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Rectal CancerPhase 2NOAHS-ARCNCT04864067

No Operation After Short Course Radiotherapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer

A Phase 2 study testing Oxaliplatin, 5-Fluoracil and Leucovorin in people with Rectal Cancer, run by Servicio de Salud Metropolitano Sur Oriente at 3 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
Oxaliplatin, 5-Fluoracil and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesChile
Study dates
9 Jun 2021to 5 May 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Chile3 sites

  • Complejo Asistencial Doctor Sótero del Rio

    Santiago, RM

  • Hospital La Florida

    Santiago, RM

  • Hospital Padre Hurtado

    Santiago, RM

Other trials in Chile

About this study

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

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).

Read the 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.

Conditions
Rectal Cancer
Being tested
Oxaliplatin, 5-Fluoracil, Leucovorin, Capecitabine, 5x5 Gy
Keywords
Rectal Cancer, Radiotherapy, Neoadjuvant therapy, Adenocarcinoma
Medical subject headings
Rectal Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxaliplatinDrug

    Also called All Brands

    Consolidation Chemotherapy

  • 5-FluoracilDrug

    Also called All Brands

    Consolidation Chemotherapy

  • LeucovorinDrug

    Also called All Brands

    Consolidation Chemotherapy

  • CapecitabineDrug

    Also called All Brands

    Consolidation Chemotherapy

  • 5x5 GyRadiation

    Neoadjuvant Radiotherapy

  • Quality of Life QuestionnairesBehavioural

    Quality of Life Evaluation (LARS Score, IIEF, FSFI, I-PSS and EORTC QLQ-C30)

  • DRE/ EndoscopyProcedure or surgery

    Flexible Sigmoidoscopy and Digital Rectal Exam

Study groups in NCT04864067
Study groupRoleWhat they receive
Short Course Radiotherapy and Consolidation ChemotherapyExperimentalThis 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.
Receives: Drug: Oxaliplatin; Drug: 5-Fluoracil; Drug: Leucovorin; Drug: Capecitabine; Radiation: 5x5 Gy; Behavioral: Quality of Life Questionnaires; Procedure: DRE/ Endoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 years

  2. Quality of Life and Funcional Outcomes

    Standardized evaluation using validated questionnaires comparing patients undergoing TME versus WW patients in the cohort

    Measured: 3 years

Secondary outcomes (1)

  1. Adverse events

    Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start9 Jun 2021
  3. Primary completion5 May 2026
  4. Study completion5 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study was designed as a single-arm phase II trial with complete response as the primary endpoint - the composite of pCR after surgery and sustained cCR (≥1 year) during watch-and-wait surveillance. The null hypothesis was a local historical pCR rate of 12% after neoadjuvant chemoradiotherapy plus TME. Assuming an expected complete response rate of 30%, 48 evaluable patients were required for 80% power at a one-sided α of 0.05. A protocol amendment was approved by the Ethics Committee before any interim data were reviewed. It introduced two statistical refinements: a formalized interim analysis using Lan-DeMets α-spending with O'Brien-Fleming boundaries (early efficacy: ≥9/24 responders or p\<.006), and a futility stopping rule to protect patients from a non-beneficial regimen. No changes were made to the endpoint, eligibility, treatment, or follow-up. All amendments were Ethics Committee-approved before investigators reviewed any unblinded data.
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04864067
Sponsor's protocol ID
FONDECYT 11201291
Acronym
NOAHS-ARC
Status last verified
May 2026
First submitted
25 Apr 2021
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Quezada-Diaz FF, Bercz A, Escobar JL, Caire N, Diaz-Feldman LE, Manriquez E, Carvajal G. No operation after short-course radiotherapy followed by consolidation chemotherapy in locally advanced rectal cancer (NOAHS-ARC): study protocol for a prospective, phase II trial. Int J Colorectal Dis. 2025 Mar 18;40(1):69. doi: 10.1007/s00384-025-04850-9.

    PubMed 40100473

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, 5-Fluoracil and Leucovorin in people with Rectal Cancer, run by Servicio de Salud Metropolitano Sur Oriente at 3 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of pathological and sustained clinical response (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04864067, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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