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Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

Primary Purpose

Rectal Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Neoadjuvant Chemoradiotherapy
Adjuvant Chemotherapy
Consolidation Chemotherapy
Sponsored by
Larissa University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasms focused on measuring rectal, cancer, neoadjuvant, radiotherapy, chemotherapy, mesorectal, excision

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed rectal adenocarcinoma
  • cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1
  • Multidisciplinary tumor board decision for neoadjuvant treatment
  • Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging
  • Patient 18 to 80 years old
  • General health condition status WHO 0-1
  • Absence of co-morbidities that may affect treatment
  • Neutrophils >1,500 / mm3, platelets >100,000 / mm3, hemoglobin> 10 g / dL, normal creatinine, and creatinine clearance> 50 mL / min
  • Signed informed consent of the patient

Exclusion Criteria:

  • Distant metastases
  • Non-resectable cancer
  • Contraindications for the administration of chemotherapy
  • Previous pelvic radiotherapy or chemotherapy
  • History of inflammatory bowel disorders
  • History of angina, acute myocardial infarction or heart failure
  • Active sepsis or systemic infection
  • Untreated physical and mental disability
  • Synchronous malignancy
  • Pregnancy or breast-feeding
  • Lack of compliance with the protocol process
  • Non-granting of signed informed consent

Sites / Locations

  • Department of Surgery, University Hospital of LarissaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy

Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy

Arm Description

The experimental group will receive the standard 5-week neoadjuvant chemoradiotherapy (CRT). Thereafter, all patients will commence consolidation chemotherapy. At the 6th week after the end of CRT, patients will undergo MRI re-staging: In case of non-response (mrTRG 5) they will be submitted immediately to surgery, and, subsequently, excluded from the trial. In case of response (mrTRG 2-4) they will receive consolidation chemotherapy for the whole waiting period between the end of CRT and surgery - 12 weeks.

The control group will receive the standard 5-week neoadjuvant chemoradiotherapy regimen. Six weeks after completion the patient will be re-staged with rectal MRI and depending on the response will be operated (TME): immediately in case of non-response (mrTRG 5) or after an additional 6-week delay (overall 12 weeks after the end of chemoradiotherapy) in case of partial response (mrTRG 2-4). Adjuvant chemotherapy will be, also, administered.

Outcomes

Primary Outcome Measures

Disease Free Survival
Occurence of Disease Free Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Secondary Outcome Measures

Complete Pathological Response
Occurence of Complete Pathological Response. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Postoperative Complication
Occurence of postoperative complications based on the Clavien Dindo Classification. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Length of Hospital Stay
Postoperative time that the patient can be safely discharged. Measurement unit: days. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria
Readmission
Occurence of postoperative readmission. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Negative Resection Margin
Occurence of Negative Resection Margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Overall Survival
Occurence of Overall Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Chemotherapy Toxicity
Occurence of Chemotherapy Toxicity. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Local Recurrence
Occurence of Local Recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Treatment Compliance
Occurence of Treatment Compliance. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'

Full Information

First Posted
August 9, 2022
Last Updated
October 5, 2023
Sponsor
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05496491
Brief Title
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Official Title
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2022 (Actual)
Primary Completion Date
August 30, 2025 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Larissa 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
No

