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NEOadjuvant chemotherapy only compared with standard treatment for Locally Advanced Rectal cancer: a randomized phase II trial
EU CTIS ID: 2024-517748-76-00
What this study is testing
The aim of the present study is to compare long term and short term outcomes in rectal cancer patients undergoing standard treatment (radio-chemotherapy/surgery) or experimental neoadjuvant chemotherapy/surgery
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adenocarcinoma of the rectum with the lower boarder within 15 cm from the anal verge. Locally advanced tumor based on imaging (Tumors within 10 cm from the anal verge fulfilling the criteria for preoperative radio-chemotherapy according to DCCG guidelines, T3c or T4 tumors 10-15 cm from the anal verge). Deemed resectable at the multidisciplinary team (MDT) conference. ECOG performance status 0-2. Age at least 18 years. 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, 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 orally informed consent
You likely can't join if
- • Distant metastasis • Invasive ingrowth into other organs • Incapacity, frailty, disability and comorbidity to a degree that according to the investigator is not compatible with combination chemotherapy • Previous radiotherapy to the pelvis • Previous treatment with 5FU or oxaliplatin • Surgery within two weeks • 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.