Clinical trial NCT03175848: Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer
Official title: Chemotherapy Plus Radiation Therapy in Treating Patients With Primary Stage IVB Cervical Cancer: A Prospective, Single Arm, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer Stage IVB
Keywords: Cervical Cancer
Radiotherapy
Chemotherapy
stage IVB cervical cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression-free survival time, PFS
timeFrame: 2 years
Secondary outcomes:
measure: Number of Patients with Adverse Events as a Measure of Safety
timeFrame: 2 years
measure: Objective Response Rates, ORR
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
measure: Ranking Quality of Life of Patients
timeFrame: 2 years
measure: Screening for potentially curable primary stage IVB cervical cancer
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: HanMei Lou, M.A.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: ZhuoMin Yin
role: PRINCIPAL_INVESTIGATOR
References: