Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)

  • STATUS
    Recruiting
  • End date
    Mar 14, 2028
  • participants needed
    254
  • sponsor
    Alexander Valdman
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Updated on 4 October 2022
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Summary

To investigate a potential toxicity benefit of preoperative radiation therapy with protons compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer.

Description

The aim of this study is to investigate whether proton beam radiotherapy in locally advanced rectal cancer can offer meaningful reductions in acute gastrointestinal toxicity compared to standard treatment with photons which may improve patient's tolerability of neoadjuvant chemotherapy.

There are currently no published clinical reports evaluating the use of proton therapy in the upfront treatment of locally advanced rectal cancer. There are further no published randomized trials comparing radiotherapy with photon vs proton in locally advanced rectal cancer.

This is a prospective randomized trial, initially run at the limited number of centres but later expanded to other centres participating in the Skandion network. Patients will be treated with short course 5 x 5 Gy radiation scheme with either photons (standard arm) or protons (Skandion clinic) followed by four to six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery. The rectal tumour will be removed by TME/PME surgery or more extensive surgery if required because of tumour extent.

All patients will receive at least 4 courses of CAPOX (Capecitabine b.i.d.1000 mg/m2 day 1-14 every 3 weeks, Oxaliplatin 130 mg/m2 day 1 every 3 weeks) week 3-14, followed by surgery at week 17-20.

Details
Condition Colorectal Cancer, Colorectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, Rectal Cancer, Rectal Cancer, Colon Cancer Screening, Colon cancer; rectal cancer, rectal carcinoma
Treatment radiation therapy
Clinical Study IdentifierNCT04525989
SponsorAlexander Valdman
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Inclusion Criteria - Primary tumour characteristics
Biopsy-proven, newly diagnosed primary rectal adenocarcinoma, i.e. with the lowest part of the tumour less than 16 cm from the anal verge detected using a rigid rectoscope
Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically
Clinical stage (c) T4b, i.e. infiltration of an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side-wall (according to TNM version 8)
cT4a, i.e. peritoneal involvement
Extramural vascular invasion (EMVI+)
N2-status regarded as metastatic according to ESGAR consensus criteria
Positive MRF, i.e. tumor or lymph node one mm or less from the mesorectal fascia
Metastatic lateral nodes (lat LN+) according to ESGAR consensus criteria
Inclusion Criteria - General
Staging done within 6 weeks before start of radiotherapy. No contraindications to chemotherapy with CAPOX including adequate blood counts, (within 5 weeks prior to randomisation)
white blood count 4.0 x 109/L
platelet count 100 x 109/L
clinically acceptable haemoglobin levels
creatinine levels indicating renal clearance of 50 ml/min
bilirubin 35 mol/l
ECOG performance score 1
Patient is considered to be mentally and physically fit for chemotherapy with CAPOX as judged by the oncologist
Age 18 years
Written informed consent
Adequate potential for follow-up

Exclusion Criteria

Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen
Presence of metastatic disease or recurrent rectal tumour. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis
Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years
Known DPD deficiency
Any contraindications to MRI (e.g. patients with pacemakers)
Medical or psychiatric conditions that compromise the patient's ability to give informed consent
Concurrent uncontrolled medical conditions
Any investigational treatment for rectal cancer within the past month
Pregnancy or breast feeding
Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months
Patients with symptoms of peripheral neuropathy
Patients with pacemaker or ICD
Patients with bilateral hip protheses
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