Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2033-12-31

Brief Summary

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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.

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Detailed Description

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The main curative treatment modality for rectal cancer is surgery, potentially combined with chemotherapy and radiotherapy to lower the risk of local recurrence. In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of patients may avoid surgery altogether if they can achieve a complete response to chemoradiotherapy. These studies have mainly focused on locally advanced tumors with a high risk of local recurrence. Smaller, less advanced tumors appear to respond better to chemoradiotherapy, but the optimal treatment for non-surgical management has not been established. 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. High-level evidence is currently absent for the question of radiotherapy dose, especially in early stage cancers.

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

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Cancer of Rectum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Enrollment will continue until 162 patients have reached the primary endpoint two years after start of treatment. During these two years the total number of patients will therefore expectedly increase to approximately 290. This will be the population for secondary analyses and long-term follow-up.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A: Standard chemoradiotherapy

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.

Group Type ACTIVE_COMPARATOR

50.4 Gy to the tumor and elective volume

Intervention Type RADIATION

Standard radiotherapy

Capecitabine 825 mg/m2 twice daily on weekdays

Intervention Type DRUG

Standard chemotherapy

B: High-dose radiotherapy

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

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

Experimental radiotherapy

Capecitabine 825 mg/m2 twice daily on weekdays

Intervention Type DRUG

Standard chemotherapy

Interventions

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50.4 Gy to the tumor and elective volume

Standard radiotherapy

Intervention Type RADIATION

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

Experimental radiotherapy

Intervention Type RADIATION

Capecitabine 825 mg/m2 twice daily on weekdays

Standard chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No