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

  • STATUS
    Recruiting
  • End date
    Mar 1, 2025
  • participants needed
    520
  • sponsor
    Peking Union Medical College Hospital
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Updated on 8 April 2021
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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.

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 6Gy5 fractions, or 7Gy4 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.

Details
Condition Cervical Cancer, Cervical Cancer, Disorders of cervix NOS, Uterine Cancer, Uterine Cancer, Radiotherapy Side Effect, Effects of Radiation Therapy, cervical carcinoma, cervical cancer, uterine, carcinoma of the cervix uteri, carcinoma of the cervix, cervix cancer, cancer of the cervix, carcinoma of cervix, Radiotherapy; Complications, Radiotherapy; Complications
Treatment KANG FU PEN
Clinical Study IdentifierNCT04819685
SponsorPeking Union Medical College Hospital
Last Modified on8 April 2021

Eligibility

 Yes No Not Sure

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: NEUT1.5 _10^9/L, HGB80g/L, PLT100_ 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
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