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NCT Number: NCT05883800

Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

On-couch adaptive radiotherapy

Radiation

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

Other names: online ART

Primary outcomes

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

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

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

Secondary outcomes

  1. Number of participants that require alteration of chemotherapy due to toxicity

    Time frame: From treatment week 3 up to week 20

    Alterations of chemotherapy, defined as dose-reduction or pre-maturely stopping chemotherapy administration

  2. Number of patients with disease related treatment failure

    Time frame: 5 years after surgery

    Disease-related treatment failure include the first of any of the following events:

    (i) During treatment: Non-radical resection of primary tumor (R2 resection) or un-fit of for surgery due to progression, death from treatment (ii) During, or after treatment: Loco-regional recurrence (including regrowth after potential watch-and-wait), distant metastasis (including M re-staging at surgery), death from rectal cancer, second primary rectal cancer.

  3. Number of patients with pathological complete response (pCR)

    Time frame: At surgery i.e. in treatment week 23-28

    pCR after completion of the intended or tolerated TNT

  4. Tumour regression grade

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

    Radiological based clinical response evaluation on MR (mrTRG)

  5. Overall survival

    Time frame: Follow-up until 5 years or death

    Overall survival from time of inclusion until death

  6. Incidence of late gastro-intestinal toxicity equal or higher than grade 2

    Time frame: 5 years

    Incidence of late gastro-intestinal events (e.g.diarrhea, rectal hemorrhage, rectal and/or abdominal pain) from therapy graded according to CTCAE ver. 5.

Other outcomes

  1. Bowel exposure

    Time frame: Treatment week 1-2

    Radiation dose to bowel

  2. Immunogenic alterations from TNT

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

    Presence of selected immune cells

  3. Perfusion changes on MR

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

    Changes in perfusion from contrast-enhanced MR

  4. Diffusion changes on MR

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

    Changes in diffusion from diffusion-weighted MR

  5. Patient reported general outcome measures

    Time frame: Baseline and up to 5 years of the study

    Quality of life using EORTC qlq-c30 questionnaire

  6. Patient reported colo-rectal outcome measures

    Time frame: Baseline and up to 5 years of the study

    Quality of life using EORTC qlq-cr29 questionnaire

  7. Patient reported bowel-related outcome measures

    Time frame: Baseline and up to 5 years of the study

    Quality of life using low anterior resection syndrome (LARS) score

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Pilskog, PhD

CONTACT

[email protected]

95890659 ext. 0047

Unn Hege Lilleøren, MD

CONTACT

[email protected]

92054547 ext. 0047

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy

Acronym: TNT-RECORD

Important dates

Study start
2023
Primary completion
2026
Study completion
2031
First posted
Jun 1, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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