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Rectal CancerPhase 2K-BOOSTNCT07622017

KORTUC (KRC-01) Plus Radiotherapy for Organ Preservation in Rectal Cancer

A Phase 2 study testing KRC-01 (KORTUC), Radiotherapy and Capecitabine in people with Rectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rectal Cancer
What is being tested?
KRC-01 (KORTUC), Radiotherapy and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesFrance
Study dates
Jul 2026to Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • At least one of the following criteria: cT4a, cT4b, presence of extramural invasion (EMVI+), cN2, involvement of the mesorectal fascia (MFI+), involvement of lateral lymph nodes (lat LN+)
  • Adenocarcinoma located with a lower border less than 15 cm from the anal margin
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  • Primary resection without chemoradiotherapy is unlikely to achieve clear margins.
  • Tumor lesion must be mesurable by endoscopic visual assessment
  • Target tumor is accessible for intratumoral injections.
  • Intention to undergo treatment including 5 Fu based chemoradiotherapy and CAPOX (6 cycles) or FOLFOX (9 cycles)
  • Life expectancy > 6 months
  • Acceptable organ functions, as evidenced by the following laboratory data:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×upper limit of normal (ULN).
  • Total serum bilirubin ≤ 1.5×ULN.
  • Absolute neutrophil count (ANC): ≥ 1500 cells/mm³.
  • Platelet count: ≥ 100,000 cells/mm³.
  • Hemoglobin: ≥ 9.0 g/dL.
  • Serum creatinine levels ≤ 1.5×ULN, or calculated (by Cockcroft-Gault formula or other accepted formula) and measured creatinine clearance ≥50 mL/min.
  • Amylase and lipase ≤ 1.5xULN.
  • Adequate blood coagulation function as evidenced by an International Normalized Ratio (INR) ≤ 1.5.
  • Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 12 hours prior to the administration of the first study treatment.
  • Female subjects of childbearing potential should be willing to use a highly effective method of contraception or be surgically sterile or abstain from heterosexual activity during the study treatment and for at least 15 months after the last dose of oxaliplatin and 6 months after the last dose of capecitabine or 5-fluorouracil, whichever period is longer.. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year. cf. section 7.8 "Pregnancy and contraception") Note: A woman is considered of childbearing potential following menarche and until becoming post-menopausal (≥ 12 months of non-therapy-induced amenorrhea) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral oophorectomy, and bilateral salpingectomy. A "highly effective" birth control method is one which can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include: combined (estrogen and progestogen containing) hormonal contraception; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (on the understanding that this is the only partner during the whole study duration), and sexual abstinence during the entire period of risk associated with study treatment. To prevent the risk of interaction between the study drug and hormonal contraceptives, hormonal contraceptives should be supplemented with a barrier method (preferably male condom). Following methods are considered as unacceptable methods (non-exhaustive list): periodic abstinence (calendar, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus).
  • Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy until at least 12 months after the last dose of oxaliplatin and 3 months after the last dose of capecitabine or 5-fluorouracil, whichever period is longer.
  • Also, it is recommended that women of childbearing potential partner use a highly effective method of contraception.
  • Patients who either do not consent to a tumor biopsy or do not have accessible lesions will not be eligible.
  • Patients should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
  • Patient should be able and willing to comply with study visits and procedures as per protocol.
  • Patient must be affiliated to a social security system or beneficiary of the same.

