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Compares treatment options for Cancer of Rectum
Official title Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
ClinicalTrials.gov ID: NCT04095299
What this study is testing
What is Capecitabine 825 mg/m2 twice daily on weekdays?
Capecitabine 825 mg/m2 twice daily on weekdays is an investigational medicine, being studied as a potential treatment for cancer of rectum.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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 \ 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Copenhagen, Denmark
- Næstved, Denmark
- Roskilde, Denmark
- Vejle, Denmark
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Copenhagen, Denmark; Næstved, Denmark; Roskilde, Denmark; Vejle, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.