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Rectal CancerPhase 2NCT05241574

Planned Non-operative Management for Rectal Cancer

A Phase 2 study testing Radiotherapy boost and Additional consolidation chemotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The investigators propose to conduct an observational study on consecutive patients with low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal circumferential extent. Read more about this study

Who is it for?
Any age
Conditions the study is for
Rectal Cancer
What is being tested?
Radiotherapy boost and Additional consolidation chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 sitePoland
Study dates
3 Aug 2021to Oct 2023
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Adenocarcinoma of the rectum classified clinically as T2, T3a-c or T4b but only with superficial infiltration of the vagina or prostate; tumour accessible by digital rectal examination; tumour ≤5 cm in length and ≤50% of rectal circumferential extent; N0-N2, but mesorectal node <7 mm and no lateral nodes enlargement); extramural vascular invasion but not larger than 7 mm in the largest dimension; M0.
  • Operable patient
  • Patient having read the information note and having signed the informed consent
  • Follow-up possible

Who cannot join

  • Inoperable patient
  • cT1, cT3d, large T4, tumour ≥5cm or ≥50 of rectal circumferential extent
  • Enlargement of lateral nodes or any node ≥8 mm in diameter
  • Patient presenting metastasis at diagnosis
  • Previous pelvic irradiation
  • Simultaneous progressive another cancer
  • Close follow-up uncertain.

Trial locations and contacts

1 site in 1 country.

Krzsztof Bujko, Prof. contact

+48 601 20 74 66

krzysztof.bujko@pib-nio.pl

Poland1 site, 1 recruiting

  • M. Skłodowska-Curie National Research Institute of Oncology

    Warsaw, 02-781

    Krzysztof Bujko, Prof., +48 601 20 74 66, krzysztof.bujko@pib-nio.pl

    Recruiting

Other trials in Poland

About this study

Official title: Radio(Chemo)Therapy Dose Escalation in Non-operative Management for Rectal Cancer: A Prospective NOM-3 Observational Study

The investigators propose to conduct an observational study on consecutive patients with low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal circumferential extent. The aim of this study is to test a hypothesis that escalation of either radiation or chemotherapy dose of the routine preoperative radio(chemo)therapy leads to an increase of clinical complete response rate. The planned sample size of 23 patients was calculated based on the assumption that clinical complete response rate after routine preoperative radio(chemo)therapy is 34% [1] and expected rate after radio(chemo)therapy dose escalation is 75% [2-4]. An endorectal high dose rate iridium brachytherapy boost (2 fractions of 10 Gy) will be added after the routine preoperative treatment consisted of external beam radiotherapy (5 × 5 Gy) combined with sequential 3 cycles of consolidation FOLFOX4. However, for patients with involvement of the anal canal, additional 3 cycles of consolidation FOLFOX4 (6 cycles in total) will be added instead of brachytherapy boost to avoid severe post-radiation toxicity.

Conditions
Rectal Cancer
Being tested
Radiotherapy boost, Additional consolidation chemotherapy
Keywords
Rectal cancer, Non-operative management
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • Radiotherapy boostRadiation

    Additional endorectal high rate irydium brachytherapy boost, 2 fractions of 10 Gy each.

  • Additional consolidation chemotherapyDrug

    Three additional cycles of 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4) consolidation chemotherapy

Study groups in NCT05241574
Study groupRoleWhat they receive
radiotherapy dose escalationExperimentalAdditional two fractions of endorectal high dose rate iridium brachytherapy boost, 10 Gy each.
Receives: Radiation: Radiotherapy boost
chemotherapy dose escalationExperimentalAdditional three cycles of consolidation chemotherapy consisted of 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4).
Receives: Drug: Additional consolidation chemotherapy

What is being measured

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

  1. Rate of patients with clinical complete response.

    Clinical complete response will be assessed by digital rectal examination, endoscopy and MRI. The analysis will take place 6 months after the start of treatment of a last enrolled patient.

    Measured: 15 weeks from the radiation start

Secondary outcomes (3)

  1. Regrowth rate.

    Regrowth rate will be accessed at 2 years in patients undergoing watch-and-wait. The analysis will take place 12 months after the start of treatment of a last enrolled patient.

    Measured: From 12 months to 26 months from the radiation start.

  2. Anorectal function.

    Anorectal function will be assessed by LARS scale before treatment and one year after the radiation start.

    Measured: One year after the radiation start.

  3. Acute and late toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.

    Acute and late toxicity will be assessed by CTCAE v.5 scale.

    Measured: From 12 months to 26 months from the radiation start.

Timeline

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

  1. First posted15 Feb 2022
  2. Study start3 Aug 2021
  3. Primary completionOct 2023 (estimated)
  4. Study completionOct 2023 (estimated)

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
Non-randomised
Intervention model
Sequential
Model description
A dose escalation study, either radiotherapy dose escalation or chemotherapy dose escalation.
Masking
None (open label)
Enrolment
23 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05241574
Sponsor's protocol ID
NOM-3
Status last verified
Feb 2022
First submitted
25 Jan 2022
Last updated
15 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Jankowski M, Pietrzak L, Rupinski M, Michalski W, Holdakowska A, Paciorek K, Rutkowski A, Olesinski T, Cencelewicz A, Szczepkowski M, Zegarski W, Reszke J, Richter P, Wawok P, Malecki K, Bebenek M, Szelachowska J, Mazurek M, Gisterek I, Polkowski W, Jankiewicz M, Stylinski R, Socha J, Bujko K; Polish Colorectal Study Group. Watch-and-wait strategy in rectal cancer: Is there a tumour size limit? Results from two pooled prospective studies. Radiother Oncol. 2021 Jul;160:229-235. doi: 10.1016/j.radonc.2021.05.014. Epub 2021 May 21.

    PubMed 34023328

  • Garant A, Magnan S, Devic S, Martin AG, Boutros M, Vasilevsky CA, Ferland S, Bujold A, DesGroseilliers S, Sebajang H, Richard C, Vuong T. Image Guided Adaptive Endorectal Brachytherapy in the Nonoperative Management of Patients With Rectal Cancer. Int J Radiat Oncol Biol Phys. 2019 Dec 1;105(5):1005-1011. doi: 10.1016/j.ijrobp.2019.08.042. Epub 2019 Aug 30.

    PubMed 31476417

  • Rijkmans EC, Cats A, Nout RA, van den Bongard DHJG, Ketelaars M, Buijsen J, Rozema T, Franssen JH, Velema LA, van Triest B, Marijnen CAM. Endorectal Brachytherapy Boost After External Beam Radiation Therapy in Elderly or Medically Inoperable Patients With Rectal Cancer: Primary Outcomes of the Phase 1 HERBERT Study. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):908-917. doi: 10.1016/j.ijrobp.2017.01.033. Epub 2017 Jan 20.

    PubMed 28366579

  • 4. Garcia-Aguilar J, Patil S, Kim JK, et al. Preliminary results of the organ preservation of rectal adenocarcinoma (OPRA) trial. J Clin Oncol 38: 2020 (suppl; abstr 4008).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy boost and Additional consolidation chemotherapy in people with Rectal Cancer, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

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 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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?

Results are not available in the source record.

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

Contact Krzsztof Bujko, Prof. (+48 601 20 74 66, krzysztof.bujko@pib-nio.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients with clinical complete response. (time frame: 15 weeks from the radiation start). 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 NCT05241574, which also lists 4 linked publications.

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 15 Feb 2022.

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