Cervical Cancer, Radiotherapy; Complications, Radiotherapy Side Effect
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGKANG FU PEN
FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chinese PLA General Hospital
Peking University Third Hospital
Peking University Cancer Hospital & Institute
Jiangsu Cancer Institute & Hospital
Sichuan Cancer Hospital and Research Institute
Sun Yat-sen University
Jilin Provincial Tumor Hospital
Fudan University
Shandong Cancer Hospital and Institute
The First Affiliated Hospital of Air Force Medicial University
Guizhou Cancer Hospital (The Affiliated Cancer Hospital of Guizhou Medical University)
Zhejiang Cancer Hospital
Xiangya Hospital of Central South University
Henan Cancer Hospital
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. The patient is completely voluntary and has the ability to sign the research informed consent form within 30 days before enrollment; 2. Age ≥18 years old and ≤65 years old; 3. Pathologically confirmed cervical cancer; 4. Those with IB3, IIA2, IIB, IIIA, IIIB, and those with cervical tumor ≥ 4cm or involved parametrial in IIIC1 and IIIC2 (FIGO 2018 staging); 5. ECOG score 0-2 points; 6. The complete blood count and basal metabolic indexes in the 14 days before enrollment must meet the following requirements: NEUT≥1.5\*10\^9/L, HGB≥80g/L, PLT≥100\*10\^9/L, blood creatinine \< 1.5mg/dl (133umol/L), AST and ALT are within 2 times of the upper limit of normal; 7. Those who have had regular bowel movements and had a negative stool routine test + occult blood before enrollment.
Exclusion criteria
1. Those who have a history of allergy to superoxide dismutase use; 2. Patients with skin and mucous membrane infections, patients with obvious empyema or pelvic inflammatory disease; 3. Those who have had chronic colitis, ulcerative colitis, and non-specific proctitis in the past; 4. Those who have received cervical cancer surgery (including pelvic or retroperitoneal lymphadenectomy, excluding tumor biopsy), radiotherapy or chemotherapy; 5. Those who are expected to be unable to receive brachytherapy, or brachytherapy needs to use tumor elimination, uterine tube inserted alone in one fraction, or template plan; 6. Those who need to use fluorouracil or capecitabine or tigio in the concurrent chemotherapy regimen; 7. History of other malignant tumors; 8. Pregnant or lactating women; 9. Accompanied by active infection and fever; 10. Other serious diseases that may significantly affect the compliance of clinical trials, such as unstable heart disease, kidney disease, chronic hepatitis, poorly controlled diabetes, and mental illness that require treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of rectal mucosal injury caused by acute radiation | Within 1 week after radiotherapy | the incidence of Vienna rectoscopy score ≥2 within 1 week after radiotherapy. Vienna rectoscopy score was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of rectal injury caused by chronic radiation | 3 to 24 months after radiotherapy | 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. |
| Quality of life score | 3 to 24 months after radiotherapy | EORTC QLQ-C30 (V3.0) was used to score quality of life before, during, and after radiotherapy. |
| overall survival (OS) | 3 years after radiotherapy | 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. |
| disease-progression-free survival (PFS) | 3 years after radiotherapy | 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. |
Countries
China
Contacts
Primary ContactFuquan Zhang, MD
Outcome results
None listed