Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

Sponsor

Mei Shi (Other)

Overall Status

Unknown status

CT.gov ID

NCT01999933

Collaborator

(none)

600

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Toxicity Due to Radiotherapy	Radiation: Radiation Drug: cisplatin（DDP） weekly Drug: docetaxel plus cisplatin Drug: docetaxel plus cisplatin	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

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
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

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

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

Outcome Measures

Primary Outcome Measures

overall survival [5-years]

Secondary Outcome Measures

disease-free survival [5 years]
acute adverse events [3 months]
chronic adverse events [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

Mei Shi

Investigators

Principal Investigator: Mei Shi, MD, department of radiation oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mei Shi, Director and Professor of Department of Radiation Oncology, Xijing Hospital, Air Force Military Medical University, China

ClinicalTrials.gov Identifier:

NCT01999933

Other Study ID Numbers:

XJFL-201309-CCPOSTOP

First Posted:

Dec 3, 2013

Last Update Posted:

Dec 3, 2013

Last Verified:

Nov 1, 2013

Keywords provided by Mei Shi, Director and Professor of Department of Radiation Oncology, Xijing Hospital, Air Force Military Medical University, China

Cervical cancer

postoperative risk factor

treatment

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Cisplatin

Docetaxel

Study Results

No Results Posted as of Dec 3, 2013