Who cannot join

  • 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.).
  • Participation in another clinical study with an investigational product during the last 3 months.
  • Prior rectal surgery.
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  • Prior investigational treatment for rectal cancer.
  • Patients with known high microsatellite instability (MSI-H) or mismatch repair deficient (dMMR) tumors are not eligible, as these patients may benefit from standard-of-care immunotherapy.
  • High medical risk because of systemic diseases (e.g., uncontrolled infections, uncontrolled diabetes) in addition to the qualifying disease under study. Patients must not have any uncontrolled concurrent illness including, but not limited to, severe active or uncontrolled infection, symptomatic congestive heart failure, unstable, angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients receiving therapeutic anticoagulation are not eligible. Prophylactic anticoagulation at low dose (e.g., thromboprophylaxis) may be allowed at the investigator's discretion, provided that the bleeding risk is considered minimal.
  • Patients receiving concomitant treatment with brivudine or who have received brivudine within the previous 4 weeks.
  • Peripheral sensory neuropathy grade ≥2 (for the future administration of oxaliplatin)
  • Dihydropyrimidine deshydrogenase (DPD) deficiency. DPD status must be assessed prior to inclusion, and uracilemia testing is mandatory before initiation of fluorouracil-based treatment. Patients with unknown DPD status are not eligible.
  • Concomitant medications/comorbidities that may prevent the patient from receiving study treatments,
  • Contraindication to fluoropyrimidines or oxaliplatin and capecitabin as mentioned in the SMPC of investigational medicinal products: FOLFOX is contraindicated in patients with known hypersensitivity to 5-fluorouracil, oxaliplatin, leucovorin, or other platinum compounds; in those with severe renal impairment (CrCl <30 mL/min), significant bone marrow suppression, uncontrolled infections, or pre-existing grade ≥2 peripheral neuropathy. It is also contraindicated in individuals with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency due to the risk of severe 5-FU toxicity, as well as in cases of severe hepatic dysfunction, pregnancy, and breastfeeding. Caution is advised in patients with poor performance status (ECOG ≥3).
  • Yellow fever vaccine and live attenuated vaccines are contraindicated due to the risk of severe vaccine-induced infection. Note: The currently authorized COVID-19 vaccines are not live vaccines and therefore can be safely administered.
  • Known history of human immunodeficiency virus (HIV) infection or seropositive results consistent with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
  • Pregnant or breastfeeding women or intending to become pregnant during the clinical investigation.
  • Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Deutsch, MD, PhD contact

(+33)142116573

Eric.DEUTSCH@gustaveroussy.fr

France2 sites

  • Institut Bergonié

    Bordeaux, 33000

    Nicolas Magne, +33 (0)5 56 33 33 33, n.magne@bordeaux.unicancer.fr

    a.italiano@bordeaux.unicancer.fr

  • Gustave Roussy

    Villejuif, Val de Marne, 94800

    Eric Deutsch, MD, PhD, +33(0)142116573, Eric.DEUTSCH@gustaveroussy.fr

Other trials in France

About this study

Official title: Phase II Clinical Trial of KORTUC (KRC-01) Combined With Radiotherapy for Locally Advanced Rectal Cancer: Towards a New Organ Preservation Approach

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.

Read more

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.

Conditions
Rectal Cancer
Being tested
KRC-01 (KORTUC), Radiotherapy, Capecitabine, CAPOX, FOLFOX
Keywords
Intratumoral, chemoradiotherapy, advanced rectal cancer, Organ Preservation
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KRC-01 (KORTUC)Drug

    Intratumoral injections administered before radiotherapy.

  • RadiotherapyRadiation

    Standard radiotherapy administered with chemotherapy.

  • CapecitabineDrug

    Standard chemotherapy regimen (capecitabine) administered with radiotherapy.

  • CAPOXDrug

    Standard chemotherapy regimen (capecitabine and oxaliplatin), after chemoradiotherapy

  • FOLFOXDrug

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

  • Optionnal TMEProcedure or surgery

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

Study groups in NCT07622017
Study groupRoleWhat they receive
Intratumoral KRC-01 injections combined with standard chemoradiotherapyExperimentalParticipants receive intratumoral KRC-01 injections (8 injections) combined with standard long-course chemoradiotherapy (radiotherapy: 50 Gy in 25 fractions plus capecitabine 825 mg/m² orally twice daily for 5 weeks) and consolidation chemotherapy with CAPOX or FOLFOX according to investigator decision and institutional practice. Surgery with total mesorectal excision (TME) may be performed depending on tumor response and multidisciplinary team assessment.
Receives: Drug: KRC-01 (KORTUC); Radiation: Radiotherapy; Drug: Capecitabine; Drug: CAPOX; Drug: FOLFOX; Procedure: Optionnal TME

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 24

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: Up to 24 months

  3. Overall Survival (OS)

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

    Measured: 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

    Measured: From first study treatment administration up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionJan 2029 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07622017
Sponsor's protocol ID
2025-524378-40-00
Other IDs
CSET number 2025/4237, 2025
Acronym
K-BOOST
Status last verified
May 2026
First submitted
27 May 2026
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KRC-01 (KORTUC), Radiotherapy and Capecitabine in people with Rectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Deutsch, MD, PhD ((+33)142116573, Eric.DEUTSCH@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Complete Response (cCR) Rate at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07622017.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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