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Ovarian Epithelial Cancer RecurrentPhase 3NCT01611766

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

A Phase 3 study testing Secondary Cytoreductive Surgery and Salvage Chemotherapy in people with Ovarian Epithelial Cancer Recurrent and Fallopian Tube Carcinoma, run by Shanghai Gynecologic Oncology Group at 4 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
What is being tested?
Secondary Cytoreductive Surgery and Salvage Chemotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
356 participants
Where
4 sitesChina
Study dates
19 Jul 2012to Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • Progression during chemotherapy or recurrence within 6 months after first-line therapy
  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Fudan University Cancer Hospital

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

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

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.

Read the 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

Being tested
Secondary Cytoreductive Surgery, Salvage Chemotherapy
Keywords
secondary cytoreductive surgery, Ovarian Cancer, surgery, recurrence
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Secondary Cytoreductive SurgeryProcedure or surgery

    Also called Maximum effort cytoreductive surgery

    Complete Cytoreduction

  • Salvage ChemotherapyDrug

    Also called second line chemotherapy

    6 cycles of postoperative chemotherapy

Study groups in NCT01611766
Study groupRoleWhat they receive
secondary cytoreductive surgeryExperimentalSCR followed by chemotherapy
Receives: Procedure: Secondary Cytoreductive Surgery; Drug: Salvage Chemotherapy
Salvage ChemotherapyActive comparatorplatinum-based chemotherapy
Receives: Drug: Salvage Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    from date of randomisation until death

    Measured: Up to 60 months after last patient randomized

  2. Progression-free survival

    interval between date of randomization and the date of second relapse/ progression or death, whatever occurs first

    Measured: Up to 24 months after last patient randomized

Secondary outcomes (8)

  1. Accumulating Treatment-free survival (TFSa)

    the time of OS minus each treatment period after randomization, including surgery and chemotherapy

    Measured: Up to 60 months after last patient randomized

  2. Overall survival after the adjustment of one-way treatment switching

    OS adjusted by statistical models for crossover

    Measured: Up to 60 months after last patient randomized

  3. 30-day post-operative complications

    MSKCC surgical complications grading method and CTCAE v4.03 criteria will be adopted for evaluating the perioperative complications

    Measured: From the operation until after 30 days

  4. Validation of iMODEL

    iMODEL score to predict complete resection

    Measured: From randomization to operation

  5. Patient compliance

    compliance with protocol

    Measured: Up to 60 months after last patient randomized

  6. Quality of life assessments

    The EORTC core quality of life questionnaire (QLQ-C30, version 3.0) Functional Assessment of Cancer Therapy- Ovary (FACT-O)

    Measured: Study entry; 6 months; 12 months; 24 months and 60 months after randomization

  7. Time to first subsequent anticancer therapy

    From date of randomization until the date of first recurrent anticancer therapy

    Measured: Up to 60 months after last patient randomized

  8. Time to second subsequent anticancer therapy

    From date of randomization until the date of secondary recurrent anticancer therapy

    Measured: Up to 60 months after last patient randomized

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2012 (estimated)
  2. Study start19 Jul 2012
  3. Primary completionDec 2019
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
356 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01611766
Sponsor's protocol ID
SGOG OV 2
Other IDs
SGOG OV2
Status last verified
Jun 2021
First submitted
30 May 2012
Last updated
10 Jun 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Jiang R, Feng Y, Chen Y, Cheng X, Shi T, Gao W, Jia H, Jiang S, Guo Y, Huang X, Tu D, Zhang Y, Yang H, Zhang P, Liu J, Zhu J, Zang R; SOC-1 Investigators. Surgery versus no surgery in platinum-sensitive relapsed ovarian cancer: final overall survival analysis of the SOC-1 randomized phase 3 trial. Nat Med. 2024 Aug;30(8):2181-2188. doi: 10.1038/s41591-024-02981-0. Epub 2024 Jun 1.

    PubMed 38824243

  • Shi T, Zhu J, Feng Y, Tu D, Zhang Y, Zhang P, Jia H, Huang X, Cai Y, Yin S, Jiang R, Tian W, Gao W, Liu J, Yang H, Cheng X, Zang R. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):439-449. doi: 10.1016/S1470-2045(21)00006-1. Epub 2021 Mar 8.

    PubMed 33705695

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Secondary Cytoreductive Surgery and Salvage Chemotherapy in people with Ovarian Epithelial Cancer Recurrent and Fallopian Tube Carcinoma, run by Shanghai Gynecologic Oncology Group at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Up to 60 months after last patient randomized). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01611766, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.

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