KORTUC (KRC-01) Plus Radiotherapy for Organ Preservation in Rectal Cancer
ConditionRectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGustave Roussy, Cancer Campus, Grand Paris
About this trial
This phase II clinical trial is evaluating whether adding KRC-01 injections to standard chemoradiotherapy may improve treatment outcomes in patients with locally advanced rectal cancer without metastases.
KRC-01 is an investigational product designed to improve the effectiveness of radiotherapy by increasing oxygen levels inside tumors, which may help radiation work better. KRC-01 contains hydrogen peroxide and sodium hyaluronate and is injected directly into the tumor before radiotherapy sessions.
Previous clinical experience in Japan, including studies in several types of cancer, suggested that this approach may improve tumor oxygenation and enhance the effect of radiotherapy.
The main objective of the K-BOOST study is to evaluate how many patients achieve a complete clinical response after treatment with chemoradiotherapy combined with intratumoral KRC-01 injections, potentially allowing some patients to avoid surgery. Surgery may still be recommended depending on the individual response to treatment.
Approximately 24 patients will participate in this multicenter French study. The experimental treatment period lasts approximately 26 weeks, and participants will be followed for up to 2 years.
Eligibility criteria
Qualifiers
Males and females ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Histopathologically confirmed locally advanced rectal adenocarcinoma, stage III (high risk)
No evidence of metastatic disease on computed tomography (chest and abdomen), including resectable metastases. (M0, and no oligometastases)
Disqualifiers
Patients not deemed fit for radiotherapy or preexisting condition which would deter radiotherapy, e.g., fistulas, severe ulcerative colitis (including subjects currently taking sulphasalazine), active Crohn's disease, prior adhesions.
Patients with hypokalemia below the lower limit of normal, hypomagnesemia, hypocalcemia, or QT/QTc interval >450 msec in males or >470 msec in females at inclusion are not eligible.
Any Previous radiotherapy in the pelvic region.
Contraindications to MRI (e.g., subjects with pacemakers, claustrophobia, excessive weight, etc.).
Trial design
Treatments tested in this trial
- KRC-01 (KORTUC)
- Radiotherapy
- Capecitabine
- CAPOX
- FOLFOX
- Optionnal TME
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Lead sponsor
Kortuc, Inc.
Collaborator
Source ClinicalTrials.gov