NCT03729687: LARCT-US

Short Course Radiation Therapy Followed by Pre-operative Chemotherapy and Surgery in High-risk Rectal Cancer

Status unknown Phase 2 Last updated 30 November 2023

What this trial tests

Phase 2 trial testing radiotherapy, capecitabine, oxaliplatin in Rectal Cancer in 280 participants. Status unknown.

Timeline

4 July 2016

Primary endpoint
30 May 2020

30 June 2025

Quick facts

Lead sponsor	Uppsala University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	280
Start date	4 July 2016
Primary completion	30 May 2020
Estimated completion	30 June 2025
Sites	1 location across Sweden

Drugs / interventions tested

• radiotherapy, capecitabine, oxaliplatin

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

Uppsala University

Who can join

18 and older, any sex, with Rectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with a primary rectal cancer without detectable distant metastasis who after locoregional therapy only, meaning preoperative radio(chemo)therapy plus surgery have at least a 40% risk of not having a CRM negative resection or a recurrence, local or distant, within three years will be treated with the short course 5 x 5 Gy radiation scheme followed by four cycles of combination chemotherapy (capecitabine and oxaliplatin) and TME surgery

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recurrence Risk after Radical Colorectal Cancer Surgery-Less Than before, But How High Is It?
   Osterman E, Hammarström K, Imam I, Osterlund E, et al · · 2020 · cited 49× · PMID 33182510 · DOI 10.3390/cancers12113308
2. A Comprehensive Evaluation of Associations Between Routinely Collected Staging Information and The Response to (Chemo)Radiotherapy in Rectal Cancer.
   Hammarström K, Imam I, Mezheyeuski A, Ekström J, et al · · 2020 · cited 29× · PMID 33375133 · DOI 10.3390/cancers13010016
3. Organ preservation following short-course radiotherapy for rectal cancer.
   Nilsson PJ, Ahlberg M, Kordnejad S, Holm T, et al · · 2021 · cited 20× · PMID 34686879 · DOI 10.1093/bjsopen/zrab093
4. Total neoadjuvant treatment using short-course radiotherapy and four CAPOX cycles in locally advanced rectal cancer with high-risk criteria for recurrence: a Swedish nationwide cohort study (LARCT-US).
   Glimelius B, Khan T, Adolfsson K, Angenete E, et al · · 2024 · cited 13× · PMID 39568777 · DOI 10.1016/j.eclinm.2024.102771
5. Associations between Response to Commonly Used Neo-Adjuvant Schedules in Rectal Cancer and Routinely Collected Clinical and Imaging Parameters.
   Karimi M, Osterlund P, Hammarström K, Imam I, et al · · 2022 · cited 6× · PMID 36551723 · DOI 10.3390/cancers14246238
6. Locoregional and systemic control after total neoadjuvant therapy with short-course radiotherapy for locally advanced rectal cancer: long-term outcomes from the LARCT-US study.
   Imam I, Nilsson PJ, Khan T, Angenete E, et al · · 2026 · cited 1× · PMID 41709532 · DOI 10.1093/bjs/znag014
7. Recent advances in rectal cancer treatment – are we on the right track?
   · 2024