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Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

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ClinicalTrials.gov Identifier: NCT01999933
Recruitment Status : Unknown
Verified November 2013 by Mei Shi, Fourth Military Medical University.
Recruitment status was:  Recruiting
First Posted : December 3, 2013
Last Update Posted : December 3, 2013
Sponsor:
Information provided by (Responsible Party):
Mei Shi, Fourth Military Medical University

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5-years ]

Secondary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years ]
  2. acute adverse events [ Time Frame: 3 months ]
  3. chronic adverse events [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01999933


Contacts
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Contact: Mei Shi, MD.PhD +86-029-84775425 mshifmmu@yahoo.com

Locations
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China, Shaanxi
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Mei Shi, MD    +86-029-84775425    mshifmmu@yahoo.com   
Principal Investigator: Mei Shi, MD         
Sub-Investigator: Li-Chun Wei, M.D.,Ph.D         
Sponsors and Collaborators
Mei Shi
Investigators
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Principal Investigator: Mei Shi, MD department of radiation oncology

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Responsible Party: Mei Shi, Director and Professor of Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01999933     History of Changes
Other Study ID Numbers: XJFL-201309-CCPOSTOP
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: December 3, 2013
Last Verified: November 2013

Keywords provided by Mei Shi, Fourth Military Medical University:
Cervical cancer
postoperative risk factor
treatment

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action