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

NCT03748680 | Unknown Phase 2 DMC

• 1 other identifier: KFE-1803
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

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.

Conditions

Colorectal Cancer; Circulating Tumor DNA; Adjuvant Chemotherapy; Progression Free Survival

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease free survival

  3 years

Secondary Outcomes (8)

• Molecular biological response

  6 months

• MB-DFS

  1 year

• TT-MBR

  3 years

• TTR

  3 years

• LRR

  3 years

Study Arms (2)

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

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)

B

Intensified Follow-up Schedule OTHER

Close monitoring with Imaging during follow-up Patients included in this trial will undergo intensified follow-up with CT-chest and abdomen every four months after surgery for the first 2 years, then every 6 months for 1 years and finally once yearly for the last 2 years up to 5 years follow-up is completed.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karen-Lise Garm Spindler: lead

Study Sites (4)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8000, Denmark

RECRUITING

Herlev Hospital

Herlev, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Karen-Lise G Spindler, Professor

CONTACT

0045 7846 2535; k.g.spindler@rm.dk

Karen-Lise G Spindler, Professor

CONTACT

+4578462535; k.g.spindler@rm.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A open label 1:1 randomized phase II exploratory study

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2025
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)