RecruitingPhase 3NCT04095299

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)


Sponsor

Vejle Hospital

Enrollment

162 participants

Start Date

Jan 20, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a higher dose of radiation combined with chemotherapy can allow some rectal cancer patients to avoid surgery entirely — preserving the rectum. It compares a standard radiation dose to a higher dose, both given alongside chemotherapy (capecitabine). **You may be eligible if...** - You are 18 or older - You have rectal cancer (adenocarcinoma) confirmed by biopsy - The tumor is in the lower part of the rectum and measures no more than 4.5 cm across on MRI - Surgery has been recommended as a treatment option by a multidisciplinary team - Your blood counts, liver, and kidney function are adequate - You are not pregnant **You may NOT be eligible if...** - You have already had surgery or local treatment for this cancer - The cancer has spread to other parts of the body - You have had pelvic radiation before - You have had another cancer in the past 5 years (except non-melanoma skin cancer) - You are pregnant or breastfeeding - You already have a colostomy or ileostomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATION50.4 Gy to the tumor and elective volume

Standard radiotherapy

RADIATION62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume

Experimental radiotherapy

DRUGCapecitabine 825 mg/m2 twice daily on weekdays

Standard chemotherapy


Locations(5)

Aalborg University Hospital

Aalborg, Denmark

Copenhagen University Hospital, Righshospitalet and Bispebjerg Hospital

Copenhagen, Denmark

Zealand University Hospital, Næstved

Næstved, Denmark

Zealand University Hospital, Roskilde

Roskilde, Denmark

Department of Oncology, Vejle Hospital

Vejle, Denmark

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NCT04095299


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