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

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ClinicalTrials.gov Identifier: NCT03748680
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Karen-Lise Garm Spindler, Aarhus University Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Circulating Tumor DNA Adjuvant Chemotherapy Progression Free Survival Drug: Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy Other: Intensified Follow-up Schedule Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A open label 1:1 randomized phase II exploratory study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implementing Non-invasive Circulating Tumor DNA Analysis to Optimize the Operative and Postoperative Treatment for Patients With Colorectal Cancer
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Active Comparator: A
Intensified follow-up schedule
Other: Intensified Follow-up Schedule
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.

Experimental: B
Adjuvant chemotherapy + intensified follow-up schedule
Drug: Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy

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)





Primary Outcome Measures :
  1. DFS [ Time Frame: 3 years ]
    Disease free survival


Secondary Outcome Measures :
  1. Molecular biological response [ Time Frame: 6 months ]
    Molecular biological response at 6 months

  2. MB-DFS [ Time Frame: 1 year ]
    Molecular biological disease free survival at 1 year

  3. TT-MBR [ Time Frame: 3 years ]
    Time to molecular biological recurrence

  4. TTR [ Time Frame: 3 years ]
    Time to radiological recurrence

  5. LRR [ Time Frame: 3 years ]
    Local recurrence rate

  6. DRR [ Time Frame: 3 years ]
    Distant recurrence rate

  7. OS [ Time Frame: 5 years ]
    Overall survival

  8. TR [ Time Frame: 3 years ]
    Translational research exploratory



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748680


Contacts
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Contact: Karen-Lise G Spindler, Professor 0045 7846 2535 ext +4578462535 k.g.spindler@rm.dk
Contact: Karen-Lise G Spindler, Professor +4578462535 ext +4578462535 k.g.spindler@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Karen-Lise G Spindler, Prof.    +457846 2535    k.g.spindler@rm.dk   
Contact: Line M Sparvath, CRN    457846 2610    linspa@rm.dk   
Sub-Investigator: Søren Lauerberg, Prof.         
Sub-Investigator: Claus L Andersen, Prof.         
Sponsors and Collaborators
Karen-Lise Garm Spindler

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Responsible Party: Karen-Lise Garm Spindler, Professor, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03748680     History of Changes
Other Study ID Numbers: KFE-1803
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents