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A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer (EC-0701)

Primary Purpose

Prosthesis Survival

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

radiotherapy

Cisplatin

Cisplatin and Doxorubicin and Cyclophosphamide

Paclitaxel and Carboplatin

About this trial

This is an interventional treatment trial for Prosthesis Survival focused on measuring disease free survival, overall survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiotherapy combined with chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease Free Survival(DFS)

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

Secondary Outcome Measures

Overall Survival (OS)

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

Full Information

NCT ID

NCT01918124

First Posted

July 29, 2013

Last Updated

October 10, 2018

Sponsor

Fan Ming

1. Study Identification

Unique Protocol Identification Number

NCT01918124

Brief Title

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

Acronym

EC-0701

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

January 2008 (Actual)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Fan Ming

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prosthesis Survival

Keywords

disease free survival, overall survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

radiotherapy combined with chemotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cisplatin and Doxorubicin and Cyclophosphamide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel and Carboplatin

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease Free Survival(DFS)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

up to 5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huaying Wang, Doctor

Organizational Affiliation

Shanghai Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Cancer Center

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200000

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

26607778

Citation

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.

Results Reference

derived

Links:

URL

http://www.shca.org.cn

Description

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

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