Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

NCT01999933 | Unknown Phase 2 DMC

• 1 other identifier: XJFL-201309-CCPOSTOP
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Toxicity Due to Radiotherapy

Keywords

Cervical cancer; postoperative risk factor; treatment

Outcome Measures

Primary Outcomes (1)

• overall survival

  5-years

Secondary Outcomes (3)

• disease-free survival

  5 years

• acute adverse events

  3 months

• chronic adverse events

  3 years

Study Arms (3)

CCRT with cisplatin(DDP) weekly

ACTIVE COMPARATOR

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

Radiation: Radiation; Drug: cisplatin（DDP） weekly

CCRT with TP

EXPERIMENTAL

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

Radiation: Radiation; Drug: docetaxel plus cisplatin

concurrent and adjuvant TP

EXPERIMENTAL

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; Drug: docetaxel plus cisplatin

Interventions

Radiation RADIATION

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

CCRT with TP; CCRT with cisplatin(DDP) weekly; concurrent and adjuvant TP

cisplatin（DDP） weekly DRUG

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

CCRT with cisplatin(DDP) weekly

docetaxel plus cisplatin DRUG

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

CCRT with TP; concurrent and adjuvant TP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mei Shi: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiation; Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Mei Shi, MD

  department of radiation oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei Shi, MD.PhD

CONTACT

+86-029-84775425; mshifmmu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and Professor of Department of Radiation Oncology, Xijing Hospital

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2018
• Last Updated: December 3, 2013

Record last verified: 2013-11

Locations

CN (1)