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Completed

NCT Number: NCT01918124

A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer

This phase II clinical trial was designed to assess the feasibility, safety, toxicity, recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant radiation for patients with high-risk endometrial cancer.

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Key information

Conditions

Prosthesis Survival Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prosthesis Failure

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients must have had a hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) or modified radical hysterectomy or radical hysterectomy and bilateral salpingo-oophorectomy no more than 8 weeks prior to start of radiation therapy.

Additional surgical staging procedures are permissible but not required.

  • Risk factors: patients must fit one of the following:
  • Pelvic lymph node metastases
  • Paraaortic lymph node metastases
  • Grade 3 with myometrial invasion >50%
  • With stromal invasion of cervix
  • Known extrauterine disease (excluding second primary) confined to the pelvis.
  • High risk pathological type include: uterine papillary serous carcinoma, clear cell carcinoma, squamous cell carcinoma, undifferentiated carcinoma,
  • No known gross residual disease, or distant metastases.
  • Eastern Cooperative Oncology Group (ECOG) score<=2; Age 18~75.
  • White Blood Cell (WBC)≥4000/mm3, granulocytes ≥1500/mcl, platelets≥100,000/mcl.
  • Acceptable hepatic and renal function: creatinine <=1.4 mg%, bilirubin and serum glutamate oxaloacetate transaminase (SGOT) <=2*normal.
  • No medical contraindications to chemotherapy, or radiation therapy.
  • Study-specific signed informed consent.

Exclusion criteria

  • Prior pelvic radiation therapy.
  • Positive peritoneal cytology only for stage IIIa (FIGO 1998).
  • With history of other malignancies less than 5 years.
  • With gross residual disease, or distant metastases.
  • With endometrioid endometrial carcinoma and no risk factors:
  • with myometrial invasion <50%
  • Grade 1~2, with myometrial invasion >50%
  • With serious internal diseases which affect designed treatment
  • With psychotic disorders

Treatment and study plan

Radiotherapy

Radiation

Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.

Cisplatin

Drug

Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.

Cisplatin and Doxorubicin and Cyclophosphamide

Drug

Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.

Paclitaxel and Carboplatin

Drug

Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.

Primary outcomes

  1. Disease Free Survival(DFS)

    Time frame: From date of randomization until the date of first documented progression, assedded up to 60 months

    From date of randomization until the date of first documented progression, assessed up to 60 months.

Secondary outcomes

  1. Overall Survival (OS)

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

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

Other outcomes

  1. Number of patients with adverse events and number of patients completed the treatments

    Time frame: up to 5 years

    Number of patients completed the treatment and number of patients with adverse events up to 5 years.

Sponsors and collaborators

Lead sponsor

Fan Ming

Other

Registry information

Official study title

A Phase II Clinical Trial of Adjuvant Postoperative Irradiation Combined With Paclitaxel/Carboplatin(TP) or Cisplatin/Doxorubicin/Cyclophosphamide (CAP) Chemotherapy for Patients With High-risk Endometrial Cancer

Acronym: EC-0701

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Aug 7, 2013
Registry last updated
Oct 12, 2018

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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