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Cervical CancerPhase 4NCT04819685

Application of KANG FU PEN in Radical Concurrent Radiotherapy and Chemotherapy for Cervical Cancer to Prevent and Treat Radiation-induced Rectal Injury

A Phase 4 study testing KANG FU PEN in people with Cervical Cancer and Radiotherapy Side Effect, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
What is being tested?
KANG FU PEN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
520 participants
Where
1 siteChina
Study dates
1 Mar 2021to 1 Mar 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient is completely voluntary and has the ability to sign the research informed consent form within 30 days before enrollment;
  • Age ≥18 years old and ≤65 years old;
  • Pathologically confirmed cervical cancer;
  • Those with IB3, IIA2, IIB, IIIA, IIIB, and those with cervical tumor ≥ 4cm or involved parametrial in IIIC1 and IIIC2 (FIGO 2018 staging);
  • ECOG score 0-2 points;
  • 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;
  • Those who have had regular bowel movements and had a negative stool routine test + occult blood before enrollment.

Who cannot join

  • Those who have a history of allergy to superoxide dismutase use;
  • Patients with skin and mucous membrane infections, patients with obvious empyema or pelvic inflammatory disease;
  • Those who have had chronic colitis, ulcerative colitis, and non-specific proctitis in the past;
  • Those who have received cervical cancer surgery (including pelvic or retroperitoneal lymphadenectomy, excluding tumor biopsy), radiotherapy or chemotherapy;
  • 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;
  • Those who need to use fluorouracil or capecitabine or tigio in the concurrent chemotherapy regimen;
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  • History of other malignant tumors;
  • Pregnant or lactating women;
  • Accompanied by active infection and fever;
  • 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.

Trial locations and contacts

1 site in 1 country.

Fuquan Zhang, MD contact

+86 010 6915 5485

zhangfuquan3@126.com

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
KANG FU PEN
Medical subject headings
Uterine Cervical Neoplasms, Radiation Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KANG FU PENDrug

    FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays

Study groups in NCT04819685
Study groupRoleWhat they receive
test groupExperimentalIntervention:Anti-radiation spray (liquid dressing)
Receives: Drug: KANG FU PEN
control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 1 week after radiotherapy

Secondary outcomes (4)

  1. 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.

    Measured: 3 to 24 months after radiotherapy

  2. Quality of life score

    EORTC QLQ-C30 (V3.0) was used to score quality of life before, during, and after radiotherapy.

    Measured: 3 to 24 months after radiotherapy

  3. 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.

    Measured: 3 years after radiotherapy

  4. 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.

    Measured: 3 years after radiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2021
  2. Study start1 Mar 2021
  3. Primary completion1 Mar 2023 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
520 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04819685
Sponsor's protocol ID
KFP for RTI rectal injury
Status last verified
Mar 2021
First submitted
17 Mar 2021
Last updated
29 Mar 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38705489

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing KANG FU PEN in people with Cervical Cancer and Radiotherapy Side Effect, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fuquan Zhang, MD (+86 010 6915 5485, zhangfuquan3@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Degree of rectal mucosal injury caused by acute radiation (time frame: Within 1 week after radiotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819685, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2021.

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