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Rectal Neoplasms MalignantPhase 3RuCorT-01NCT04103697

Neoadjuvant Chemotherapy in Patients With Intermediate Risk Upper and 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 The sponsor has not verified this record for over two years, so it may be out of date.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 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper rectal cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Capecitabine, Oxaliplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
560 participants
Where
1 siteRussia
Study dates
1 Aug 2019to Aug 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent
  • Histologically verified colon rectal adenocarcinoma
  • cT3-4aN1-2M0 cancer of the upper rectum or сТ2-Т3bN1M0 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
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  • 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 16Show 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

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 Chemotherapy in Patients With Intermediate Risk Middle and Upper Rectal Cancer

The purpose of this study is to determine whether 4 cycles of neoadjuvant CapOx chemotherapy is more effective than the upfront surgery in patients with intermediate risk CRM"-" mid and upper rectal cancer.

Read the detailed description

This trial aims to investigate the efficacy of neoadjuvant chemotherapy compared to upfront surgery in intermediate risk rectal cancer patients. This is a prospective multicenter open-label 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 and surgery or surgery alone. A stratification will be performed based on N stage, tumor location in the middle or upper rectum and clinical center. Patients with cT3-4aN1-2M0, T4aN0M0 cancer in the upper rectum and сТ2-Т3bN1M0 (based on preoperative MRI) cancer in the middle rectum are included. All patients are potential candidates for adjuvant chemotherapy, according to preoperative staging. 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 decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage in both treatment arms, according to actual treatment guidelines. The target accrual is 280 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 10% 3-yr disease-free survival (75% vs 85%), α=0,05, power 80% in the experimental arm. An interim analysis is planned after 50% of the patients will reach a 3-year followup. Pelvic Magnetic Resonance Imaging (MRI) is performed in all patients for staging before and after neoadjuvant chemotherapy and before surgery. Pelvic MRI isbject 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, mesorectal excision
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 partial or total mesorectal excision (based on exact tumor location and surgeons discretion)

Study groups in NCT04103697
Study groupRoleWhat they receive
4xCapOxExperimentalPatients 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. 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. The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy; Procedure: Rectal cancer surgery
SurgeryActive comparatorPatients will receive standard surgery for rectal cancer with partial or total mesorectal excision (based on exact tumor location and surgeons discretion). The decision to proceed with adjuvant chemotherapy postoperatively will be based on pTNM stage
Receives: Drug: Capecitabine; Drug: Oxaliplatin; Procedure: Rectal cancer surgery

What is being measured

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

  1. 3-year disease-free survival

    Measured: 3 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: 14 weeks

  3. pathologic complete response rate (pCR)

    Measured: 1 month

  4. local recurrence rate

    Measured: 3 years

  5. 3-year overall survival

    Measured: 3 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: 14 weeks

  8. Preoperative tumor-associated complications rate

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

    Measured: 14 weeks

Timeline

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

  1. First posted25 Sep 2019
  2. Study start1 Aug 2019
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 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
560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04103697
Sponsor's protocol ID
RuCorT-01
Acronym
RuCorT-01
Status last verified
Feb 2021
First submitted
24 Sep 2019
Last updated
9 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
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 16 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?

3-year disease-free survival (time frame: 3 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 NCT04103697.

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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