Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

NCT ID: NCT05883800

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2031-12-31

Brief Summary

Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).

This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.

Detailed Description

This is a prospective single-arm study investigating the benefit of on-couch adaptation for locally advanced rectal cancer patients prescribed with pre-operative sequential short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6) or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of the patient at each radiotherapy session. Firstly, the study will investigate if on-couch adaptation result in less gastro-intestinal adverse events, secondly it will reveal if this possible reduction lead to more patients being able to fulfill all cycles of prescribed chemotherapy.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Intervention: daily on-couch adaptive radiotherapy

Group Type: EXPERIMENTAL

On-couch adaptive radiotherapy

Intervention Type: RADIATION

A new treatment plan, guided by volumetric images, is created at each treatment session

Interventions

On-couch adaptive radiotherapy

A new treatment plan, guided by volumetric images, is created at each treatment session

Intervention Type: RADIATION

Other Intervention Names

online ART

Eligibility Criteria

Inclusion Criteria

• Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered.
• ECOG status ≤ 1
• Being willing and able to give full written consent for participation

Exclusion Criteria

• Previous rectal cancer treatment
• Previous irradiation to the treatment area e.g. prostate cancer
• Hip prosthesis
• Contraindications to MRI
• Pregnancy
• Abnormal DPYD genotype
• Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Unn Hege Lilleøren, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Sara Pilskog, PhD

Role: CONTACT

sara.margareta.cecilia.pilskog@helse-bergen.no

95890659 ext. 0047

Unn Hege Lilleøren, MD

Role: CONTACT

unn.hege.lilleoren@helse-bergen.no

92054547 ext. 0047

Other Identifiers

402056

Identifier Type: -

Identifier Source: org_study_id