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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • KRC-01 (KORTUC)

    Drug

    Intratumoral injections administered before radiotherapy.

  • Radiotherapy

    Radiation

    Standard radiotherapy administered with chemotherapy.

  • Capecitabine

    Drug

    Standard chemotherapy regimen (capecitabine) administered with radiotherapy.

  • CAPOX

    Drug

    Standard chemotherapy regimen (capecitabine and oxaliplatin), after chemoradiotherapy

  • FOLFOX

    Drug

    Standard chemotherapy regimen (5-fluorouracil, leucovorin, and oxaliplatin), after chemoradiotherapy

  • Optionnal TME

    Procedure/Surgery

    Surgery with total mesorectal excision (TME) may be performed depending on tumor response and multidisciplinary team assessment

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Intratumoral KRC-01 injections combined with standard chemoradiotherapyExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Clinical Complete Response (cCR) Rate at Week 24

Clinical complete response (cCR) rate is defined as the proportion of patients with no clinical, rectoscopic, or radiographic evidence of disease at Week 24 after treatment. Patients with at least one missing clinical, rectoscopic, or radiographic evaluation, or lost to follow-up before Week 25, will be considered non-responders.

Time frame
Week 24

Secondary outcomes

1

Pathological Complete Response (pCR) Rate

Pathological complete response (pCR) rate will be assessed in patients undergoing total mesorectal excision (TME) surgery and defined as the proportion of patients with no residual viable tumor identified in the surgical specimen.

Time frame
At time of surgery (approximately Week 26)
2

Progression-Free Survival (PFS)

Progression-free survival (PFS) is defined as the time from study inclusion to disease progression or death from any cause, whichever occurs first.

Time frame
Up to 24 months
3

Overall Survival (OS)

Overall survival (OS) is defined as the time from study inclusion to death from any cause.

Time frame
Up to 24 months
4

Incidence of Adverse Events

Incidence, nature, and severity of adverse events (AEs) will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) and summarized by system organ class, preferred term, and worst grade experienced

Time frame
From first study treatment administration up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gustave Roussy, Cancer Campus, Grand Paris

Lead sponsor

Kortuc, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: