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

Primary Purpose

Cervical Cancer, Radiotherapy Side Effect, Radiotherapy; Complications

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

KANG FU PEN

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

test group

control group

Arm Description

Intervention:Anti-radiation spray (liquid dressing)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Quality of life score

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

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.

Full Information

NCT ID

NCT04819685

First Posted

March 17, 2021

Last Updated

March 26, 2021

Sponsor

Peking Union Medical College Hospital

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking University Third Hospital, Peking University Cancer Hospital & Institute, Jiangsu Cancer Institute & Hospital, Sichuan Cancer Hospital and Research Institute, Sun Yat-sen University, Jilin Provincial Tumor Hospital, Fudan University, Shandong Cancer Hospital and Institute, Xijing Hospital Attached Air Force Medical University, Guizhou Cancer Hospital (The Affiliated Cancer Hospital of Guizhou Medical University), Zhejiang Cancer Hospital, Xiangya Hospital of Central South University, Henan Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04819685

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2021 (Actual)

Primary Completion Date

March 1, 2023 (Anticipated)

Study Completion Date

March 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Radiotherapy Side Effect, Radiotherapy; Complications

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

test group

Arm Type

Experimental

Arm Description

Intervention:Anti-radiation spray (liquid dressing)

Arm Title

control group

Arm Type

No Intervention

Intervention Type

Drug

Intervention Name(s)

KANG FU PEN

Intervention Description

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

Primary Outcome Measure Information:

Title

Degree of rectal mucosal injury caused by acute radiation

Description

the incidence of Vienna rectoscopy score ≥2 within 1 week after radiotherapy. Vienna rectoscopy score was used.

Time Frame

Within 1 week after radiotherapy

Secondary Outcome Measure Information:

Title

Degree of rectal injury caused by chronic radiation

Description

Time Frame

3 to 24 months after radiotherapy

Title

Quality of life score

Description

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

Time Frame

3 to 24 months after radiotherapy

Title

overall survival (OS)

Description

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.

Time Frame

3 years after radiotherapy

Title

disease-progression-free survival (PFS)

Description

Time Frame

3 years after radiotherapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fuquan Zhang, MD

Phone

+86 010 6915 5485

zhangfuquan3@126.com

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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