IMPROVE Intervention Trial Implementing Non-invasive Circ... | NCT03748680

Studies
IMPROVE Intervention Trial Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer

NCT03748680

Sponsor

Karen-Lise Garm Spindler

Status

Unknown status

Last Update Posted

Feb 25, 2022Actual

Enrollment

64Estimated

Phase

Phase 2

Conditions

Colorectal Cancer
Circulating Tumor DNA
Adjuvant Chemotherapy
Progression Free Survival

Interventions

Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy
Intensified Follow-up Schedule

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2018Actual

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Nov 19, 2018

First Submission Date that Met QC Criteria

Nov 19, 2018

First Posted Date

Nov 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2022

Last Update Posted Date

Feb 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A open label 1:1 randomized phase II exploratory study investigating adjuvant therapy in patients with molecular biologically detectable residual disease after primary resection for localized colorectal tumors.

Detailed Description

The main clinical hypothesis is that patients having undergone radical resection from CRC do not present with detectable tumor DNA in the plasma, whereas patients with detectable tumor DNA two weeks' post surgery have residual microscopic disease, and consequently a high risk of diseases recurrence which can be prevented with adjuvant chemotherapy.

The primary aim of the present study is to investigate - in a randomized trial - if use of standard adjuvant chemotherapy therapy improves the disease free survival in patients with molecular biological residual disease where adjuvant chemotherapy is not standard treatment .

Secondary aims include investigating molecular biological response to adjuvant chemotherapy in patients with post-operative ctDNA.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator	Intensified follow-up schedule	Other: Intensified Follow-up Schedule
B	Experimental	Adjuvant chemotherapy + intensified follow-up schedule	Drug: Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy	Drug	Six months of adjuvant combination chemotherapy with Capox (or FOLFOX) Patients will receive adjuvant chemotherapy with eight cycles of CAPOX (oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks. (Patients with an ileostomy are only eligible for FOLFOX and will be treated with 12 cycles of FOLFOX (oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every second weeks)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DFS	Disease free survival	3 years

Secondary Outcomes

Measure	Description	Time Frame
Molecular biological response	Molecular biological response at 6 months	6 months
MB-DFS	Molecular biological disease free survival at 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgically removed Adenocarcinoma of the colon or rectum
Pathologically stage I or II disease, and radical resection
Detectable ctDNA in two weeks postoperative plasma sample
No indication for adjuvant chemotherapy according to DCCG guidelines (website)
Age at least 18 years
ECOG performance status 0-2
Clinically eligible for adjuvant chemotherapy at investigators decision.
Adequate bone marrow, liver and renal function allowing systemic chemotherapy (Absolute neutrophil count ≥1.5x109/l and thrombocytes ≥ 100x109/l. Bilirubin ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value, and Calculated or measured renal glomerular filtration rate at least 30 mL/min)
Anticonception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable •
Written and verbally informed consent

Exclusion Criteria:

Radiological evidence of distant metastasis, by CT- chest and abdomen
Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy
Previous treatment with 5FU or oxaliplatin
Neuropathy NCI grade > 1
Other malignant tumor within 5 years except non-melanoma skin cancer or carcinoma in situ cervicis uteri
Pregnant (positive pregnancy test) or breast feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karen-Lise G Spindler, Professor	Contact	0045 7846 2535	+4578462535	k.g.spindler@rm.dk
Karen-Lise G Spindler, Professor	Contact	+4578462535	+4578462535	k.g.spindler@rm.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg University Hospital	Recruiting	Aalborg			Denmark
Aarhus University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases