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This phase II clinical study plan to recruit 100 subjects, 1:1 divide them into experimental group and control group, and the cumulative D2cc dose for rectum during brachytherapy will be recorded and compared.
This phase II prospective, multicenter, randomized, parallel-controlled, superiority clinical study will select more than three hospitals with national clinical trial institution qualifications as clinical trial centers, plan to recruit 100 subjects, 50 in experimental group and 50 in control. The patients in expermental group will receive brachytherapy after the hydrogel injection while patients in control group will receive brachytherapy without hydrogel. The aim of the study was to evaluate whether the use of ReSpace⢠hydrogel results in a reduction of radiation exposure to the anterior rectum, and to assess its safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSpace⢠& gauze packing | Experimental | All of the subjects will undergo palcement of ReSpace⢠hydrogel together with gauze packing in the vagina before brachytherapy |
|
| gauze packing | Active Comparator | All of the subjects will undergo palcement of gauze packing alone in the vagina before brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSpace⢠| Device | The experimental group subjects will be injected with ReSpace⢠hydrogel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative D2cc dose for rectum during brachytherapy | The mean of the cumulative rectum D2cc dose during brachytherapy will be calculated for subjects and be compared between the groups. | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy | The mean of the cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy will be calculated for subjects and be compared between the groups. | during procedure |
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Inclusion Criteria:
⢠Patients with pathologically confirmed cervical cancer who must be scheduled to undergo radical radiotherapy by means of intensity-modulated radiotherapy combined with 3D brachytherapy.
Exclusion Criteria:
ā¢Subjects who have received prior pelvic radiotherapy.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuquan Zhang, doctor | Contact | +86 13311360431 | zhangfuquan3@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22484226 | Background | de Freitas AC, Gurgel AP, Chagas BS, Coimbra EC, do Amaral CM. Susceptibility to cervical cancer: an overview. Gynecol Oncol. 2012 Aug;126(2):304-11. doi: 10.1016/j.ygyno.2012.03.047. Epub 2012 Apr 4. | |
| 30237814 | Background | Peach MS, Moore J, Giles W, Trainor J, Long T, Moon N, Hylton JE, Showalter TN, Libby B. Development and preclinical testing of a novel biodegradable hydrogel vaginal packing technology for gynecologic high-dose-rate brachytherapy. J Contemp Brachytherapy. 2018 Aug;10(4):306-314. doi: 10.5114/jcb.2018.77952. Epub 2018 Aug 31. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| gauze packing | Device | The subjects of both groups will be given gauze packing |
|
| The implantation success rate of hydrogel. |
A successful injection means the hydrogel is placed between the cervical and rectum |
| during procedure |
| The stability of ReSpace⢠Hydrogel | The maximum distance of cervical to rectum of different time during the procedure will be compared to assess the stability of hydrogel. | during procedure |
| QLQ-C30 | The EORTC QLQ-C30 questionaire will assessed among the subjects during the procedure, and comparioson will be made between the groups and inside the groups of different time. Scores range from 0 to 100, higher scores menas a better outcome. | during procedure |
| QLQ-CX24 | The EORTC QLQ-CX24 questionaire will assessed among the subjects during the procedure, and comparioson will be made between the groups and inside the groups of different time. Scores range from 0 to 100, higher scores menas a better outcome. | during procedure |
| Evaluation of device performance of hydrogel spacer | The ease of use of the test device will be evaluated by the investigator on the day of Operation. The evaluation items are as follows#
| during procedure |
| 31034570 | Background | Kashihara T, Murakami N, Tselis N, Kobayashi K, Tsuchida K, Shima S, Masui K, Yoshida K, Takahashi K, Inaba K, Umezawa R, Igaki H, Ito Y, Kato T, Uno T, Itami J. Hyaluronate gel injection for rectum dose reduction in gynecologic high-dose-rate brachytherapy: initial Japanese experience. J Radiat Res. 2019 Jul 1;60(4):501-508. doi: 10.1093/jrr/rrz016. |
| 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 |