Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Locally Advanced Rectal Cancer Clinical Trial

— ICONA  

Official title:

Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Localy Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054959
• Other study ID #: KME 0120-214/2021/3
• Status: Recruiting
• Phase: Phase 2
• Start date: June 24, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2021
• Source: Institute of Oncology Ljubljana
• Contact: Vaneja Velenik, PhD
• Phone: +386 15879297
• Email: vvelenik[@]onko-i.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to identify the most promising sequence of modalities in total neoadjuvant treatment of localy advanced rectal cancer with high risk of recurrence

Description:

International recommendations for the treatment of LARC with a high risk of disease recurrence are inconsistent, regarding TNT. In Germain randomised study more pCR were achieved with consolidation chemotherapy. We will compare our standard approach (induction plus consolidation CT) with consolidation CT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:- histologically proven rectal adenocarcinoma

• no distant metastases on CT scan (M0 disease)

• at least one high risk factor for disease recurrence identified on MR imaging:

• T4 tumor (cT4)

• N2 disease (cN2)

• extramural venous invasion (cEMVI+)

• positive lateral lymph nodes

• distance of tumor to mesorectal fascia or positive lymph nodes is 1 mm or less (cMRF+)

• capacity for informed consent

• willingness to attend regular check-ups during and after treatment

Exclusion Criteria:history of previous irradiation in the pelvic area

• absolute contraindications for MR imaging

• distant metastases cannot be reliably excluded

• synchronous cancer

• chronic inflammatory bowel disease

Related Conditions & MeSH terms

• Locally Advanced Rectal Cancer
• Rectal Neoplasms
• Recurrence

Intervention

Other:
• consolidation chemotherapy
6 cycles CAPOX after chemoradiotherapy
• induction chemotherapy
4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy

Locations

Country	Name	City	State
Slovenia	Institute of Oncology	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Oncology Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (6)

But-Hadzic J, Anderluh F, Brecelj E, Edhemovic I, Secerov-Ermenc A, Hudej R, Jeromen A, Kozelj M, Krebs B, Oblak I, Omejc M, Vogrin A, Velenik V. Acute Toxicity and Tumor Response in Locally Advanced Rectal Cancer After Preoperative Chemoradiation Therapy With Shortening of the Overall Treatment Time Using Intensity-Modulated Radiation Therapy With Simultaneous Integrated Boost: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Dec 1;96(5):1003-1010. doi: 10.1016/j.ijrobp.2016.08.031. Epub 2016 Aug 31. — View Citation

Cercek A, Goodman KA, Hajj C, Weisberger E, Segal NH, Reidy-Lagunes DL, Stadler ZK, Wu AJ, Weiser MR, Paty PB, Guillem JG, Nash GM, Temple LK, Garcia-Aguilar J, Saltz LB. Neoadjuvant chemotherapy first, followed by chemoradiation and then surgery, in the management of locally advanced rectal cancer. J Natl Compr Canc Netw. 2014 Apr;12(4):513-9. — View Citation

Fokas E, Allgäuer M, Polat B, Klautke G, Grabenbauer GG, Fietkau R, Kuhnt T, Staib L, Brunner T, Grosu AL, Schmiegel W, Jacobasch L, Weitz J, Folprecht G, Schlenska-Lange A, Flentje M, Germer CT, Grützmann R, Schwarzbach M, Paolucci V, Bechstein WO, Friede T, Ghadimi M, Hofheinz RD, Rödel C; German Rectal Cancer Study Group. Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12. J Clin Oncol. 2019 Dec 1;37(34):3212-3222. doi: 10.1200/JCO.19.00308. Epub 2019 May 31. — View Citation

Golo D, But-Hadzic J, Anderluh F, Brecelj E, Edhemovic I, Jeromen A, Omejc M, Oblak I, Secerov-Ermenc A, Velenik V. Induction chemotherapy, chemoradiotherapy and consolidation chemotherapy in preoperative treatment of rectal cancer - long-term results of phase II OIGIT-01 Trial. Radiol Oncol. 2018 Sep 11;52(3):267-274. doi: 10.2478/raon-2018-0028. — View Citation

Tuta M, Boc N, Brecelj E, Omejc M, Anderluh F, Ermenc AS, Peressutti AJ, Oblak I, Krebs B, Velenik V. Total neoadjuvant treatment of locally advanced rectal cancer with high risk factors in Slovenia. Radiol Oncol. 2019 Oct 25;53(4):465-472. doi: 10.2478/raon-2019-0046. — View Citation

Tuta M, Boc N, Brecelj E, Peternel M, Velenik V. Total neoadjuvant therapy vs standard therapy of locally advanced rectal cancer with high-risk factors for failure. World J Gastrointest Oncol. 2021 Feb 15;13(2):119-130. doi: 10.4251/wjgo.v13.i2.119. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate	The proportion of complete responses will be defined as the sum of the proportions of pCR in operated patients and cCR in non-operated patients.	2 weeks after completiton of TNT
Secondary	Overall survival	time from randomization to death	after 3 years of follow-up
Secondary	Survival without recurrence of the disease	time from the end of treatment (in the case of cCR) or from radical surgery to death or recurrence of the disease - whichever comes first.	after 3 years of follow-up
Secondary	Disease free survival	the time from the end of treatment (in the case of cCR) or surgery to the recurrence of disease, the onset of new cancer, death from cancer or other causes	after 3 years of follow-up
Secondary	local control	the time from the end of the treatment (in the case of cCR) or surgery to local recurrence	after 3 years of follow-up