Health Trials

Contact Radiotherapy for Rectal Cancer

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexander Valdman

About this trial

The aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

cT1-cT3ab, < 5 cm largest diameter and < ½ circumference (MRI staging), N0-N1 (<= 3 nodes < 8mm diameter), M0

Performance status (ECOG) 0-1

Operable patient

Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm

Disqualifiers

Inoperable patient

T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference

Distance from the lower tumor border to the anal verge >10 cm

N2-status at diagnosis or N1 with any node>= 8 mm diameter

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy

    Radiation

    45/50 Gy (1.8/2 Gy/fraction/5 weeks)

  • Short-course radiotherapy

    Radiation

    25 Gy in 5 daily fractions over a total time of 1 week, treating 5 days per week, 1 fraction per day, using 5 Gy per fraction, over the maximum treatment period of eight calendar days

  • Contact x-ray brachytherapy

    Radiation

    90Gy/3 fractions/4 weeks

  • Chemotherapy

    Drug

    Capecitabine (900 mg/m2 bid, on radiation days)

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: CXB + CRTActive comparator 3 interventions
Group B: CXB + SCRTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Rectum preservation

Proportion of patients with successful rectum preservation after standard vs experimental treatment. Organ preservation is considered to have failed if the rectum is removed OR if the patient develops non-salvageable locoregional failure

Time frame
At 24 months after start of treatment

Secondary outcomes

1

Acute treatment-related toxicity

Incidence of grade 3-5 toxicity as assessed by CTCAE v5.0

Time frame
From start of treatment until 90 days after ending treatment
2

Late treatment related toxicity

Incidence of grade 3-5 toxicity as assessed by CTCAE v5.0

Time frame
From 90 days after ending treatment until end of study
3

Clinical complete response (cCR)

Proportion of patients with cCR as assessed by DRE, endoscopy, MRI-T2W, and MRI-DWI

Time frame
At 14-16 and 24-26 weeks after start of treatment
4

Postoperative complications

Difference in postoperative complications (graded according to Clavien-Dindo) after standard vs experimental treatment

Time frame
Within the first 30 days after Total Mesorectal Excision (TME) surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexander Valdman

Lead sponsor

Karolinska University Hospital

Sponsor institution

Uppsala University Hospital

Collaborator

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov
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