No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer (NOAHS-ARC)
Primary Purpose
Rectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
Oxaliplatin
5-Fluoracil
Leucovorin
Capecitabine
5x5 Gy
Quality of Life Questionnaires
DRE/ Endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Radiotherapy, Neoadjuvant therapy, Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of adenocarcinoma of the rectum
- Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on Magnetic Resonance Imaging (MRI)
- Tumors < 7cm from anal verge (palpable)
- No prior history of rectal cancer
Exclusion Criteria
- Patients with tumors >7cm from anal verge
- ECOG >1,
- Contraindication for chemotherapy: Hemoglobin <8, White Blood Count <4000, Platelets <100,000, Creatinine Clearance <50ml/min, Total Bilirubin <5mg/dl,
- Stage IV at diagnosis
- Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months.
- Congestive heart failure
- Peripheral neuropathy
- Previous pelvic radiotherapy
- Prior rectal cancer treatment
- Pregnancy or nursery
- Any contraindications to MRI (e.g. patients with pacemakers)
- Indication of pelvic exenteration
- Impossibility to consent.
Sites / Locations
- Complejo Asistencial Doctor Sótero del RioRecruiting
- Hospital La FloridaRecruiting
- Hospital Padre HurtadoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Short Course Radiotherapy and Consolidation Chemotherapy
Arm Description
This arm will receive short course radiotherapy (5x5 Gy) during 1 week. Between 7 to 14 days after radiotherapy, patient will receive 9 cycles of FOLFOX. CapeOX may be given as alternative for FOLFOX.
Outcomes
Primary Outcome Measures
Rate of pathological and sustained clinical response
Combined number of patients with pathological response in the surgical specimen and patients in a Watch and Wait protocol with a sustained clinical response longer than a year.
Quality of Life and Funcional Outcomes
Standardized evaluation using validated questionnaires comparing patients undergoing TME versus WW patients in the cohort
Secondary Outcome Measures
Adverse events
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Full Information
NCT ID
NCT04864067
First Posted
April 25, 2021
Last Updated
October 24, 2022
Sponsor
Servicio de Salud Metropolitano Sur Oriente
1. Study Identification
Unique Protocol Identification Number
NCT04864067
Brief Title
No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
Acronym
NOAHS-ARC
Official Title
No Operation After Short Course Equivalent Dose (Ht) Radiation Therapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer: The Prospective, Single Arm NOAHS-ARC Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Servicio de Salud Metropolitano Sur Oriente
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
This study is designed to explore the hypothesis that in patients with a Locally advanced rectal cancer (LARC) treated with a Total neoadjuvant therapy (TNT) strategy based on short course radiotherapy (5x5Gy) followed by neoadjuvant consolidation chemotherapy is associated with a higher rate of pathological clinical response and sustained (>1year) complete clinical response when compared to an historical cohort treated with long course chemoradiation therapy (CRT), total mesorectal excision (TME) and adjuvant chemotherapy (ACT).
Detailed Description
Non-operative management with a Watch and Wait (W&W) strategy has been advocated for selected patients with a locally advanced rectal cancer (LARC) and a complete clinical response (cCR) after neoajuvant (NA) treatment.
In this context, total neoadjuvant therapy (TNT), i.e the use of radiotherapy and full dose of post-operative chemotherapy as part of NA treatment, has emerged as a strategy to enhance treatment response.
Currently, TNT has reported higher rates of pCR and organ preservation when compared to current standard of care. However, the best TNT strategy is still unknown. We therefore hypothesize that in LARC patients, the use of a TNT strategy based on short course RT followed by consolidation chemotherapy is associated with a higher rate of pCR and sustained (>1year) cCR when compared to an historic cohort.
