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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
254
5 x 5 Gy external radiation therapy
Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
Stockholm, Solna, Sweden
RECRUITINGGävle Hospital
Gävle, Sweden
RECRUITINGSahlgrenska University Hospital
Gothenburg, Sweden
Incidence of acute grade 2-5 gastrointestinal toxicity
The incidence of acute preoperative grade 2-5 gastrointestinal toxicity according to CTCAE v5.0 associated with proton vs. photon radiotherapy
Time frame: From start of radiotherapy to planned start of the third (3) CAPOX cycle (week 9-10 of the trial)
Incidence of grade >2 hematologic and non-hematologic toxicity
The incidence of grade \>2 hematologic (blood count, febrile neutropenia) and non-hematologic toxicity (general, genitourinary, gastrointestinal, skin) associated with protocol treatment, assessed by CTCAE v5.0 in the preoperative period, the postoperative period, and overall. Patient reported side-effects will be assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire, the QLQ-C30, version 3. The QLQ-C30 will be supplemented with the disease specific module (rectal-cancer) QLQ-CR29. During radiotherapy, daily reported symptoms will be investigated by a newly developed symptom scale, Radiotherapy related symptom assessment scale (RSAS). The questionnaire includes 13 items specific for current diagnose. The RSAS is a validated instrument for assessing symptom intensity and distress in patients with different cancer disease undergoing radiotherapy, with psychometric properties within the expected range.
Time frame: Baseline up to five years after treatment
Differences in patient reported outcomes (PRO)
Differences in patient reported outcomes (PRO) between treatment arms in the preoperative period, the postoperative period, and overall
Time frame: Baseline, Day 1-5, 2 and 3 weeks, 3, 6, 9, 12, 24, 36 and 60 months
Proportion of patients being able to undergo full dose neoadjuvant chemotherapy
Differences between treatment arms in proportion of patients being able to undergo full dose neoadjuvant chemotherapy i.e. at least 4 cycles of CAPOX or 6 cycles of FOLFOX
Time frame: From week 3 until week 20 of the trial
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Linköping University Hospital
Linköping, Sweden
RECRUITINGSkåne University Hospital
Lund, Sweden
RECRUITINGStockholm South General Hospital
Stockholm, Sweden
RECRUITINGSundsvall Hospital
Sundsvall, Sweden
RECRUITINGUniversity Hospital of Umeå
Umeå, Sweden
RECRUITINGUppsala University Hospital
Uppsala, Sweden
RECRUITINGTumour regression grading (mrTRG)
Radiological assessment and comparison of tumour regression grading (mrTRG) between treatment arms
Time frame: Baseline to response evaluation week 16-17 of the trial
Cost effectiveness analysis measured by QALY
Health economic comparison between proton and photon treatment. Cost effectiveness analysis measured by QALY
Time frame: Time from randomization up to 5 years