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

Phase 3

• Conditions: Primary Peritoneal Carcinoma; Fallopian Tube Carcinoma; Ovarian Epithelial Cancer Recurrent
• Interventions: Procedure: Secondary Cytoreductive Surgery; Drug: Salvage Chemotherapy

• Registration Number: NCT01611766
• Lead Sponsor: Shanghai Gynecologic Oncology Group

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

Study Timeline

• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-05
• Study Start: 2012-07-19
• Primary Completion: 2019-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-07
• Last Update Posted: 2021-06-10
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 356

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
secondary cytoreductive surgery	Secondary Cytoreductive Surgery	SCR followed by chemotherapy
secondary cytoreductive surgery	Salvage Chemotherapy	SCR followed by chemotherapy
Salvage Chemotherapy	Salvage Chemotherapy	platinum-based chemotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Validation of iMODEL	From randomization to operation	iMODEL score to predict complete resection
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
Patient compliance	Up to 60 months after last patient randomized	compliance with protocol
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)
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

Trial Locations

Locations (4)

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, China