Clinical trial · Interventional
Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Rectum | Malignant Rectal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 50.4 Gy to the tumor and elective volume | Radiation | — | UNRESOLVED |
| 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume | Radiation | — | UNRESOLVED |
| Capecitabine 825 mg/m2 twice daily on weekdays | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A: Standard chemoradiotherapy
- description
- 50.4 Gy to the tumor and elective volume. The dose is given in 28 fractions on weekdays concomitantly with capecitabine 825 mg/m2 twice daily on weekdays.
- interventionNames
- Radiation: 50.4 Gy to the tumor and elective volume
- Drug: Capecitabine 825 mg/m2 twice daily on weekdays
- type
- EXPERIMENTAL
- label
- B: High-dose radiotherapy
- description
- 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume. The dose is given in 28 fractions on weekdays concomitantly with capecitabine 825 mg/m2 twice daily on weekdays
- interventionNames
- Radiation: 62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume
- Drug: Capecitabine 825 mg/m2 twice daily on weekdays
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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