Squamous Cell Carcinoma of CervixPhase 2SideNCT02879214
Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer
A Phase 2 study testing Simultaneous boost along with chemo in people with Squamous Cell Carcinoma of Cervix, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Squamous Cell Carcinoma of Cervix
- What is being tested?
- Simultaneous boost along with chemo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Feb 2020
- Phase
- Phase 2
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed squamous cell carcinoma of cervix, able to receive chemotherapy and concurrent chemoradiotherapy.
- Good performance status. Negative pregnancy test in women of child-bearing potential. Signed study-specific informed consent. Lab results within study specific limits
Who cannot join
- Prior radiation to the abdomen or pelvis. A history of Scleroderma or Inflammatory bowel disease. Contraindication to chemotherapy or radiation
Trial locations and contacts
1 site in 1 country.
Haixia Pan, MD contact
China1 site, 1 recruiting
- Recruiting
Sichuan PPH, Departmentn of Gynecology Oncology
Chengdu, Sichuan, 610072
Lan Xie, MD, 086-87398097
Yi Liu, MD, 086-87398097
About this study
Official title: Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer (SIDE, Advanced Squamous Cervical Cancer Trial)
The purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.
Read the detailed description
Concurrent radiation therapy and chemotherapy is the standard of care for locally advanced cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into minimal invasive surgical resection after maximal downstage. This protocol is designed to determine the dose escalation of both chemo and radiation for treating tumor bearing regions within the abdomen and pelvis, using an two drug chemotherapy in first cycle of mitomycin/cisplatin or taxol/cisplatin along with simultaneously integrated boost technique to Biological target area defined by PET scan. This dose escalation is to downstage disease for minimal invasive surgical resection.
- Conditions
- Squamous Cell Carcinoma of Cervix
- Being tested
- Simultaneous boost along with chemo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous boost along with chemoRadiation
Prior studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3), the studies often use single drug. This study treatment plan will use dose intensify in both chemotherapy and radiation. The chemotherapy have two drugs regimens of mitomycin with cisplatin or taxol with cisplatin along of radiation dose escalate, the RT dose escalation to biological GTV defined by PET scan to dose of 57.50 Gy in 25 fx while the elective volumes are held constant at 45 Gy.
| Study group | Role | What they receive |
|---|---|---|
| SIDE cervical trial | Experimental | To Maximal downstage locally advanced squamous cell cervical cancer before minimal invasive surgical resection. The SIDE study is to use both RT dose escalation to the biological target defined by PET and Chemo dose escalation composited with two drugs to achieve maximal reduction of tumor burden, providing feasibility of minimal invasive surgical resection. Receives: Radiation: Simultaneous boost along with chemo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To observe the efficacy from radiation therapy dose escalation
40 participants will be evaluated with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 4 year
Secondary outcomes (2)
To evaluate the chemoradiation in Stage IIB~ III carcinoma cervix
40 Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, to see any adverse events within 12 months
Measured: 4 years
Disease free survival(DFS)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ming zeng, MD, Sichuan Provincial People's Hospital
- Investigators
- Ming Zeng, MD PhD, Study chair, Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879214
- Sponsor's protocol ID
- 201604
- Acronym
- Side
- Status last verified
- Apr 2018
- First submitted
- 10 Aug 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer (SIDE, Advanced Squamous Cervical Cancer Trial)
- ClinicalTrials.gov ID
- NCT02879214
- Acronym / sponsor ID
- Side / 201604
- Conditions
- Squamous Cell Carcinoma of Cervix
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.
Detailed description
Concurrent radiation therapy and chemotherapy is the standard of care for locally advanced cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into minimal invasive surgical resection after maximal downstage. This protocol is designed to determine the dose escalation of both chemo and radiation for treating tumor bearing regions within the abdomen and pelvis, using an two drug chemotherapy in first cycle of mitomycin/cisplatin or taxol/cisplatin along with simultaneously integrated boost technique to Biological target area defined by PET scan. This dose escalation is to downstage disease for minimal invasive surgical resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIDE cervical trial | Experimental | Radiation: Simultaneous boost along with chemoTo Maximal downstage locally advanced squamous cell cervical cancer before minimal invasive surgical resection. The SIDE study is to use both RT dose escalation to the biological target defined by PET and Chemo dose escalation composited with two drugs to achieve maximal reduction of tumor burden, providing feasibility of minimal invasive surgical resection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Biopsy confirmed squamous cell carcinoma of cervix, able to receive chemotherapy and concurrent chemoradiotherapy.
- Good performance status. Negative pregnancy test in women of child-bearing potential. Signed study-specific informed consent. Lab results within study specific limits
Key exclusion criteria (1 listed)
- Prior radiation to the abdomen or pelvis. A history of Scleroderma or Inflammatory bowel disease. Contraindication to chemotherapy or radiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous boost along with chemoPrior studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3), the studies often use single drug. This study treatment plan will use dose intensify in both chemotherapy and radiation. The chemotherapy have two drugs regimens of mitomycin with cisplatin or taxol with cisplatin along of radiation dose escalate, the RT dose escalation to biological GTV defined by PET scan to dose of 57.50 Gy in 25 fx while the elective volumes are held constant at 45 Gy. | Radiation | SIDE cervical trial |
Primary outcome
To observe the efficacy from radiation therapy dose escalation
Time frame: 4 year
40 participants will be evaluated with treatment-related adverse events as assessed by CTCAE v4.0
2 secondary outcomes
To evaluate the chemoradiation in Stage IIB~ III carcinoma cervix
Time frame: 4 years
Disease free survival(DFS)
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haixia Pan, MD contact
Ming Zeng, MD PhD study chair
Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Simultaneous boost along with chemo in people with Squamous Cell Carcinoma of Cervix, run by Sichuan Provincial People's Hospital at 1 site 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 2 inclusion and 1 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Ming Zeng, MD PhD (086-17708131336, miller2002@yahoo.acom), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To observe the efficacy from radiation therapy dose escalation (time frame: 4 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2018.