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

NCT01918124 | Completed Phase 2 DMC

• 1 other identifier: 070148-7
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prosthesis Survival

Keywords

disease free survival, overall survival

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival(DFS)

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

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

Secondary Outcomes (1)

• Overall Survival (OS)

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

Other Outcomes (1)

• Number of patients with adverse events and number of patients completed the treatments

  up to 5 years

Study Arms (1)

radiotherapy combined with chemotherapy

EXPERIMENTAL

Arm Label: radiotherapy combined with chemotherapy: Radiotherapy: 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: Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy. Cisplatin and Doxorubicin and Cyclophosphamide： Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) given at 3 week intervals following completion of radiotherapy. Paclitaxel and Carboplatin： Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.

Radiation: radiotherapy; Drug: Cisplatin; Drug: Cisplatin and Doxorubicin and Cyclophosphamide; Drug: Paclitaxel and Carboplatin

Interventions

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.

radiotherapy combined with chemotherapy

Cisplatin DRUG

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

radiotherapy combined with chemotherapy

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.

radiotherapy combined with chemotherapy

Paclitaxel and Carboplatin DRUG

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

radiotherapy combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fan Ming: lead

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• Ren Y, Huang X, Shan B, Wu X, Huang X, Shi D, Wang H. Adjuvant concurrent chemoradiation followed by chemotherapy for high-risk endometrial cancer. Gynecol Oncol. 2016 Jan;140(1):58-63. doi: 10.1016/j.ygyno.2015.11.021. Epub 2015 Nov 24.

  PMID: 26607778 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Prosthesis Failure

Interventions

Radiotherapy; Cisplatin; Doxorubicin; Cyclophosphamide; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Huaying Wang, Doctor

  Shanghai Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai Cancer Center

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: August 7, 2013
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

CN (1)