The main aim of the present proposal is to assess the effects of a standardized TNT model in LARC patients as a strategy for enhanced pCR/sustained cCR. For this purpose, we propose the following experimental model: In primary Aim 1 we will study if the effects of a TNT strategy over patients with a LARC enhance the rate of pCR/sustained cCR by (1) evaluating the compliance and toxicity of a TNT strategy as a proof of concept of its applicability, (2) assessing the rate of cCR at the end of TNT and (3) assessing the rate of pCR in the surgically managed subgroup and sustained cCR (>1year) in the W&W subgroup. Additionally, in primary Aim 2, we will determine if patients with a W&W strategy have better functional outcomes and quality of life (QoL) than patients treated with TME after TNT by (1) using validated questionnaires for the evaluation of bowel, sexual and urinary function for W&W and TME patients and (2) by evaluating the QoL using a widely-used standardized questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Cancer, Radiotherapy, Neoadjuvant therapy, Adenocarcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short Course Radiotherapy and Consolidation Chemotherapy
Arm Type
Experimental
Arm Description
This arm will receive short course radiotherapy (5x5 Gy) during 1 week. Between 7 to 14 days after radiotherapy, patient will receive 9 cycles of FOLFOX. CapeOX may be given as alternative for FOLFOX.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
All Brands
Intervention Description
Consolidation Chemotherapy
Intervention Type
Drug
Intervention Name(s)
5-Fluoracil
Other Intervention Name(s)
All Brands
Intervention Description
Consolidation Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
All Brands
Intervention Description
Consolidation Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
All Brands
Intervention Description
Consolidation Chemotherapy
Intervention Type
Radiation
Intervention Name(s)
5x5 Gy
Intervention Description
Neoadjuvant Radiotherapy
Intervention Type
Behavioral
Intervention Name(s)
Quality of Life Questionnaires
Intervention Description
Quality of Life Evaluation (LARS Score, IIEF, FSFI, I-PSS and EORTC QLQ-C30)
Intervention Type
Procedure
Intervention Name(s)
DRE/ Endoscopy
Intervention Description
Flexible Sigmoidoscopy and Digital Rectal Exam
Primary Outcome Measure Information:
Title
Rate of pathological and sustained clinical response
Description
Combined number of patients with pathological response in the surgical specimen and patients in a Watch and Wait protocol with a sustained clinical response longer than a year.
Time Frame
3 years
Title
Quality of Life and Funcional Outcomes
Description
Standardized evaluation using validated questionnaires comparing patients undergoing TME versus WW patients in the cohort
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of adenocarcinoma of the rectum
Clinical Stage II (T3-4, N-) or Stage III (any T, N+) based on Magnetic Resonance Imaging (MRI)
Tumors < 7cm from anal verge (palpable)
No prior history of rectal cancer
Exclusion Criteria
Patients with tumors >7cm from anal verge
ECOG >1,
Contraindication for chemotherapy: Hemoglobin <8, White Blood Count <4000, Platelets <100,000, Creatinine Clearance <50ml/min, Total Bilirubin <5mg/dl,
Stage IV at diagnosis
Coronary artery disease, either no treated or recent acute coronary syndrome in the last 12 months.
Congestive heart failure
Peripheral neuropathy
Previous pelvic radiotherapy
Prior rectal cancer treatment
Pregnancy or nursery
Any contraindications to MRI (e.g. patients with pacemakers)
Indication of pelvic exenteration
Impossibility to consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Felipe F Quezada-Diaz, MD
Phone
+ 562 25762401
Email
ffquezad@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole M Caire, MD
Phone
+ 562 25762401
Email
cairenicole@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe F Quezada-Diaz, MD
Organizational Affiliation
Complejo Asistencial Doctor Sótero del Rio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicole M Caire, MD
Organizational Affiliation
Complejo Asistencial Doctor Sótero Del Río
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Asistencial Doctor Sótero del Rio
City
Santiago
State/Province
RM
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe F Quezada-Diaz, MD
Phone
+ 562 25762401
Email
ffquezad@gmail.com
First Name & Middle Initial & Last Name & Degree
Nicolle M Caire, MD
Email
cairenicole@gmail.com
Facility Name
Hospital La Florida
City
Santiago
State/Province
RM
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose A Hernandez, MD
Email
drjoseanhernandez@gmail.com
Facility Name
Hospital Padre Hurtado
City
Santiago
State/Province
RM
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebastian Pradenas, MD
Email
sebapradenas@gmail.com
12. IPD Sharing Statement
Learn more about this trial
No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer
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