Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?
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ClinicalTrials.gov Identifier: NCT01611766 |
Recruitment Status : Unknown
Verified June 2021 by Shanghai Gynecologic Oncology Group.
Recruitment status was: Active, not recruiting
First Posted : June 5, 2012
Last Update Posted : June 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Epithelial Cancer Recurrent Fallopian Tube Carcinoma Primary Peritoneal Carcinoma | Procedure: Secondary Cytoreductive Surgery Drug: Salvage Chemotherapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 356 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial |
Actual Study Start Date : | July 19, 2012 |
Actual Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: secondary cytoreductive surgery
SCR followed by chemotherapy
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Procedure: Secondary Cytoreductive Surgery
Complete Cytoreduction
Other Name: Maximum effort cytoreductive surgery Drug: Salvage Chemotherapy 6 cycles of postoperative chemotherapy
Other Name: second line chemotherapy |
Active Comparator: Salvage Chemotherapy
platinum-based chemotherapy
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Drug: Salvage Chemotherapy
6 cycles of postoperative chemotherapy
Other Name: second line chemotherapy |
- Overall survival [ Time Frame: Up to 60 months after last patient randomized ]from date of randomisation until death
- Progression-free survival [ Time Frame: 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
- Accumulating Treatment-free survival (TFSa) [ Time Frame: 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 [ Time Frame: Up to 60 months after last patient randomized ]OS adjusted by statistical models for crossover
- 30-day post-operative complications [ Time Frame: 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 [ Time Frame: From randomization to operation ]iMODEL score to predict complete resection
- Patient compliance [ Time Frame: Up to 60 months after last patient randomized ]compliance with protocol
- Quality of life assessments [ Time Frame: 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)
- Time to first subsequent anticancer therapy [ Time Frame: 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 [ Time Frame: Up to 60 months after last patient randomized ]From date of randomization until the date of secondary recurrent anticancer therapy
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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
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Any contradiction not allowing surgery and/or chemotherapy
- Accompanied by hypoxia serious chronic obstructive pulmonary disease
- Uncontrolled hypertension, cerebrovascular accident/ Stroke, myocardial infarct, unstable angina, untreated thrombosis, chronic congestive heart failure, or serious arrhythmia in need of medicine.
- Severe hepatitis, history of liver disease, nephrotic syndrome, renal insufficiency
- Active ulcer history, abdominal wall fistula, perforation of gastrointestinal tract, or Intra-abdominal abscess, or simultaneously apply treatment/prevent ulcers therapy.
- Uncontrolled diabetes
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611766
China, Guangdong | |
Sun Yat-sen University Cancer Center | |
Guangzhou, Guangdong, China, 510060 | |
China, Shanghai | |
Fudan University Cancer Hospital | |
Shanghai, Shanghai, China, 200032 | |
Shanghai Zhongshan Hospital | |
Shanghai, Shanghai, China, 200032 | |
China, Zhejiang | |
Zhejiang Cancer Hospital | |
Hangzhou, Zhejiang, China, 310022 |
Principal Investigator: | Rongyu Zang, MD,PhD | Shanghai Gynecologic Oncology Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shanghai Gynecologic Oncology Group |
ClinicalTrials.gov Identifier: | NCT01611766 |
Other Study ID Numbers: |
SGOG OV 2 SGOG OV2 ( Other Identifier: SGOG ) |
First Posted: | June 5, 2012 Key Record Dates |
Last Update Posted: | June 10, 2021 |
Last Verified: | June 2021 |
secondary cytoreductive surgery Ovarian Cancer surgery recurrence |
Carcinoma Ovarian Neoplasms Carcinoma, Ovarian Epithelial Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Disease Attributes Pathologic Processes Endocrine Gland Neoplasms Neoplasms by Site |
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders |