Comparing standard and high doses of radiotherapy for rectal cancer treatment
Randomized Trial of Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy to Patients With Early Low and Mid Rectal Cancer: The Watchful Waiting 3 Trial (WW3)
This study is testing if a higher dose of radiotherapy works better than a standard dose for people with early rectal cancer who are also getting chemotherapy, to see if they can avoid surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vejle Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 5 sites (Aalborg and 4 other locations) |
| Trial ID | NCT04095299 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a higher dose of radiotherapy is more effective than a standard dose in patients with early rectal cancer who are receiving chemoradiotherapy. The research aims to determine if patients can avoid surgery by achieving a complete response to treatment. It focuses on patients with histopathologically verified adenocarcinoma of the rectum and evaluates their response to different radiation doses combined with chemotherapy. The study is designed to provide high-level evidence regarding the optimal radiotherapy dose for non-surgical management of early-stage rectal cancer.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with early-stage rectal cancer who are eligible for radiotherapy and chemotherapy.
Not a fit: Patients with advanced rectal cancer or those who have previously undergone surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could allow some rectal cancer patients to avoid surgery while still achieving effective treatment.
How similar studies have performed: Previous trials have shown promising results in organ preservation for early rectal cancer, but this specific approach to dose comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 4 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
- Zealand University Hospital, Næstved — Næstved, Denmark (Recruiting)
- Zealand University Hospital, Roskilde — Roskilde, Denmark (Recruiting)
- Department of Oncology, Vejle Hospital — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Lars H Jensen, MD, PhD — Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark
- Study coordinator: Lars H Jensen, MD, PhD
- Email: lars.henrik.jensen@rsyd.dk
- Phone: +45 7940 6802
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.