NCT04095299 Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
| NCT ID | NCT04095299 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Vejle Hospital |
| Condition | Cancer of Rectum |
| Study Type | INTERVENTIONAL |
| Enrollment | 162 participants |
| Start Date | 2020-01-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 162 participants in total. It began in 2020-01-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level. The aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.
Eligibility Criteria
Inclusion Criteria: * Histopathologically verified adenocarcinoma of the rectum * MDT conference finds patient a candidate for rectal resection * Clinical tumor category cT1-3 * MRI findings * Maximal cross-sectional size of 4.5 cm (axial plane relative to the rectum) * Lowest edge of tumor located at or below the peritoneal reflection on MRI * Performance status 0-2 * Age ≥ 18 years * Eligible for radiotherapy and capecitabine according to investigator, including * Adequate function of bone marrow (neutrophils ≥ 1.5 x 10\^9/l and thrombocytes ≥ 100 x 10\^9/l) * Adequate function of liver (ALAT \< 2.5 x upper limit of normal, bilirubin \< 2.5 x upper limit of normal) * Adequate kidney function (Serum creatinine \< 1.5 x upper limit of normal or measured GFR \> 30 ml/min) * Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment * Written and orally informed consent Exclusion Criteria: * Previous surgical treatment of the present cancer, including transanal excision of tumor * Other malignant disease within the past five years except non-melanoma skin cancer and premalignant lesions such as carcinoma in situ * Distant metastases verified by imaging or biopsy, i.e. cM1 * Previous radiation treatment of the pelvis * Pregnant or breastfeeding women. * Existing colostomy or ileostomy
Contact & Investigator
Lars H Jensen, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark
Frequently Asked Questions
Who can join the NCT04095299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer of Rectum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04095299 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 162 participants.
Is NCT04095299 currently recruiting?
Yes, NCT04095299 is actively recruiting participants. Contact the research team at lars.henrik.jensen@rsyd.dk for enrollment information.
Where is the NCT04095299 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Copenhagen, Denmark, Næstved, Denmark, Roskilde, Denmark and 1 additional location.
Who is sponsoring the NCT04095299 clinical trial?
NCT04095299 is sponsored by Vejle Hospital. The principal investigator is Lars H Jensen, MD, PhD at Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark. The trial plans to enroll 162 participants.
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