Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer

Cervical Cancer Stage IVB Clinical Trial

Official title:

Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03175848
• Other study ID #: ZJCH-2017-CRT
• Status: Recruiting
• Phase: N/A
• First received: May 28, 2017
• Last updated: July 18, 2017
• Start date: May 5, 2017
• Est. completion date: October 31, 2020

Study information

• Verified date: May 2017
• Source: Zhejiang Cancer Hospital
• Contact: HanMei Lou, M.A.
• Phone: Telephone: 0086-571-88122038
• Email: louhanmei[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, single arm, phase II trail to assess the effect of primary lesion radiotherapy in the treatment of stage IVB cervical cancer on the basis of systemic chemotherapy.

Description:

Because of the apparent heterogeneity of stage IVB cervical cancer, at present there is no standard treatment.

This is a Phase II, single-center, single-arm, study of systemic chemotherapy plus lesion radiotherapy for primary stage IVB cervical cancer.

The primary objective of the study is to test the hypothesis that primary lesion radiotherapy leads to an improvement in progression-free survival time (PFS)for stage IVB cervical cancer.

For those patients under the clinical management of the recruiting investigator, the investigator will review the patient's medical records and determine if they would be a candidate for the study.

Upon confirmation of all eligibility criteria, the subject will be enrolled.Patients with beyond abdominal pelvic lymph node metastasis will first undergo 2 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC）.Distant metastasis of lymph node areas (e.g., supraclavicular, axillary, mediastinum, etc.) will be radiation after radiotherapy at the primary site according to patients tolerant.Patients with stage IVB cervical cancer with hematogenous metastasiswill first undergo 4 cycle systemic chemotherapy（TP/TC），then to evaluate the efficacy of chemotherapy, and for patients with chemotherapy effective（CR+PR+SD) followed by the primary lesion of regional radiotherapy (external irradiation plus brachytherapy)，concurrent chemotherapy （TP/TC） may be given according to the patients tolerant，finally, the patient will complete a total of 6 cycles of chemotherapy（TP/TC），after the primary radiotherapy, the treatment regimen for distant metastasis will be determined by MDT discuss or consultation.Quality of life will be evaluated before and after treatment. During therapy, the patient will have a weekly physical exam, vital signs collected, evaluation for pain, and review any side effects.

Subjects will undergo a post treatment follow-up period after completion of their radiation therapy. During this follow-up period, subjects will return for a medical and history review with a complete physical examination, review of any side effects, evaluation for outcomes and toxicity, and QoL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Biopsy-proven, invasive carcinoma of the cervix(squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma )

2. KPS=70

3. FIGO stage IVB

4. Age: 18-70

5. ECOG (Eastern Cooperative Oncology Group) : 0-2

6. The expected survival time is >6 months

7. Chemotherapy and radiation have not been done before

8. Normal hemodynamic indices before the recruitment (including white blood cell count>4.0×109/L, neutrophil count>1.5×109/L, platelet count >100×109/L, hemoglobin=90g/l, normal liver/kidney function)

9. Able to understand this study and have signed informed consent.

Exclusion Criteria:

1. Prior hysterectomy

2. Metastases lesions are confirmed by pathology or image and are excluded as the second primary neoplasm

3. Patients with brain metastasis or disseminated peritoneal metastasis

4. Female in pregnancy or lactating

5. Hypersensitivity of chemotherapeutic drugs (paclitaxel allergy)

6. History of major psychiatric disorder

7. Persons with physical or mental illness, without civil capacity or with limited capacity for civil conduct

8. Patient with any other disease or condition is a contraindication for chemoradiotherapy

9. The researchers consider the patient not appropriate to be enrolled

Related Conditions & MeSH terms

• Cervical Cancer Stage IVB
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Chemotherapy,radiotherapy
Pelvic,pelvic-inguinal,or extended field radiotherapy:Therapy 45 - 50 Gy in 1.7 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks for PTV Brachytherapy: Therapy 5-6 fractions of 4-6Gy prescribed to the high-risk CTV or A piont.

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival time, PFS	Progression-free survival will be evaluated	2 years
Secondary	Number of Patients with Adverse Events as a Measure of Safety	To quantify rates of acute hematologic, gastrointestinal, and genitourinary toxicity	2 years
Secondary	Objective Response Rates, ORR	Objective Response Rates will be evaluated	2 years
Secondary	Overall survival	Overall survival will be evaluated	2 years
Secondary	Ranking Quality of Life of Patients	To measure health-related quality of life based on the cancer-specific EORTC-QLQ-C30 questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and cervical cancer module(CX24).	2 years
Secondary	Screening for potentially curable primary stage IVB cervical cancer	By follow-up data,screening for potentially curable primary stage IVB cervical cancer	2 years