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

Launched by KAREN-LISE GARM SPINDLER · Nov 19, 2018

Keywords

ClinConnect Summary

The IMPROVE Intervention Trial is a study that aims to improve treatment for patients with colorectal cancer by analyzing a specific type of genetic material called circulating tumor DNA (ctDNA) after surgery. This trial is looking at how this analysis can help decide the best follow-up treatment for patients who have had their cancer surgically removed but still have detectable ctDNA in their blood. The hope is that this will lead to better outcomes for patients, such as longer periods without the cancer returning.

To join the trial, participants need to be adults aged 18 or older who have undergone surgery to remove colorectal cancer (specifically adenocarcinoma) that is at stage I or II. They must have detectable ctDNA in their blood two weeks after surgery and be deemed healthy enough for chemotherapy by the study doctors. Participants will receive close monitoring and potentially new treatment options based on their ctDNA results. It’s important to know that this trial is currently recruiting, and interested individuals should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

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