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Rectal Neoplasms MalignantPhase 3RuCorT-02NCT04134897

Neoadjuvant Chemotherapy in Patients With Moderate Risk Mid Rectal Cancer

A Phase 3 study testing Capecitabine, Oxaliplatin and Radiotherapy in people with Rectal Neoplasms Malignant and Rectum Carcinoma, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Capecitabine, Oxaliplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteRussia
Study dates
14 Oct 2019to Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent
  • Histologically verified colon rectal adenocarcinoma
  • сT3c-T3dN0-1M0, cT1-T3dN2M0. cancer of the middle rectum (based on pelvic MRI)
  • Tumor more than 2 mm from mesorectal fascia (based on pelvic MRI)
  • Eastern Cooperative Oncology Group (ECOG) status 0-2
  • Haemoglobin (HGB) > 90 g/L
Show all 9Show fewer
  • Platelet Count (PLT) > 120x10*9/L
  • Serum creatinine < 150 µmol/L
  • Total bilirubin < 25 µmol/L

Who cannot join

  • inability to obtain informed consent
  • distant metastases
  • synchronous or metachronous tumors
  • previous chemotherapy or radiotherapy
  • clinically significant cardiovascular disorders (myocardial infarction < 6 months before visit, stroke < < 6 months before visit, instable angina < 3 months before visit, arrhythmia, uncontrolled hypertension > 160/100 mm hg
  • clinically significant neurological disorders
Show all 17Show fewer
  • previous neuropathy 2 or higher
  • current infection or heavy systemic disease
  • pregnancy, breastfeeding
  • ulcerative colitis
  • individual intolerance to treatment components
  • proven dihydropyrimidine dehydrogenase (DPD) deficiency
  • participation in other clinical trials
  • psychiatric disorders, which render patient unable to follow instructions or understand his/her condition
  • technical inability to perform pelvic MRI
  • inability of long-term followup of the patient
  • HIV

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • N.N.Blokhin Russian Cancer Research Center

    Moscow, 115478

Other trials in Russia

About this study

Official title: A Multicenter Prospective Phase III Clinical Trial of Neoadjuvant CapOx in Patients With Intermediate Risk CRM-negative Middle Rectal Cancer

The purpose of this study is to determine whether 3 months of neoadjuvant CapOx is non-inferior to neoadjuvant radiotherapy in patients with moderate risk CRM"-" mid rectal cancer.

Read the detailed description

This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to 5x5 Gy neoadjuvant radiotherapy in moderate risk CRM-negative rectal cancer patients. This is a prospective multicenter open-label non-inferiority randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 4 cycles of neoadjuvant CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, surgery and 4 cycles of adjuvant CapOx chemotherapy or 5x5 Gy radiotherapy, surgery and 8 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on сN stage and clinical center. Patients with сT3c-T3dN0-1M0, cT1-T3dN2M0 cancer in the middle rectum are included. Chemoradiotherapy (50 Gy with concomitant capecitabine 825 mg/m2 per os bid on radiation days) will be performed for patients with tumor progression after neoadjuvant chemotherapy. The main hypothesis is that the 2-year local recurrence rate is non-inferior after neoadjuvant chemotherapy and neoadjuvant radiotherapy in moderate risk mid rectal cancer patients. The target accrual is 158 patients in each treatment arm (including 10% potential data loss) based on non-recurrence rate of 98% in investigated and 96% in the control group with a non-inferiority margin of 3%, α=0,05, power 80%. An interim analysis is planned after 50% of the patients will reach a 2-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.

Being tested
Capecitabine, Oxaliplatin, Radiotherapy, Rectal cancer surgery
Keywords
rectal cancer, neoadjuvant chemotherapy, neoadjuvant radiotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • CapecitabineDrug

    Also called Xeloda

    2000 mg/m2, bid, per os, days 1-14, 4 cycles

  • OxaliplatinDrug

    130 mg/m2 iv day 1, 4 cycles

  • CapecitabineDrug

    Also called Xeloda

    825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)

  • RadiotherapyRadiation

    Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor

  • Rectal cancer surgeryProcedure or surgery

    Laparoscopic or open total mesorectal excision

  • RadiotherapyRadiation

    Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions

Study groups in NCT04134897
Study groupRoleWhat they receive
Neoadjuvant chemotherapyExperimentalPatients will receive 4 cycles of neoadjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks). In case of partial response or stable disease (based on pelvic MRI) patients proceed to surgery within 2 weeks. In case of disease progression patients receive 50 Gy pelvic chemoradiotherapy with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 8-10 weeks. After surgery patients receive 4 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy; Procedure: Rectal cancer surgery
Neoadjuvant radiotherapyActive comparatorPatients will receive 5x5 Gy radiotherapy and then surgery following 6-8 weeks. After surgery patients receive 8 cycles of adjuvant CapOx chemotherapy (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 bid per os days 1-14 every 3 weeks).
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Procedure: Rectal cancer surgery; Radiation: Radiotherapy

What is being measured

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

  1. 2-year local recurrence rate

    Measured: 2 years

Secondary outcomes (8)

  1. Adjuvant chemotherapy compliance

    Proportion of patients who receive a complete course of adjuvant chemotherapy

    Measured: 6 months

  2. Acute chemotherapy toxicity

    Toxicity measured according to NCI-CTCAE v.5.0

    Measured: 6 months

  3. pathologic complete response rate (pCR)

    Measured: 1 month

  4. 2-year overall survival

    Measured: 2 years

  5. 2-year disease-free survival

    Measured: 2 years

  6. Operative morbidity

    Morbidity measured according to Clavien-Dindo classification

    Measured: 30 days

  7. Neoadjuvant chemotherapy disease progression rate

    Proportion of patients with disease progression during neoadjuvant chemotherapy

    Measured: 3 months

  8. Preoperative tumor-associated complications rate

    The rate of tumor-associated complications (bowel obastruction, bleeding etc) during neoadjuvant chemotherapy

    Measured: 3 months

Timeline

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

  1. First posted22 Oct 2019
  2. Study start14 Oct 2019
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2024 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04134897
Sponsor's protocol ID
RuCorT-02
Acronym
RuCorT-02
Status last verified
Feb 2021
First submitted
19 Oct 2019
Last updated
9 Feb 2021
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 3 study testing Capecitabine, Oxaliplatin and Radiotherapy in people with Rectal Neoplasms Malignant and Rectum Carcinoma, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.

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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year local recurrence rate (time frame: 2 years). 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 NCT04134897.

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 9 Feb 2021.

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