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Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

Primary Purpose

Cervical Cancer, Toxicity Due to Radiotherapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiation
cisplatin（DDP） weekly
docetaxel plus cisplatin
docetaxel plus cisplatin
Sponsored by
Mei Shi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring Cervical cancer, postoperative risk factor, treatment

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 Years to 70 Years
  • Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
  • Accepted radical hysterectomy 3-4 weeks before
  • Karnofsky score >70
  • Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.
  • Examination results showed no radiation or chemotherapy contraindication
  • Willing to accept treatment
  • Ability to comply with trial requirements

Exclusion Criteria:

  • Postoperative residual
  • Postoperative recurrence or metastasis
  • Without lymph node dissection
  • Postoperative pathology showed aortic lymph node metastasis
  • Examination results showed radiotherapy contraindications
  • No indications for radiotherapy

Sites / Locations

  • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

CCRT with cisplatin(DDP) weekly

CCRT with TP

concurrent and adjuvant TP

Arm Description

concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation

concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation

2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease-free survival
acute adverse events
chronic adverse events

Full Information

First Posted
November 26, 2013
Last Updated
December 2, 2013
Sponsor
Mei Shi
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1. Study Identification

Unique Protocol Identification Number
NCT01999933
Brief Title
Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer
Official Title
Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mei Shi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.
Detailed Description
To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Toxicity Due to Radiotherapy
Keywords
Cervical cancer, postoperative risk factor, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCRT with cisplatin(DDP) weekly
Arm Type
Active Comparator
Arm Description
concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation
Arm Title
CCRT with TP
Arm Type
Experimental
Arm Description
concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation
Arm Title
concurrent and adjuvant TP
Arm Type
Experimental
Arm Description
2 cycles of concurrent TP, docetaxel plus cisplatin tri-weekly (75mg/m2),begin with radiation; and 4 cycles of adjuvant TP, the same regimen, after radiation
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.
Intervention Type
Drug
Intervention Name(s)
cisplatin（DDP） weekly
Intervention Description
concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation
Intervention Type
Drug
Intervention Name(s)
docetaxel plus cisplatin
Intervention Description
concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation
Intervention Type
Drug
Intervention Name(s)
docetaxel plus cisplatin
Intervention Description
adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5-years
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
5 years
Title
acute adverse events
Time Frame
3 months
Title
chronic adverse events
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 Years to 70 Years Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy Accepted radical hysterectomy 3-4 weeks before Karnofsky score >70 Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included. Examination results showed no radiation or chemotherapy contraindication Willing to accept treatment Ability to comply with trial requirements Exclusion Criteria: Postoperative residual Postoperative recurrence or metastasis Without lymph node dissection Postoperative pathology showed aortic lymph node metastasis Examination results showed radiotherapy contraindications No indications for radiotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Shi, MD.PhD
Phone
+86-029-84775425
Email
mshifmmu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
Organizational Affiliation
department of radiation oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
Phone
+86-029-84775425
Email
mshifmmu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
First Name & Middle Initial & Last Name & Degree
Li-Chun Wei, M.D.,Ph.D

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

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