Cervix CancerNCT03239613
Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer
A study testing POHIM-CCRT in people with Cervix Cancer and Radiotherapy, Adjuvant, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated
- What is being tested?
- POHIM-CCRT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Aug 2017to 28 Apr 2023
- Phase
- Interventional
- 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 20 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histologically confirmed cervical cancer
- radical hysterectomy and pelvic lymph node dissection was done
- histologically indicated adjuvant chemoradiotherapy (more than one as below)
- positive pelvic lymph node metastasis
- positive parametrial invasion
- positive tumor involvement on surgical margin
Show all 9Show fewer
- ECOG performance status 0 or 1
- Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl
- Kidney function: Creatinine <2.0 mg/dL, Bilirubin 1.5 mg/dl
Who cannot join
- positive distant metastasis (including retroperitoneal lymph node metastasis)
- previous history of pelvic radiotherapy
- more than 3 months after radical surgery for cervical cancer
- neoadjuvant chemotherapy was done
- previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_CCRT Trial)
To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.
- Conditions
- Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Hypofractionated Dose, Chemotherapy, Concurrent
- Being tested
- POHIM-CCRT
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POHIM-CCRTOther
postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
| Study group | Role | What they receive |
|---|---|---|
| POHIM-CCRT | Other | postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day) Receives: Other: POHIM-CCRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicities according to CTCAE v4.0
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
Measured: 3 months
Secondary outcomes (2)
Late toxicities according to CTCAE v4.0
evaluation of late toxicities every year after 3months after radiotherapy according to CTCAE v4.0
Measured: 5-years
Progression free survival rate
progression free survival rate after the time of surgery
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start31 Aug 2017
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervix CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239613
- Sponsor's protocol ID
- SMC 2017-03-091-003
- Status last verified
- Nov 2023
- First submitted
- 2 Aug 2017
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho WK, Park W, Kim SW, Lee KK, Ahn KJ, Choi JH. Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer: The POHIM-CCRT Nonrandomized Controlled Trial. JAMA Oncol. 2024 Jun 1;10(6):737-743. doi: 10.1001/jamaoncol.2024.0565.
PubMed 38662364
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Hypofractionated Intensity-modulated Radiation Therapy with Concurrent Chemotherapy in Cervical Cancer: a Prospective Exploratory Trial (POHIM_CCRT Trial)
- ClinicalTrials.gov ID
- NCT03239613
- Acronym / sponsor ID
- SMC 2017-03-091-003
- Conditions
- Cervix Cancer, Radiotherapy, Adjuvant, Radiotherapy, Intensity-Modulated, Hypofractionated Dose, Chemotherapy, Concurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 4 Aug 2017 (actual)
- 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.
To investigate the acute toxicities, late toxicities, and treatment results when the early cervical cancer patients are treated by concurrent chemotherapy with hypofractionated intensity-modulated radiotherapy (2.5 Gy X 16 fractions, once a day) after radical hysterectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POHIM-CCRT | Other | Other: POHIM-CCRTpostoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically confirmed cervical cancer
- radical hysterectomy and pelvic lymph node dissection was done
- histologically indicated adjuvant chemoradiotherapy (more than one as below)
- ECOG performance status 0 or 1
- Bone marrow function: granulocyte ≥1.0 x 1000/µl, platelet ≥30 x 1000/µl, hemoglobin ≥10 g/dl
Key exclusion criteria (5 listed)
- positive distant metastasis (including retroperitoneal lymph node metastasis)
- previous history of pelvic radiotherapy
- more than 3 months after radical surgery for cervical cancer
- neoadjuvant chemotherapy was done
- previous history of other carcinoma except for thyroid cancer, skin cancer, in situ carcinoma on cervix
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 |
|---|---|---|
| POHIM-CCRTpostoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day) | Other | POHIM-CCRT |
Primary outcome
Acute toxicities according to CTCAE v4.0
Time frame: 3 months
evaluation of acute toxicities within 3months after radiotherapy according to CTCAE v4.0
2 secondary outcomes
Late toxicities according to CTCAE v4.0
Time frame: 5-years
Progression free survival rate
Time frame: 5-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Derived from this study: PubMed 38662364Cho WK, Park W, Kim SW, Lee KK, Ahn KJ, Choi JH. Postoperative Hypofractionated Intensity-Modulated Radiotherapy With Concurrent Chemotherapy in Cervical Cancer: The POHIM-CCRT Nonrandomized Controlled Trial. JAMA Oncol. 2024 Jun 1;10(6):737-743. doi: 10.1001/jamaoncol.2024.0565.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POHIM-CCRT in people with Cervix Cancer and Radiotherapy, Adjuvant, run by Samsung Medical Center at 1 site in South Korea.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 3 Jan 2025. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute toxicities according to CTCAE v4.0 (time frame: 3 months). 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 NCT03239613, which also lists 1 linked publication.
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 3 Jan 2025.