Radiation	Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day	Doseescalated pencil beam proton therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Local control	MRI	12 months

Secondary Outcomes

Measure	Description	Time Frame
Local re-recurrence		6 and 24 months
Progression free survival		3-5 year FU
Overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recurrent anal cancer
Bioptically verified (squamous cell carcinoma)
Available dose plan from primary radiotherapy
Previous RT (>30Gy EQD2)
Evaluated in MDT-conferences (Herlev, Aarhus)
Age>18 years
PS 0-2
Adequate organ function
Written informed consent

Exclusion Criteria:

Distant metastases deemed without curative intended treatment options (PET-CT)
Unable to undergo MRI, PET-CT
Inability to attend full course radiotherapy and follow up in the outpatient clinic.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Camilla Kronborg, MD, PhD	Contact	+45 78 45 00 00		camkro@rm.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danish Centre for Particle Therapy	Recruiting	Aarhus N	Aarhus	8200	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001005	Anus Neoplasms

Ancestor Terms

ID	Term
D012004	Rectal Neoplasms
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided