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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT03146039 -
Non-Invasive Cervical Cancer Radiotherapy for Stage IB-IVB
|
Phase 2 | |
| Completed |
NCT03339765 -
Self-Advocacy Serious Game in Advanced Cancer
|
N/A |