Rectal Neoplasms MalignantPhase 3RuCorT-03NCT04135313
Induction and Consolidation Chemotherapy in Patients With Locally Advanced CRM-positive 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.
Trial summary
The purpose of this study is to determine whether the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms Malignant, Rectum Carcinoma, Rectal Cancer
- What is being tested?
- Capecitabine, Oxaliplatin and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteRussia
- Study dates
- 20 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 0-10 cm above the anal verge
- No distant metastases
- Circumferential resection margin (CRM) involvement (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
- cT2N0M0 rectal cancer
- 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
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- clinically significant neurological disorders
- 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.
About this study
Official title: Induction and Consolidation Chemotherapy in Locally Advanced Rectal Cancer Patients With Circumferential Resection Margin Involvement: a Multicenter Prospective Randomized Phase III Clinical Trial
The purpose of this study is to determine whether the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low rectal cancer.
Read the detailed description
This trial aims to investigate the efficacy of adding neoadjuvant induction and consolidation chemotherapy compared to standard chemoradiotherapy in locally advanced rectal cancer patients with circumferential resection margin involvement. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy OR chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), surgery (10-12 weeks following chemoradiotherapy) and 6 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on N stage, tumor location in the middle or low rectum and clinical center. Patients with middle or low rectal cancer without distant metastases, with involved circumferential resection margin (based on pretreatment MRI) will be included.
The target accrual is 270 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 12% 3-yr disease-free survival (60% vs 72%), 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 is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.
- Conditions
- Rectal Neoplasms Malignant, Rectum Carcinoma, Rectal Cancer
- Being tested
- Capecitabine, Oxaliplatin, Radiotherapy, Rectal cancer surgery
- Keywords
- rectal cancer, induction chemotherapy, consolidation chemotherapy, neoadjuvant chemotherapy
- 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
OxaliplatinDrug
130 mg/m2 iv day 1
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, 54 Gy on primary tumor in 2 Gy fractions
Rectal cancer surgeryProcedure or surgery
Laparoscopic or open total mesorectal excision or extralevator abdominoperineal resection
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Patients receive 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy; Procedure: Rectal cancer surgery |
| Chemoradiotherpy | Active comparator | Patients receive 54 Gy pelvic chemoradiotherapy in 2 Gy fractions with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 10-12 weeks. After surgery patients receive 6 cycles of adjuvant CapOx chemotherapy. Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy; Procedure: Rectal cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival
Measured: 3 years
Secondary outcomes (8)
Adjuvant chemotherapy compliance
Proportion of patients who receive a complete course of adjuvant chemotherapy
Measured: 6 months
Acute chemotherapy toxicity
Toxicity measured according to NCI-CTCAE v.5.0
Measured: 6 months
pathologic complete response rate (pCR)
Measured: 1 month
local recurrence rate
Measured: 3 years
3-year overall survival
Measured: 3 years
Operative morbidity
Morbidity measured according to Clavien-Dindo classification
Measured: 30 days
Preoperative tumor-associated complications rate
The rate of tumor-associated complications (bowel obstruction, bleeding etc) during neoadjuvant chemotherapy
Measured: 6 months
Sphincter preservation rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start20 Oct 2019
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neoplasms MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergey Gordeyev, Blokhin's Russian Cancer Research Center
- Investigators
- Zaman Z Mamedli, PhD, Principal investigator, N.N.Blokhin Russian Cancer Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135313
- Sponsor's protocol ID
- RuCorT-03
- Acronym
- RuCorT-03
- Status last verified
- Feb 2021
- First submitted
- 20 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction and Consolidation Chemotherapy in Locally Advanced Rectal Cancer Patients With Circumferential Resection Margin Involvement: a Multicenter Prospective Randomized Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT04135313
- Acronym / sponsor ID
- RuCorT-03 / RuCorT-03
- Conditions
- Rectal Neoplasms Malignant, Rectum Carcinoma, Rectal Cancer
- Keywords
- rectal cancer, induction chemotherapy, consolidation chemotherapy, neoadjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 20 Oct 2019 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the addition of 2 cycles of induction CapOx chemotherapy and 2 cycles of consolidation CapOx chemotherapy to standard chemoradiation improves 3-year disease-free survival in patients with locally advanced CRM"+" mid and low rectal cancer.
