Clinical trial NCT05690906: Evaluate the Effect of ReSpace™ Hydrogel on Reducing Rectal Radiation Dose in Radiotherapy for Cervical Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Uterine Cervical Neoplasms
Keywords: Cervical Cancer
Hydrogel Spacer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The cumulative D2cc dose for rectum during brachytherapy
timeFrame: during procedure
Secondary outcomes:
measure: The cumulative D0.1cc, D5cc dose for rectum, and D0.1cc, D2cc, D5cc for sigmoid colon/small bowel during brachytherapy
timeFrame: during procedure
measure: The implantation success rate of hydrogel.
timeFrame: during procedure
measure: The stability of ReSpace™ Hydrogel
timeFrame: during procedure
measure: QLQ-C30
timeFrame: during procedure
measure: QLQ-CX24
timeFrame: during procedure
measure: Evaluation of device performance of hydrogel spacer
timeFrame: during procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.