Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury
NCT ID: NCT04819685
Last Updated: 2021-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
520 participants
INTERVENTIONAL
2021-03-01
2025-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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test group
Intervention:Anti-radiation spray (liquid dressing)
KANG FU PEN
FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays
control group
No interventions assigned to this group
Interventions
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KANG FU PEN
FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
FEMALE
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Chinese PLA General Hospital
OTHER
Peking University Third Hospital
OTHER
Peking University Cancer Hospital & Institute
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Sun Yat-sen University
OTHER
Jilin Provincial Tumor Hospital
OTHER
Fudan University
OTHER
Shandong Cancer Hospital and Institute
OTHER
The First Affiliated Hospital of Air Force Medicial University
OTHER
Guizhou Cancer Hospital (The Affiliated Cancer Hospital of Guizhou Medical University)
UNKNOWN
Zhejiang Cancer Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
Henan Cancer Hospital
OTHER_GOV
Peking Union Medical College Hospital
OTHER
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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KFP for RTI rectal injury
Identifier Type: -
Identifier Source: org_study_id
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