Chemotherapy vs Chemoradiotherapy for Post-operative Endometrial Cancer Patients With P53-mutation

NCT05489848 | Not Yet Recruiting Phase 2

• 1 other identifier: EC-2022 -01
• Study Type: interventional
• Target: 294
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim to compare chemotherapy alone or chemoradiotherapy for post-operative endometrial cancer (stage I-IVA) with p53 mutation.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• the 2-year progression-free survival(PFS)

  The percentage of patients who have first relapse within 2 years after surgery.

  2 years

Secondary Outcomes (2)

• the 3-year PFS

  3 years

• the 5-year PFS and Overall survival(OS)

  5 years

Other Outcomes (4)

• Incidence of adverse events

  From date of recruitment, assessed up to 1 month after treatment.

• Quality of life change

  baseline, 6 months, 12 months

• Medical expenses

  5 years

Study Arms (2)

Arm1: Chemotherapy group

EXPERIMENTAL

Paclitaxel plus carboplatin (TC) regimen, intravenous chemotherapy. Once every three weeks with total of 6 cycles.

Drug: Paclitaxel; Drug: Carboplatin

Arm2: Radiotherapy plus chemotherapy group

ACTIVE COMPARATOR

Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT. Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT. Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease \<2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT. Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.

Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Radiation: EBRT; Radiation: VBT

Interventions

Paclitaxel DRUG

Paclitaxel: paclitaxel dose of 135\~175mg / m2, about 3 hours after the infusion, the use of pretreatment drugs before the infusion according to the drug instructions. Every 21 days is one session.

Arm1: Chemotherapy group; Arm2: Radiotherapy plus chemotherapy group

Carboplatin DRUG

Carboplatin: Doses were given at AUC=5 - 6 and used after paclitaxel. Based on the calculated amount, the maximum dose of carboplatin per chemotherapy does not exceed 750mg.

Arm1: Chemotherapy group; Arm2: Radiotherapy plus chemotherapy group

Cisplatin DRUG

Concurrent cisplatin intravenous chemotherapy on radiotherapy days 1 and 29,50mg / m2, a total of 2 times.

Arm2: Radiotherapy plus chemotherapy group

EBRT RADIATION

50.4Gy/28 / 6 weeks; common iliac node positive or paraaortic node positive plus extended field.The radiation extension field should include the entire pelvic cavity, the common iliac vessels and the paraaortic lymph node area.The range above the extension field is determined based on the clinical status, but at least 1-2cm above the renal vascular level.

Arm2: Radiotherapy plus chemotherapy group

VBT RADIATION

Subnormal vaginal mucosa was 0.5cm, 30Gy / 5times /5weeks.

Arm2: Radiotherapy plus chemotherapy group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• )Age ≥18 years,
• \) Patients with stage I-IVA (FIGO2009) (excluded endometrial epithelial carcinoma confined to the endometrial layer), which have received initial diagnosis and comprehensive staging surgery (based on total uterine and double salpingectomy. Lymph nodes are evaluated by at least a sentinel lymph node biopsy), regardless of the pathological type, at the same time, the molecular typing of preoperative endometrial biopsy or total hysterectomy should be type p53mut.
• )The duration of postoperative adjuvant therapy after initiation shall not exceed 8 weeks after enrollment,
• )There is no obvious abnormality in the function of important organs, and the relevant test values meet the following requirements:
• A. White blood cell count ≥3×109/L or absolute value of neutrophile granulocyte ≥ 1.5×109/L,
• B. Platelet count ≥ 100× 109/L,
• C. AST and/or ALT\<2.5 times the upper limit of normal value,
• D. Serum creatinine \< 2 times the upper limit of normal value,
• E. Physical fitness score: Karnofsky(KPS) score ≥60, The Eastern Cooperative Oncology Group(ECOG) score is ≤2 points.

You may not qualify if:

• \) Tumors from uterine stroma,
• \) Recurrent endometrial malignant tumor,
• \) Those who have received other anti-tumor treatments within half a year before surgery: including neoadjuvant chemotherapy, hormone therapy, target therapy, immunotherapy, and biological therapy,etc.
• \) Those in pregnancy and perinatal period,
• \) Concurrent with other malignant tumors of reproductive system or non-reproductive system,
• \) History of important organ transplantation,
• \) Those who need to take immunosuppressants with a history of immune diseases,
• \) History of severe mental illness and brain dysfunction,
• \) History of drug abuse or drug use,
• \) Participants in other clinical trials at the same time,
• \) Those who are unable or unwilling to receive postoperative adjuvant chemotherapy or radio-chemotherapy/sign the informed consent form/comply with the research requirements,
• \) Patients of any stage who are excluded or unable to tolerate radiotherapy and chemotherapy after evaluation without indication of radiotherapy.

Sponsors & Collaborators

• Fudan University: lead

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Paclitaxel; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yulan Ren

  Fudan University

  PRINCIPAL INVESTIGATOR

• Huaying Wang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulan Ren

CONTACT

18017312918; yulan_ren@shca.org.cn

Huaying Wang

CONTACT

+86-18017312207; wanghuaying270@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 5, 2022
• Study Start: August 20, 2022
• Primary Completion (Estimated): August 20, 2028
• Study Completion (Estimated): August 20, 2030
• Last Updated: August 5, 2022

Record last verified: 2022-08