Overview
Sponsor-declared trial summary
Rectal cancer
Applying a systemic control with precision approach over the course of the rectal cancer therapy is logistically feasible Applying a systemic control and precision approach as a treatment strategy, recurrence-free survival of rectal cancer patients is improved
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-09-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517149-15-00
- EudraCT number
- 2020-003697-52
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Applying a systemic control with precision approach over the course of the rectal cancer therapy is logistically feasible
Applying a systemic control and precision approach as a treatment strategy, recurrence-free survival of rectal cancer patients is improved
Conditions and MedDRA coding
Rectal cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) rectal adenocarcinoma, 2) WHO performance status 0-1, assessed by the MDT to be able to undergo CAPOX (capecitabine and oxaliplatin) treatment, 3) mrEMVI+ and 4) assessed by the MDT to require either RT or CRT by the current standards. In general, indications for clinical rectal carcinoma MDT to recommend RT or CRT are: T3-4 tumor at mid- or low rectum location, involvement of lymph nodes, threatened operative margin or mrEMVI
Exclusion criteria 1
- 1.) deficient MMR status, non-DPYD genotype 2) a contraindication to capecitabine, oxaliplatin or RT, 3) failing in blood tests that describe the adequate circulatory 4) liver and kidney function for chemotherapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Recurrence-free survival at 3 (and 5) years at intention-to-treat analysis
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Capecitabine Orion 150 mg kalvopäällysteiset tabletit
PRD1625260 · Product
- Active substance
- Capecitabine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2000 mg/m2 milligram(s)/square meter
- Max total dose
- 56000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC06 — CAPECITABINE
- Marketing authorisation
- 31391
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin Accord 5 mg/ml, infuusiokonsentraatti, liuosta varten.
PRD1785481 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 85 mg/m2 milligram(s)/sq. meter
- Max total dose
- 340 mg/m2 milligram(s)/square meter
- Max treatment duration
- 10 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- 26943
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Haartmaninkatu 4
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Toni Seppälä
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Toni Seppälä
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 100 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Syncope_protocol_FINAL | 3 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Suostumus tutkimukseen | 1 |
| Subject information and informed consent form (for publication) | Tiedote tutkittavalle SYNCOPE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Capecitabine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Oxaliplatin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-11 | Finland | Acceptable 2024-09-24
|
2024-09-24 |