Detailed description
This trial aims to investigate the efficacy of adding neoadjuvant induction and consolidation chemotherapy compared to standard chemoradiotherapy in locally advanced rectal cancer patients with circumferential resection margin involvement. This is a prospective multicenter open-label randomized phase III clinical trial. Patients will be randomized using an online randomization system to receive either 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy OR chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), surgery (10-12 weeks following chemoradiotherapy) and 6 cycles of adjuvant CapOx chemotherapy. A stratification will be performed based on N stage, tumor location in the middle or low rectum and clinical center. Patients with middle or low rectal cancer without distant metastases, with involved circumferential resection margin (based on pretreatment MRI) will be included.
The target accrual is 270 patients in each treatment arm (including 10% potential data loss) based on potential benefit of 12% 3-yr disease-free survival (60% vs 72%), 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 is subject to central review. Conduction of this study and data collection are controlled by a local institutional board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant chemotherapy | Experimental | Drug: Capecitabine, Drug: Oxaliplatin, Radiation: Radiotherapy, Procedure: Rectal cancer surgeryPatients receive 2 cycles of induction CapOx (oxaliplatin 130 mg/m2 iv day 1, capecitabine 2000 mg/m2 per os bid days 1-14) chemotherapy, followed by chemoradiotherapy (54 Gy in 2 Gy fractions with concomitant capecitabine 825 mg/m2 per os bid on radiation days), then 2 cycles of consolidation CapOx chemotherapy, surgery (10-12 weeks following chemoradiotherapy) and 2 cycles of adjuvant CapOx chemotherapy |
| Chemoradiotherpy | Active comparator | Drug: Capecitabine, Drug: Oxaliplatin, Radiation: Radiotherapy, Procedure: Rectal cancer surgeryPatients receive 54 Gy pelvic chemoradiotherapy in 2 Gy fractions with capecitabine 825 mg/m2 bid per os on radiation days and then surgery following 10-12 weeks. After surgery patients receive 6 cycles of adjuvant CapOx chemotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent
- Histologically verified colon rectal adenocarcinoma 0-10 cm above the anal verge
- No distant metastases
- Circumferential resection margin (CRM) involvement (based on pelvic MRI)
- Eastern Cooperative Oncology Group (ECOG) status 0-2
Key exclusion criteria (18 listed)
- inability to obtain informed consent
- distant metastases
- cT2N0M0 rectal cancer
- synchronous or metachronous tumors
- previous chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineAlso: Xeloda2000 mg/m2, bid, per os, days 1-14 | Drug | Chemoradiotherpy, Neoadjuvant chemotherapy |
| Oxaliplatin130 mg/m2 iv day 1 | Drug | Chemoradiotherpy, Neoadjuvant chemotherapy |
| CapecitabineAlso: Xeloda825 mg/m2, bid, per os, only on days of radiation (Monday through Friday) | Drug | Chemoradiotherpy, Neoadjuvant chemotherapy |
| RadiotherapyPelvic radiotherapy dose: 44 Gy on regional nodes, 54 Gy on primary tumor in 2 Gy fractions | Radiation | Chemoradiotherpy, Neoadjuvant chemotherapy |
| Rectal cancer surgeryLaparoscopic or open total mesorectal excision or extralevator abdominoperineal resection | Procedure or surgery | Chemoradiotherpy, Neoadjuvant chemotherapy |
Primary outcome
3-year disease-free survival
Time frame: 3 years
8 secondary outcomes
Adjuvant chemotherapy compliance
Time frame: 6 months
Acute chemotherapy toxicity
Time frame: 6 months
pathologic complete response rate (pCR)
Time frame: 1 month
local recurrence rate
Time frame: 3 years
3-year overall survival
Time frame: 3 years
Operative morbidity
Time frame: 30 days
Preoperative tumor-associated complications rate
Time frame: 6 months
Sphincter preservation rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaman Z Mamedli, PhD principal investigator
N.N.Blokhin Russian Cancer Research Center
1 site in 1 country: see every site and its status.
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 18 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?
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.