Clinical trial NCT04819685: Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury
Official title: Application of KANG FU PEN (Protective Irrigation Solution Against Rays) in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury：a Multicenter, Prospective, Randomized Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cervical Cancer
Radiotherapy Side Effect
Radiotherapy; Complications
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Chinese PLA General Hospital
name: Peking University Third Hospital
name: Peking University Cancer Hospital & Institute
name: Jiangsu Cancer Institute & Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Sun Yat-sen University
name: Jilin Provincial Tumor Hospital
name: Fudan University
name: Shandong Cancer Hospital and Institute
name: The First Affiliated Hospital of Air Force Medicial University
name: Guizhou Cancer Hospital (The Affiliated Cancer Hospital of Guizhou Medical University)
name: Zhejiang Cancer Hospital
name: Xiangya Hospital of Central South University
name: Henan Cancer Hospital
First posted: 2021-03-29
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Degree of rectal mucosal injury caused by acute radiation
timeFrame: Within 1 week after radiotherapy
Secondary outcomes:
measure: Degree of rectal injury caused by chronic radiation
timeFrame: 3 to 24 months after radiotherapy
measure: Quality of life score
timeFrame: 3 to 24 months after radiotherapy
measure: overall survival (OS)
timeFrame: 3 years after radiotherapy
measure: disease-progression-free survival (PFS)
timeFrame: 3 years after radiotherapy
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References: