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NCT Number: NCT04453904

Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Endometrial cancer is the most common gynecological malignancy affecting women's health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jianliu Wang

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Jianliu Wang, Doctor

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients of primary treatment
  • All patients must have undertaken comprehensive staging operation（Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).
  • Patients with endometrial adenocarcinoma confirmed by postoperative patholog.
  • All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.
  • Entry into the study is limited to no more than 8 weeks from the date of surgery.
  • Patients with adequate organ function, reflected by the following parameters:
  • WBC ≥ Normal value of the institution;
  • Absolute neutrophil count (ANC) ≥ Normal value of the institution;
  • Platelet count ≥ 100,000/mcl;
  • SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;
  • Bilirubin ≤ 1.5 X ULN;
  • Creatinine ≤ institutional ULN.
  • Patients with a Karnofsky score≥60.
  • The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.

Exclusion criteria

  • Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).
  • Patients with residual tumor after surgery.
  • Patients with other invasive malignancies.
  • Patients with contraindications of radiotherapy and chemotherapy (with a history of myocardial infarction within 3 month, unstable angina pectoris or history of uncontrolled arrhythmia s from the date of registration) and who cannot receive postoperative adjuvant radiotherapy and chemotherapy.
  • Patients with an estimated survival of less than 6 months.
  • Those who are unable or unwilling to comply with the research requirements

Treatment and study plan

sequential radiochemotherapy in a "sanwich" mode

Other

Patients will randomized into two different modalities of radiochemotherapy.

Primary outcomes

  1. Progress-free survival

    Time frame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months

    To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of recurrence or death (i.e., increases disease-free survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.

Secondary outcomes

  1. Overall survival

    Time frame: From the date of randomization until the date of death from any cause, assessed up to 60 months

    To determine if treatment with radiochemotherapy in "sanwich" mode (carboplatin and paclitaxel for 2 cycles, then radiotherapy, and then carboplatin and paclitaxel for 4 cycles)(experimental arm) reduces the rate of death (i.e., increases survival) when compared to concurrent cisplatin and radiation followed by carboplatin and paclitaxel for 4 cycles (control arm) in patients with stages III endometrial adenocarcinoma.

  2. adverse effect

    Time frame: through study completion,an average of 1 year

    To compare the modalities with respect to acute and late adverse effects of therapy.

  3. patient-reported Quality of Life

    Time frame: 3 months after treatment and 1 year after treatment

    To determine the impact on patient-reported Quality of Life (using the questionnaire of combining the items from FACT-G, FACT/GOG-NTX-4 subscale (4 items) and items C3 and C5 from the FACT-C)during and following treatment for up to 1 year with the two treatment regimens.

Study contacts

Contact information is provided by the study sponsor or research team.

Guo Zhang, Ph.D

CONTACT

[email protected]

+861088324381

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Jul 1, 2020
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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