A total of 520 cases will be randomly divided into Kang Fu Pen (liquid dressing) enema intervention group (experimental group) and non-enema intervention group (control group), according to the ratio of 1:1.
All patients are planned to receive radical concurrent chemoradiotherapy. Intensity modulated radiotherapy (IMRT) will be used for external irradiation, with a dose of 45-50.4Gy /25-28 fractions. Combined three-dimensional intracavitary/interstitial (IC/IS) brachytherapy was applied. The preferred dose fraction plan is 6Gy\*5 fractions, or 7Gy\*4 fractions. Whether to adopt supplement radiotherapy can be decided by the tumor regression. Cisplatin 40 mg/m2 is recommended as the first choice for concurrent chemotherapy, and TP or TC can also be considered. Single-drug weekly therapy should be completed for at least 3 cycles, and combined 3-week regimen should be completed for at least 1 cycle. Experimental group: from three days before radiotherapy to one week after radiotherapy, Kang Fu Pen (recombinant human superoxide dismutase) retention enema, 50ml/ time, once every other day. When rectal mucosa II degree reactions (NCI-CTCAE 5.0) occur, it is changed to 1 day/time until 1 week after mucosal remission. Control group: 3 days before radiotherapy to the end of radiotherapy, no drug retention enema was used.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
520
FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays
Peking Union Medical College Hospital
Beijing, China
RECRUITINGDegree of rectal mucosal injury caused by acute radiation
the incidence of Vienna rectoscopy score ≥2 within 1 week after radiotherapy. Vienna rectoscopy score was used.
Time frame: Within 1 week after radiotherapy
Degree of rectal injury caused by chronic radiation
incidence of RTOG score ≥2 at 3 to 24 months after radiotherapy. If the RTOG score ≥2 at 3 to 24 months after radiotherapy, rectoscopy will be used to evaluate the degree. If the RTOG score is 0 or 1, clinical classification is enough.
Time frame: 3 to 24 months after radiotherapy
Quality of life score
EORTC QLQ-C30 (V3.0) was used to score quality of life before, during, and after radiotherapy.
Time frame: 3 to 24 months after radiotherapy
overall survival (OS)
Overall survival (OS) is defined as the time interval from randomization to death from any cause or, if no death, to the last follow-up.
Time frame: 3 years after radiotherapy
disease-progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time between randomization and the occurrence of local or regional recurrence, or distant metastasis, or death from any cause, based on the time of the first event and, if none of these events occurred, to the last follow-up.
Time frame: 3 years after radiotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.