5. Study Description

Brief Summary
The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.
Detailed Description
Colorectal cancer is the second leading cause of cancer-related deaths worldwide. It is estimated that 10% of cancer mortality is attributed to malignant neoplasms of the colon and rectum. More specifically, in the United States alone, 53,200 colorectal cancer deaths were reported. The current treatment of choice for locally advanced rectal cancer (Stage II/ III) is the combination of neoadjuvant chemoradiation followed by radical surgical resection based on the principles of total mesorectal excision (TME) after a 8-12 weeks period. Therapy is usually completed with the administration of adjuvant chemotherapy based on oxaliplatin and fluoropyrimidines. This combined approach allowed the reduction of local recurrence at levels around 5%. Despite the impressive results in local control, the same was not confirmed for the long-term, overall survival. Possible explanations to that are: a) the compliance and completion of the treatment schemes during the postoperative period were low and b) there was a delay in the administration of adjuvant chemotherapy; both could lead to subclinical metastatic disease progression. On the basis of achieving both goals, (i.e., local control through neoadjuvant radiotherapy and metastatic disease control through systemic chemotherapy) the administration of the two therapies in the preoperative period was proposed, in the form of combined or total neoadjuvant therapy. Additional theoretical benefits of total neoadjuvant therapy is faster defunctioning stoma reversal, as well as, the possibility of a more accurate evaluation of the tumor biological behavior, thus enabling a safer staging for patients who would be candidates for a watch and wait protocol. Furthermore, for patients who will eventually undergo surgery, total neoadjuvant therapy could probably increase R0 resection and sphincter-preservation rates. However, many researchers question the safety and efficacy of total neoadjuvant therapy. First, the administration of neoadjuvant chemotherapy significantly increases the risk of severe toxicity from cytotoxic agents. At the same time, according to the results of one of the largest prospective randomized trials, the addition of neoadjuvant chemotherapy into the treatment algorithm did not offer any advantage in the pathological response, 5-year overall and disease-free survival rates. Finally, there is considerable heterogeneity in the current literature, most likely reflecting the different schemes used in different trials regarding the radiotherapy regimen, the chemotherapy regimen as well as the sequence of each one in each protocol. The investigators believe that it is difficult to interpret any differences in results when multiple parameters have been changed in a comparative trial. For this reason when testing the current standard neoadjuvant protocol to the new trend of total neoadjuvant therapy it was decided to keep the same scheme and timing for the experimental group while the only parameter which was different was the use of the classic chemotherapy scheme during the waiting period following chemoradiation and before surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
Keywords
rectal, cancer, neoadjuvant, radiotherapy, chemotherapy, mesorectal, excision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will employ a prospective, parallel randomized-controlled design
Masking
None (Open Label)
Masking Description
There will be no blindness at the level of the patient, the treating physicians (surgeon, oncologist, radiotherapist) and the researcher who will record the data.
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy
Arm Type
Experimental
Arm Description
The experimental group will receive the standard 5-week neoadjuvant chemoradiotherapy (CRT). Thereafter, all patients will commence consolidation chemotherapy. At the 6th week after the end of CRT, patients will undergo MRI re-staging: In case of non-response (mrTRG 5) they will be submitted immediately to surgery, and, subsequently, excluded from the trial. In case of response (mrTRG 2-4) they will receive consolidation chemotherapy for the whole waiting period between the end of CRT and surgery - 12 weeks.
Arm Title
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy
Arm Type
Active Comparator
Arm Description
The control group will receive the standard 5-week neoadjuvant chemoradiotherapy regimen. Six weeks after completion the patient will be re-staged with rectal MRI and depending on the response will be operated (TME): immediately in case of non-response (mrTRG 5) or after an additional 6-week delay (overall 12 weeks after the end of chemoradiotherapy) in case of partial response (mrTRG 2-4). Adjuvant chemotherapy will be, also, administered.
Intervention Type
Radiation
Intervention Name(s)
Neoadjuvant Chemoradiotherapy
Other Intervention Name(s)
nCRT
Intervention Description
5-week neoadjuvant radiotherapy regimen (28 x 1.8 Gy) combined with Capecitabine (bid 800 mg/m2, twice daily, on days 1-33-38)
Intervention Type
Drug
Intervention Name(s)
Adjuvant Chemotherapy
Other Intervention Name(s)
AC
Intervention Description
8 cycles of CAPOX (Capecitabine bid 1000 mg/m2, twice daily, day 1-14, every 3 weeks and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively, 12 cycles of folinate, fluorouracil and oxaliplatin (FOLFOX)
Intervention Type
Drug
Intervention Name(s)
Consolidation Chemotherapy
Other Intervention Name(s)
CC
Intervention Description
CAPOX (Capecitabine bid1000 mg/m2 and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively FOLFOX
Primary Outcome Measure Information:
Title
Disease Free Survival
Description
Occurence of Disease Free Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
3 years postoperatively
Secondary Outcome Measure Information:
Title
Complete Pathological Response
Description
Occurence of Complete Pathological Response. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
1 month postoperatively
Title
Postoperative Complication
Description
Occurence of postoperative complications based on the Clavien Dindo Classification. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
1 month postoperatively
Title
Length of Hospital Stay
Description
Postoperative time that the patient can be safely discharged. Measurement unit: days. The patient will be discharged, when it is ensured that is medically safe to be released. In particular, as the exit time of the patient, will be regarded the time that the patient will fulfil the Clinical Discharge Criteria
Time Frame
Maximum time frame 39 days postoperatively
Title
Readmission
Description
Occurence of postoperative readmission. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
1 month postoperatively
Title
Negative Resection Margin
Description
Occurence of Negative Resection Margin. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
1 month postoperatively
Title
Overall Survival
Description
Occurence of Overall Survival. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
3 years postoperatively
Title
Chemotherapy Toxicity
Description
Occurence of Chemotherapy Toxicity. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
3 years postoperatively
Title
Local Recurrence
Description
Occurence of Local Recurrence. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
3 years postoperatively
Title
Treatment Compliance
Description
Occurence of Treatment Compliance. If such an episode occurs, then it will be defined as=1 'YES' If such an episode does not occur, then it will be defined as=0 'NO'
Time Frame
3 years postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed rectal adenocarcinoma cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1 Multidisciplinary tumor board decision for neoadjuvant treatment Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging Patient 18 to 80 years old General health condition status WHO 0-1 Absence of co-morbidities that may affect treatment Neutrophils >1,500 / mm3, platelets >100,000 / mm3, hemoglobin> 10 g / dL, normal creatinine, and creatinine clearance> 50 mL / min Signed informed consent of the patient Exclusion Criteria: Distant metastases Non-resectable cancer Contraindications for the administration of chemotherapy Previous pelvic radiotherapy or chemotherapy History of inflammatory bowel disorders History of angina, acute myocardial infarction or heart failure Active sepsis or systemic infection Untreated physical and mental disability Synchronous malignancy Pregnancy or breast-feeding Lack of compliance with the protocol process Non-granting of signed informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantinos Perivoliotis, MD
Phone
2413501000
Ext
0030
Email
kperi19@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
George Tzovaras, Prof
Phone
2413502804
Ext
0030
Email
gtzovaras@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Perivoliotis, MD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Tzovaras, Prof
Organizational Affiliation
University Hospital of Larissa
Official's Role
Study Director
Facility Information:
Facility Name
Department of Surgery, University Hospital of Larissa
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Perivoliotis, MD
Phone
00302413501000
Email
kperi19@gmail.com
First Name & Middle Initial & Last Name & Degree
George Tzovaras, Professor
Phone
00302413502804
Email
gtzovaras@hotmail.com
First Name & Middle Initial & Last Name & Degree
Konstantinos Perivoliotis, MD
First Name & Middle Initial & Last Name & Degree
Ioannis Baloyiannis, Prof
First Name & Middle Initial & Last Name & Degree
Ioannis Samaras, MD
First Name & Middle Initial & Last Name & Degree
Athanasios Kotsakis, Prof
First Name & Middle Initial & Last Name & Degree
Georgios Kyrgias, Prof

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual patient data
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Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

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