Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients

NCT05816980 | Completed Phase 2

• 1 other identifier: KFE-1506
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 2

Brief Summary

This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.

Conditions

Rectal Cancer; Recurrence; Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

• Resection rate

  Rate of complete pathological resection R0

  At surgery

Secondary Outcomes (5)

• Physician reported Toxicity

  Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery

• QoL assessment according to QLQ-CR29

  Pre-treatment and 12 months post surgery

• QoL assessment according to EORTC QLQ-C30

  Pre-treatment and 12 months post surgery

• Recurrence rate

  Rate of re-recurrence at 6, 12 and 36 months post surgery.

• Comparative dose planning study

  The VMAT plans generated before treatment start (baseline) is compared to IMPT plans.

Study Arms (1)

Single

OTHER

Re-irradiation consisting of hyperfractionated IMRT, 40.8 Gy in 1.2 fractions twice daily 5/7 days weekly, with oral capecitabine 825 mg/m2 BID on radiotherapy treatment days. Re-staging performed 4-6 weeks after the last dose, followed by surgery, when feasible.

Radiation: Hyperfractionated external beam radiation

Interventions

Hyperfractionated external beam radiation RADIATION

40.8Gy/34 fractions (1.2Gy BID 5/7 days with minimum 6 hours interval) Concurrent capecitabine (825 mg/m2 BID 5/7 days)

Single

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally recurrent rectal cancer
• Previous pelvic RT for rectal cancer and surgery
• Potentially resectable by MRI and palpation by MDT evaluation
• Absence of non-resectable distant metastases by PET-CT
• Age ≥ 18
• Adequate organ function
• Acceptable bowel and bladder function
• Acceptance for TR sampling

You may not qualify if:

• Central small recurrences deemed immediate resectable
• Previous radiotherapy \<12 month prior to recurrence
• Non-resectable systemic or regional disease
• Unable to undergo MRI or PET-CT
• Medical comorbidities precluding radical surgery

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Oslo University Hospital: collaborator

Study Sites (2)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Rectal Neoplasms; Recurrence; Radiation Injuries

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Karen-Lise G Spindler, MD, Phd

  Aarhus University Hospital, Depart. Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patients are enrolled according to protocol criteria for hyperfractionated IMRT re-irradiation.

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: April 18, 2023
• Study Start: January 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); DK (1)