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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01611766
Other study ID # SGOG OV 2
Secondary ID SGOG OV2
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 19, 2012
Est. completion date December 2022

Study information

Verified date June 2021
Source Shanghai Gynecologic Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 356
Est. completion date December 2022
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Secondary Cytoreductive Surgery
Complete Cytoreduction
Drug:
Salvage Chemotherapy
6 cycles of postoperative chemotherapy

Locations

Country Name City State
China Sun Yat-sen University Cancer Center Guangzhou Guangdong
China Zhejiang Cancer Hospital Hangzhou Zhejiang
China Fudan University Cancer Hospital Shanghai Shanghai
China Shanghai Zhongshan Hospital Shanghai Shanghai

Sponsors (5)

Lead Sponsor Collaborator
Shanghai Gynecologic Oncology Group Fudan University, Shanghai Zhongshan Hospital, Sun Yat-sen University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival from date of randomisation until death Up to 60 months after last patient randomized
Primary Progression-free survival interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first Up to 24 months after last patient randomized
Secondary Accumulating Treatment-free survival (TFSa) the time of OS minus each treatment period after randomization, including surgery and chemotherapy Up to 60 months after last patient randomized
Secondary Overall survival after the adjustment of one-way treatment switching OS adjusted by statistical models for crossover Up to 60 months after last patient randomized
Secondary 30-day post-operative complications MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications From the operation until after 30 days
Secondary Validation of iMODEL iMODEL score to predict complete resection From randomization to operation
Secondary Patient compliance compliance with protocol Up to 60 months after last patient randomized
Secondary Quality of life assessments The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O) Study entry; 6 months; 12 months; 24 months and 60 months after randomization
Secondary Time to first subsequent anticancer therapy From date of randomization until the date of first recurrent anticancer therapy Up to 60 months after last patient randomized
Secondary Time to second subsequent anticancer therapy From date of randomization until the date of secondary recurrent anticancer therapy Up to 60 months after last patient randomized
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