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Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer (TNT-RECORD)

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
On-couch adaptive radiotherapy
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Intervention: daily on-couch adaptive radiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of participants that require alteration of chemotherapy due to toxicity
Alterations of chemotherapy, defined as dose-reduction or pre-maturely stopping chemotherapy administration
Number of patients with disease related treatment failure
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.
Number of patients with pathological complete response (pCR)
pCR after completion of the intended or tolerated TNT
Tumour regression grade
Radiological based clinical response evaluation on MR (mrTRG)
Overall survival
Overall survival from time of inclusion until death
Incidence of late gastro-intestinal toxicity equal or higher than grade 2
Incidence of late gastro-intestinal events (e.g.diarrhea, rectal hemorrhage, rectal and/or abdominal pain) from therapy graded according to CTCAE ver. 5.

Full Information

First Posted
February 24, 2023
Last Updated
July 31, 2023
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05883800
Brief Title
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer
Acronym
TNT-RECORD
Official Title
TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention: daily on-couch adaptive radiotherapy
Intervention Type
Radiation
Intervention Name(s)
On-couch adaptive radiotherapy
Other Intervention Name(s)
online ART
Intervention Description
A new treatment plan, guided by volumetric images, is created at each treatment session
Primary Outcome Measure Information:
Title
Incidence of acute gastro-intestinal toxicity equal or higher than grade 2
Description
Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5.
Time Frame
Up to administration of the last course of chemotherapy or week 22, whichever comes first
Secondary Outcome Measure Information:
Title
Number of participants that require alteration of chemotherapy due to toxicity
Description
Alterations of chemotherapy, defined as dose-reduction or pre-maturely stopping chemotherapy administration
Time Frame
From treatment week 3 up to week 20
Title
Number of patients with disease related treatment failure
Description
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.
Time Frame
5 years after surgery
Title
Number of patients with pathological complete response (pCR)
Description
pCR after completion of the intended or tolerated TNT
Time Frame
At surgery i.e. in treatment week 23-28
Title
Tumour regression grade
Description
Radiological based clinical response evaluation on MR (mrTRG)
Time Frame
Baseline to response evaluation on MR in up to week 25 of the study
Title
Overall survival
Description
Overall survival from time of inclusion until death
Time Frame
Follow-up until 5 years or death
Title
Incidence of late gastro-intestinal toxicity equal or higher than grade 2
Description
Incidence of late gastro-intestinal events (e.g.diarrhea, rectal hemorrhage, rectal and/or abdominal pain) from therapy graded according to CTCAE ver. 5.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Bowel exposure
Description
Radiation dose to bowel
Time Frame
Treatment week 1-2
Title
Immunogenic alterations from TNT
Description
Presence of selected immune cells
Time Frame
Baseline and at surgery i.e. in treatment week 23-28
Title
Perfusion changes on MR
Description
Changes in perfusion from contrast-enhanced MR
Time Frame
Baseline and at MR response evaluation up to week 25 of the study
Title
Diffusion changes on MR
Description
Changes in diffusion from diffusion-weighted MR
Time Frame
Baseline and at MR response evaluation up to week 25 of the study
Title
Patient reported general outcome measures
Description
Quality of life using EORTC qlq-c30 questionnaire
Time Frame
Baseline and up to 5 years of the study
Title
Patient reported colo-rectal outcome measures
Description
Quality of life using EORTC qlq-cr29 questionnaire
Time Frame
Baseline and up to 5 years of the study
Title
Patient reported bowel-related outcome measures
Description
Quality of life using low anterior resection syndrome (LARS) score
Time Frame
Baseline and up to 5 years of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Pilskog, PhD
Phone
95890659
Ext
0047
Email
sara.margareta.cecilia.pilskog@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Unn Hege Lilleøren, MD
Phone
92054547
Ext
0047
Email
unn.hege.lilleoren@helse-bergen.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Unn Hege Lilleøren, MD
Organizational Affiliation
Dept. of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

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