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Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy (ReRad II)

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ClinicalTrials.gov Identifier: NCT04695782
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

Study design:

A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer.

Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.


Condition or disease Intervention/treatment Phase
Rectal Cancer Recurrent Radiation: Pencil beam proton radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
Actual Study Start Date : October 10, 2020
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : October 31, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily Radiation: Pencil beam proton radiotherapy
Doseescalated pencil beam proton Therapy
Experimental: Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily Radiation: Pencil beam proton radiotherapy
Doseescalated pencil beam proton Therapy


Outcome Measures
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Primary Outcome Measures :
  1. R0-resection [ Time Frame: 5-6 years ]
    Neo-adjuvant treatment: Rate of pathological complete resection (R0)

  2. 1-year local control [ Time Frame: 6-7 years ]
    Definitive treatment: Rate of 1-year local control rates evaluated by CT or MRI.


Secondary Outcome Measures :
  1. Local recurrence [ Time Frame: 6-8 years ]
    Local re-recurrence determined by imaging 6, 12 and 24 month post treatment

  2. Disease free survival [ Time Frame: 10 years ]
    Disease free survival, defined as time from first day of treatment until first documented sign of disease or death from any course

  3. Overall survival [ Time Frame: 10 years ]
    Overall survival defined as time from first day of treatment to death from any cause

  4. Toxicity [ Time Frame: 5-7 years ]
    Toxicity evaluated by NCI-CTCAE v. 5.0 acute and chronic

  5. Patient reported outcomes [ Time Frame: 5-7 year ]
    Quality of life assessment by EORTC QLQ-c30, QLQ-CR29, supplementary EORTC items, and LARS score. Acute and chronic


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Locally recurrent rectal cancer.

    • Bioptically verified (adenocarcinoma )
    • Available dose plan from primary radiotherapy
    • Previous pelvic RT (>30Gy EQD2)
    • Evaluated in MDT-conferences (Herlev, Aarhus)
    • Age>18 years
    • PS 0-2
    • Adequate organ function
    • Informed consent

Exclusion Criteria:

  • Non-resectable distant metastases (PET-CT)
  • Unable to undergo MRI, PET-CT
  • Inability to attend full course radiotherapy and follow up in the out patient clinic.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04695782


Contacts
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Contact: Camilla Kronborg, MD, PhD +45 78450000 camkro@rm.dk

Locations
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Denmark
Danish Centre for Particle Therapy Recruiting
Aarhus, Denmark, 8200
Contact: Camilla Kronborg, MD, PhD         
Sponsors and Collaborators
University of Aarhus
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04695782    
Other Study ID Numbers: DCPT221020
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Recurrence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes