Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

NCT05883800 | Recruiting DMC

• 1 other identifier: 402056
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of acute gastro-intestinal toxicity equal or higher than grade 2

  Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5.

  Up to administration of the last course of chemotherapy or week 22, whichever comes first

Secondary Outcomes (6)

• Number of participants that require alteration of chemotherapy due to toxicity

  From treatment week 3 up to week 20

• Number of patients with disease related treatment failure

  5 years after surgery

• Number of patients with pathological complete response (pCR)

  At surgery i.e. in treatment week 23-28

• Tumour regression grade

  Baseline to response evaluation on MR in up to week 25 of the study

• Overall survival

  Follow-up until 5 years or death

Other Outcomes (7)

• Bowel exposure

  Treatment week 1-2

• Immunogenic alterations from TNT

  Baseline and at surgery i.e. in treatment week 23-28

• Perfusion changes on MR

  Baseline and at MR response evaluation up to week 25 of the study

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention: daily on-couch adaptive radiotherapy

Radiation: On-couch adaptive radiotherapy

Interventions

On-couch adaptive radiotherapy RADIATION

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

Also known as: online ART

Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

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

Study Officials

• Unn Hege Lilleøren, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Pilskog, PhD

CONTACT

95890659; sara.margareta.cecilia.pilskog@helse-bergen.no

Unn Hege Lilleøren, MD

CONTACT

92054547; unn.hege.lilleoren@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: June 1, 2023
• Study Start: June 22, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: March 19, 2024

Record last verified: 2023-07

Locations

NO (1)