Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Chinese PLA General Hospital | OTHER |
| Peking University Third Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental | Intervention:Anti-radiation spray (liquid dressing) |
|
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KANG FU PEN | Drug | FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree 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. | Within 1 week after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 to 24 months after radiotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuquan Zhang, MD | Contact | +86 010 6915 5485 | zhangfuquan3@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38705489 | Derived | Zhu J, Li X, Huang M, Zhu H, Tan Y, He X, Sun Z, Cheng H, Li F, Jiang P, Lou H, Ke G, Cao X, Zhu L, Xie P, Yan J, Zhang F. Application of Recombinant Human Superoxide Dismutase in Radical Concurrent Chemoradiotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Acute Rectal Injury: A Multicenter, Randomized, Open-label, Prospective Trial. Int J Radiat Oncol Biol Phys. 2024 Nov 1;120(3):720-729. doi: 10.1016/j.ijrobp.2024.04.070. Epub 2024 May 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Affiliated Cancer Hospital of Guizhou Medical University | OTHER |
| Zhejiang Cancer Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Henan Cancer Hospital | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
| Quality of life score |
EORTC QLQ-C30 (V3.0) was used to score quality of life before, during, and after radiotherapy. |
| 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. | 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. | 3 years after radiotherapy |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided