Clinical trial · Interventional
Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer
A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Clinical Study to Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer
NCT05690906CI-TRIAL-00067828unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gauze packing | Device | — | UNRESOLVED |
| ReSpace™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ReSpace™ & gauze packing
- description
- All of the subjects will undergo palcement of ReSpace™ hydrogel together with gauze packing in the vagina before brachytherapy
- interventionNames
- Device: ReSpace™
- Device: gauze packing
- type
- ACTIVE_COMPARATOR
- label
- gauze packing
- description
- All of the subjects will undergo palcement of gauze packing alone in the vagina before brachytherapy
- interventionNames
- Device: gauze packing
Primary outcomes (1)
- measure
- The cumulative D2cc dose for rectum during brachytherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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. * Karnofsky score ≥ 70. * Subjects aged ≥ 18 years and ≤ 75 years. * Subjects must be able to cooperate in completing the entire study. * The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI. * No contraindications to CT scanning. * Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form Exclusion Criteria: * •Subjects who have received prior pelvic radiotherapy. * Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.) * Subjects with other primary malignancies * Subjects with contraindications to radiotherapy, as determined by the investigators * Subjects with injection site infections. * Subjects who are allergic to the ingredients of the device. * Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators * Persons with severe mental illness, cognitive impairment and thinking disorders. * Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening * Pregnant or lactating women or those who plan to get pregnant within the last six months * Subjects who cannot be followed up as prescribed by the doctor * Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen
References
Publications (4)
- BACKGROUNDde 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. PMID 22484226
- BACKGROUNDPeach 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. PMID 30237814
- BACKGROUNDKashihara 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. PMID 31034570
- DERIVEDWang Y, Zhang X, Wang F, Chen W, Cao X, Ou Y, Zhang Z, Ke G, Liu Z, Wang T, Xie P, Guo Q, Zhang W, Zhai J, Li G, Pan Z, Hou S, Zhang Z, Wang Y, Yan J, Qiu J, Zhang F. Dosimetric and Clinical Effects of Polyethylene Glycol Gel in Radical Concurrent Chemoradiation Therapy for Cervical Cancer: A Phase 3 Prospective Multicenter Randomized Controlled Trial. Int J Radiat Oncol Biol Phys. 2026 Feb 1;124(2):349-358. doi: 10.1016/j.ijrobp.2025.08.045. Epub 2025 Aug 26. PMID 40876576