Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

Clinical Study on Docetaxel Plus Cisplatin(TP) Regimen Combined With Postoperative Radiotherapy for Stage Ia2- IIb Cervical Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer; Toxicity Due to Radiotherapy
• Intervention / Treatment: Radiation: Radiation; Drug: cisplatin（DDP） weekly; Drug: docetaxel plus cisplatin; Drug: docetaxel plus cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
      • Principal Investigator: Mei Shi, MD
      • Contact: Mei Shi, MD; Phone Number: +86-029-84775425; Email: mshifmmu@yahoo.com
      • Sub-Investigator: Li-Chun Wei, M.D.,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CCRT with cisplatin(DDP) weekly; concurrent chemotherapy: cisplatin（DDP） weekly, 40mg/m2, begin with radiation	Radiation: Radiation; Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.; Drug: cisplatin（DDP） weekly; concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation
Experimental: CCRT with TP; concurrent TP tri-weekly, docetaxel plus cisplatin tri-weekly (75mg/m2), begin with radiation	Radiation: Radiation; Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.; Drug: docetaxel plus cisplatin; concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation; Drug: docetaxel plus cisplatin; adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation
Experimental: concurrent and adjuvant TP; 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	Radiation: Radiation; Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.; Drug: docetaxel plus cisplatin; concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation; Drug: docetaxel plus cisplatin; adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	5-years

Secondary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	5 years
acute adverse events	3 months
chronic adverse events	3 years

Collaborators and Investigators

• Sponsor: Mei Shi

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 3, 2013

Study Record Updates

• Last Update Posted (Estimate): December 3, 2013
• Last Update Submitted That Met QC Criteria: December 2, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: treatment; Cervical cancer; postoperative risk factor
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: XJFL-201309-CCPOSTOP