Ovarian Epithelial Cancer Recurrent, Fallopian Tube Carcinoma, Primary Peritoneal Carcinoma
Conditions
Keywords
secondary cytoreductive surgery, Ovarian Cancer, surgery, recurrence
Brief summary
The purpose of this study is to evaluate the role of secondary cytoreduction (SCR) and validate the risk model of patient selection criteria in platinum-sensitive recurrent ovarian cancer.
Detailed description
The primary objective is to determine whether secondary cytoreduction followed by chemotherapy is superior to chemotherapy alone in improving progression-free survival (PFS) and overall survival (OS) in patients with platinum-sensitive recurrent ovarian cancer
Interventions
PROCEDURESecondary Cytoreductive Surgery
Complete Cytoreduction
6 cycles of postoperative chemotherapy
Sponsors
Fudan University
Zhejiang Cancer Hospital
Shanghai Zhongshan Hospital
Sun Yat-sen University
Shanghai Gynecologic Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age at recurrence ≥ 18 years * Patients with platinum-sensitive, first relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer (EOC, PPC, FTC), which is defined as those with treatment -free interval of 6 months or more. * A complete secondary cytoreduction predicting score, iMODEL \[Tian WJ, Ann Surg Oncol 2012,19(2):597-604\]\<=4.7, including FIGO stage (0 or 0.8); residual disease after primary surgery (0 or 1.5); Progression-free interval (0 or 2.4); PS ECOG (0 or 2.4); Ca125 (0 or 1.8); and ascites at recurrence (0 or 3.0). If PI and CO-PI reach consensus that the recurrent tumor detected by PET/CT could be completely resected, the index of CA125 could be scored as 0. (Revised on 09/30/2013) * Assessed by the experienced surgeons, complete resection of all recurrent disease is possible. If single lesion outside the peritoneal cavity can be resected, MRI/CT or PET/CT scan should be performed to exclude simultaneous intra-abdominal lesions. * Patients who have given their signed and written informed consent and their consent.
Exclusion criteria
* Patients with borderline tumors as well as non-epithelial tumors. * Patients for interval-debulking, or for second-look surgery, or palliative surgery planned. * Impossible to assess the resectability or evaluate the score. Radiological signs suggesting complete resection is impossible. * More than one prior chemotherapy. * Second relapse or more * Patients with second or other malignancies who have been treated by surgery, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected. * Progression during chemotherapy or recurrence within 6 months after first-line therapy * Any contradiction not allowing surgery and/or chemotherapy 1. Accompanied by hypoxia serious chronic obstructive pulmonary disease 2. Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine. 3. Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency 4. Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy. 5. Uncontrolled diabetes 6. Uncontrolled epilepsy need long-term antiepileptic treatment. * Any medication induced considerable risk of surgery, e.g. estimated bleeding due to oral anticoagulating agents, or bevacizumab.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | Up to 60 months after last patient randomized | from date of randomisation until death |
| Progression-free survival | Up to 24 months after last patient randomized | interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accumulating Treatment-free survival (TFSa) | Up to 60 months after last patient randomized | the time of OS minus each treatment period after randomization, including surgery and chemotherapy |
| Overall survival after the adjustment of one-way treatment switching | Up to 60 months after last patient randomized | OS adjusted by statistical models for crossover |
| 30-day post-operative complications | From the operation until after 30 days | MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications |
| Validation of iMODEL | From randomization to operation | iMODEL score to predict complete resection |
| Time to first subsequent anticancer therapy | Up to 60 months after last patient randomized | From date of randomization until the date of first recurrent anticancer therapy |
| Time to second subsequent anticancer therapy | Up to 60 months after last patient randomized | From date of randomization until the date of secondary recurrent anticancer therapy |
| Quality of life assessments | Study entry; 6 months; 12 months; 24 months and 60 months after randomization | The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O) |
| Patient compliance | Up to 60 months after last patient randomized | compliance with protocol |
Countries
China
Outcome results
None listed