Rectal CancerPhase 4NCT04747951
Total Neoadjuvant Therapy in Rectal Cancer Treatment
A Phase 4 study testing Concurrent Chemoradiotherapy, TME and consolidation chemotherapy in people with Rectal Cancer, run by State Scientific Centre of Coloproctology, Russian Federation at 1 site in Russia.
Trial summary
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment. 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?
- Concurrent Chemoradiotherapy, TME and consolidation chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteRussia
- Study dates
- 30 Oct 2020to 1 Nov 2023
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed an approved informed consent form for the stud;
- Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);
Who cannot join
- rectal cancer recurrence;
- Primary-multiple tumours of other localizations;
- pelvis radiotherapy in anamnesis;
- pregnancy, breastfeeding;
- distant metastasis;
- ECOG score 3-4
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
State Scientific Centre of Coloproctology
Moscow, 123453
Sergey Sychev, +79097845436 ext. +79097845436, dr.sychev.si@gmail.com
About this study
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
Read the detailed description
In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.
- Conditions
- Rectal Cancer
- Being tested
- Concurrent Chemoradiotherapy, TME, consolidation chemotherapy, adjuvant chemotherapy
- Keywords
- rectal cancer, total neoadjuvant therapy, colorectal disease
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent ChemoradiotherapyCombination product
Also called Radiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Concurrent chemotherapy:
Capecitabine 1650 mg/m2/d
TMEProcedure or surgery
Total mesorectal excision
consolidation chemotherapyDrug
Also called XELOX, CAPOX
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course
adjuvant chemotherapyDrug
Also called mFOLFOX
Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles
| Study group | Role | What they receive |
|---|---|---|
| total neoadjuvant therapy | Experimental | Total neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary. Receives: Combination Product: Concurrent Chemoradiotherapy; Procedure: TME; Drug: consolidation chemotherapy; Drug: adjuvant chemotherapy |
| standard therapy | Active comparator | Standard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy) Receives: Combination Product: Concurrent Chemoradiotherapy; Procedure: TME; Drug: adjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of complete responses
The rate of pathological or clinical complete responses
Measured: 3-6 months
Secondary outcomes (3)
Rate of R0-resections
Rate of R0-resections
Measured: immediately after surgery
Rate of compliance with radiotherapy and chemotherapy
Rate of complications III-VI grade of radiotherapy (RTOG) and chemotherapy (NCI-CTC)
Measured: 6-8 months
rate of intraoperative and postoperative complications
Frequency and structure of intraoperative and postoperative complications according to the Clavien-Dindo classification
Measured: 0-30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start30 Oct 2020
- Primary completion30 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian Federation
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rybakov Evgeny, MD, State Scientific Centre of Coloproctology, Russian Federation
- Investigators
- Evgeny Rybakov, Dr.Med.Sc, Principal investigator, Head of Surgical department of oncoproctology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747951
- Sponsor's protocol ID
- 127872
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23.
PubMed 22362002Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21.
PubMed 22434243Rodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24.
PubMed 16246976
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Neoadjuvant Therapy in Rectal Cancer Treatment
- ClinicalTrials.gov ID
- NCT04747951
- Acronym / sponsor ID
- 127872
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer, total neoadjuvant therapy, colorectal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- State Scientific Centre of Coloproctology, Russian FederationOther government
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 10 Feb 2021 (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.
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
Detailed description
In this randomized, controlled, parallel study we will comparison total neoadjuvant therapy with standard neoadjuvant therapy in rectal cancer treatment. Complete pathological response rate will be the primary endpoint in patients, who will undergoing surgery. In cases of complete clinical response we will provide "watch and wait" approach. Compliance of treatment and oncologic results will be the second endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| total neoadjuvant therapy | Experimental | Combination Product: Concurrent Chemoradiotherapy, Procedure: TME, Drug: consolidation chemotherapy, Drug: adjuvant chemotherapyTotal neoadjuvant therapy consisted chemoradiotherapy with capecitabine and nine weeks of consolidation chemotherapy with XELOX prior to surgery and adjuvant therapy if necessary. |
| standard therapy | Active comparator | Combination Product: Concurrent Chemoradiotherapy, Procedure: TME, Drug: adjuvant chemotherapyStandard therapy (neoadjuvant chemoradiotherapy, surgery, adjuvant chemotherapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have signed an approved informed consent form for the stud;
- Histologically confirmed rectal adenocarcinoma low (cT2-4N0-2M0) or mid rectum (сТ2-T4N1-2M0);
Key exclusion criteria (6 listed)
- rectal cancer recurrence;
- Primary-multiple tumours of other localizations;
- pelvis radiotherapy in anamnesis;
- pregnancy, breastfeeding;
- distant metastasis;
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 |
|---|---|---|
| Concurrent ChemoradiotherapyAlso: Radiotherapy50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d | Combination product | standard therapy, total neoadjuvant therapy |
| TMETotal mesorectal excision | Procedure or surgery | standard therapy, total neoadjuvant therapy |
| consolidation chemotherapyAlso: XELOX, CAPOXIntravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course | Drug | total neoadjuvant therapy |
| adjuvant chemotherapyAlso: mFOLFOXAdministration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles | Drug | standard therapy, total neoadjuvant therapy |
Primary outcome
The rate of complete responses
Time frame: 3-6 months
The rate of pathological or clinical complete responses
3 secondary outcomes
Rate of R0-resections
Time frame: immediately after surgery
Rate of compliance with radiotherapy and chemotherapy
Time frame: 6-8 months
rate of intraoperative and postoperative complications
Time frame: 0-30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Background: PubMed 22362002Martin ST, Heneghan HM, Winter DC. Systematic review and meta-analysis of outcomes following pathological complete response to neoadjuvant chemoradiotherapy for rectal cancer. Br J Surg. 2012 Jul;99(7):918-28. doi: 10.1002/bjs.8702. Epub 2012 Feb 23.
- Background: PubMed 22434243Zorcolo L, Rosman AS, Restivo A, Pisano M, Nigri GR, Fancellu A, Melis M. Complete pathologic response after combined modality treatment for rectal cancer and long-term survival: a meta-analysis. Ann Surg Oncol. 2012 Sep;19(9):2822-32. doi: 10.1245/s10434-011-2209-y. Epub 2012 Mar 21.
- Background: PubMed 16246976Rodel C, Martus P, Papadoupolos T, Fuzesi L, Klimpfinger M, Fietkau R, Liersch T, Hohenberger W, Raab R, Sauer R, Wittekind C. Prognostic significance of tumor regression after preoperative chemoradiotherapy for rectal cancer. J Clin Oncol. 2005 Dec 1;23(34):8688-96. doi: 10.1200/JCO.2005.02.1329. Epub 2005 Oct 24.
- 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.
Evgeny Rybakov, Dr.Med.Sc principal investigator
Head of Surgical department of oncoproctology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Concurrent Chemoradiotherapy, TME and consolidation chemotherapy in people with Rectal Cancer, run by State Scientific Centre of Coloproctology, Russian Federation 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 2 inclusion and 6 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 15 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Sergey Sychev, Dr.Med.Sc (+7 9097845436, dr.sychev.si@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of complete responses (time frame: 3-6 months). 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 NCT04747951, which also lists 3 linked publications.
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 15 Feb 2021.