Planned Non-operative Management for Rectal Cancer

NCT05241574 | Unknown Phase 2

• 1 other identifier: NOM-3
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Rectal cancer; Non-operative management

Outcome Measures

Primary Outcomes (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.

  15 weeks from the radiation start

Secondary Outcomes (3)

• Regrowth rate.

  From 12 months to 26 months from the radiation start.

• Anorectal function.

  One year after the radiation start.

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

  From 12 months to 26 months from the radiation start.

Study Arms (2)

radiotherapy dose escalation

EXPERIMENTAL

Additional two fractions of endorectal high dose rate iridium brachytherapy boost, 10 Gy each.

Radiation: Radiotherapy boost

chemotherapy dose escalation

EXPERIMENTAL

Additional three cycles of consolidation chemotherapy consisted of 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4).

Drug: Additional consolidation chemotherapy

Interventions

Radiotherapy boost RADIATION

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

radiotherapy dose escalation

Additional consolidation chemotherapy DRUG

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

chemotherapy dose escalation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

M. Skłodowska-Curie National Research Institute of Oncology

Warsaw, 02-781, Poland

RECRUITING

Related Publications (4)

• 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.

  PMID: 34023328 BACKGROUND

• 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.

  PMID: 31476417 BACKGROUND

• 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.

  PMID: 28366579 BACKGROUND

• 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).

  BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Paulina Śliwka, MS

  Maria Skłodowska-Curie National Research Institute of Oncology

  STUDY DIRECTOR

Central Study Contacts

Krzsztof Bujko, Prof.

CONTACT

+48 601 20 74 66; krzysztof.bujko@pib-nio.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: A dose escalation study, either radiotherapy dose escalation or chemotherapy dose escalation.

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 15, 2022
• Study Start: August 3, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)