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Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

NCT ID: NCT01999933

Last Updated: 2013-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Cervical Cancer Toxicity Due to Radiotherapy

Keywords

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Cervical cancer postoperative risk factor treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CCRT with cisplatin(DDP) weekly

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

Group Type ACTIVE_COMPARATOR

Radiation

Intervention Type RADIATION

Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.

cisplatin（DDP） weekly

Intervention Type DRUG

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

CCRT with TP

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

Group Type EXPERIMENTAL

Radiation

Intervention Type RADIATION

Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.

docetaxel plus cisplatin

Intervention Type DRUG

concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation

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

Group Type EXPERIMENTAL

Radiation

Intervention Type RADIATION

Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.

docetaxel plus cisplatin

Intervention Type DRUG

concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation

docetaxel plus cisplatin

Intervention Type DRUG

adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation

Interventions

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Radiation

Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.

Intervention Type RADIATION

cisplatin（DDP） weekly

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

Intervention Type DRUG

docetaxel plus cisplatin

concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation

Intervention Type DRUG

docetaxel plus cisplatin

adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mei Shi

OTHER

Sponsor Role lead

Responsible Party

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Mei Shi

Director and Professor of Department of Radiation Oncology, Xijing Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mei Shi, MD

Role: PRINCIPAL_INVESTIGATOR

department of radiation oncology

Locations

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Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mei Shi, MD.PhD

Role: CONTACT

Phone: +86-029-84775425

Email: [email protected]

Facility Contacts

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Mei Shi, MD

Role: primary

Other Identifiers

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XJFL-201309-CCPOSTOP

Identifier Type: -

Identifier Source: org_study_id