Planned Non-operative Management for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05241574
• Other study ID #: NOM-3
• Status: Recruiting
• Phase: Phase 2
• Start date: August 3, 2021
• Est. completion date: October 2023

Study information

• Verified date: February 2022
• Source: Maria Sklodowska-Curie National Research Institute of Oncology
• Contact: Krzsztof Bujko, Prof.
• Phone: +48 601 20 74 66
• Email: krzysztof.bujko[@]pib-nio.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. 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.

2. Operable patient

3. Patient having read the information note and having signed the informed consent

4. Follow-up possible

Exclusion Criteria:

1. Inoperable patient

2. cT1, cT3d, large T4, tumour =5cm or =50 of rectal circumferential extent

3. Enlargement of lateral nodes or any node =8 mm in diameter

4. Patient presenting metastasis at diagnosis

5. Previous pelvic irradiation

6. Simultaneous progressive another cancer

7. Close follow-up uncertain.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Radiotherapy boost
Additional endorectal high rate irydium brachytherapy boost, 2 fractions of 10 Gy each.

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

Locations

Country	Name	City	State
Poland	M. Sklodowska-Curie National Research Institute of Oncology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie National Research Institute of Oncology

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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).

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	From 12 months to 26 months from the radiation start.
Secondary	Anorectal function.	Anorectal function will be assessed by LARS scale before treatment and one year after the radiation start.	One year after the radiation start.
Secondary	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.	From 12 months to 26 months from the radiation start.