Surgery or Chemotherapy in Recurrent Ovarian Cancer (SOC 1 Trial)?

Primary Peritoneal Carcinoma Clinical Trial

Official title:

Evaluation of Secondary Cytoreductive Surgery in Platinum-Sensitive Recurrent Ovarian Cancer: A Phase III, Multicenter, Randomized Trial

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
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Ovarian Epithelial
• Fallopian Tube Carcinoma
• Ovarian Epithelial Cancer Recurrent
• Ovarian Neoplasms
• Primary Peritoneal Carcinoma

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

External Links

•   Shanghai Gynecologic Oncology Group