Locally Advanced Cervical CarcinomaPhase 1/2HYACINCTNCT05210270
HYpofractionated Pelvic Radiotherapy for Advanced Cervical Cancers INeligible for ChemoTherapy
A Phase 1/2 study testing Hypofractionation in people with Locally Advanced Cervical Carcinoma, run by University of Santo Tomas Hospital, Philippines.
Trial summary
BACKGROUND: For patients with locally advanced cervical cancer (LACC) ineligible for concurrent chemotherapy, radiotherapy (RT) alone achieves complete response rate (CRR) <70% and long-term locoregional control (LRC) <62%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Carcinoma
- What is being tested?
- Hypofractionation
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Mar 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged ≥18 years
- Histologically confirmed cervical squamous, adeno-, or adenosquamous carcinoma
- 2018 Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage IIIA-IIIC1, IVA
- Pelvic nodal metastases (for the phase 1 cohorts)
- Contraindication to chemotherapy
- Brachytherapy candidate
Show all 9Show fewer
- World Health Organization (WHO)/ECOG performance status of ≤2
- Life expectancy of at least 12 weeks
- Adequate bone marrow function: Absolute neutrophil count ≥1,500 cell/mm3; Platelets ≥100,000 cell/mm3; Hemoglobin ≥10.0 g/dL; Leukocyte count ≥4,000 cell/mm3
Who cannot join
- Other histology (small cell, neuroendocrine, lymphoma, sarcoma, etc.)
- 2018 FIGO Stage IIIC2 (para-aortic nodal metastases)
- Clinical and/or radiologic evidence of metastatic disease
- History of another malignancy except for the following: malignancy treated with curative intent and with no known active disease ≥5 years and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma-in-situ without evidence of disease
- Pregnancy
- Uncontrolled concurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic GI conditions associated with diarrhea (including Crohn's disease or ulcerative colitis), or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events or compromise the ability of the patient to give written informed consent
Show all 11Show fewer
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
- Prior hysterectomy
- Prior treatment for cervical cancer
- Prior pelvic radiotherapy
- Concomitant anti-cancer therapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Teresa Sy Ortin, MD contact
About this study
Official title: Phase 1/2 Trial Evaluating the Effectiveness and Safety of Dose-adapted HYpofractionated Pelvic Radiotherapy for Advanced Cervical Cancers INeligible for ChemoTherapy
BACKGROUND: For patients with locally advanced cervical cancer (LACC) ineligible for concurrent chemotherapy, radiotherapy (RT) alone achieves complete response rate (CRR) <70% and long-term locoregional control (LRC) <62%. Hypofractionated (HF-)RT using older techniques results in comparable CRR and disease control, and low late toxicity rates (4-8%). Dose-adapted HF-RT using intensity-modulated radiotherapy (IMRT) with nodal simultaneous integrated boost (nSIB) could improve tumor control and toxicity.
GENERAL OBJECTIVE: To determine the effectiveness and safety of HF-RT with (or without) nSIB in LACC among patients who are chemo-ineligible.
Read more
PRIMARY OBJECTIVES:
Phase 1: To determine the maximum tolerated dose (MTD) for nSIB used in combination with pelvic HF-RT (2.67 Gray (Gy) x 15 fractions), using IMRT Phase 2: To assess the efficacy of HF-RT ± nSIB in terms of complete response rates at 3 months
SECONDARY OBJECTIVES:
To assess the efficacy of HF-RT ± nSIB in terms of progression free survival (PFS), locoregional PFS, distant metastasis free survival (DMFS), cervical cancer specific survival (CCSS), overall survival (OS)
To assess the acute and late toxicity of HF-RT ± nSIB, and patient-reported quality of life outcomes
EXPLORATORY OBJECTIVES:
To evaluate the predictive utility of clinical and dosimetric variables for tumor response/control and toxicity. Variables: age, performance status, T- and N-stage, T-score, histology, baseline hemoglobin, clinical target volume and organs-at-risk doses, overall treatment time
STUDY DESIGN:
Phase 1: Dose-escalation study (standard 3+3 design) Phase 2: Single-arm clinical trial (Simon's two-stage design)
STUDY TREATMENTS:
Pelvic HF-RT ± nSIB to 40 Gy in 15 fractions using IMRT, followed by brachytherapy (BRT) 6.5-7.5 Gy x 4 fractions using 2D or image-guided techniques
SAMPLE SIZE:
One-sided hypothesis testing. H0: CRR p0 ≤64%; H1: CRR p1 ≥84%. Simon 2 stage: First stage, n1=28 will be enrolled. If response (r1) ≤18, the study will be stopped for futility. Otherwise, second stage: n2=22, for a total of 50.
H0 will be rejected if r1+r2 ≥38, in 50 patients. This yields a type I error rate of 5% and power of 95% when the true response rate is ≥84%.
Accrual: Accounting for 10% attrition, a n=55 will be targeted. At a rate of 4-5 patients quarterly, accrual may take 33-42 months. The trial may be opened to other centers to accelerate accrual.
Read the detailed description
SAMPLE SIZE CALCULATION:
CRR with chemoradiotherapy based on a meta-analysis in 2017 is about 80%; with advanced RT techniques, based on a multi-center, prospective study, local control rate >90% could be achieved.
Based on retrospective studies, CRR with HF-RT without concurrent chemotherapy (ChT) followed by BRT, using 2D techniques, is about 70%. This is comparable to CRR for conventionally fractionated RT without concurrent ChT in the above meta-analysis. Given the retrospective nature of HF-RT data, a low CRR of 64% could be projected (p0). Given that in the current study, the investigators propose to do dose-adapted radiation by using more advanced RT and BRT, a high CRR of 84% could be projected (p1).
In the first stage, 28 patients will be accrued, including the 3 or 6 patients enrolled in the MTD level from phase 1. If there are ≤18 responses in these 28 patients, the study will be stopped. Otherwise, 22 additional patients will be accrued in the second stage, for a total of 50.
The null hypothesis will be rejected if >38 responses are observed in 50 patients. This design yields a type I error rate of 5% and power of 95% when the true response rate is ≥84%.
Accounting for 10% attrition, a sample size of 55 will be targeted.
INDICATION:
Patients must meet all the inclusion criteria and none of the exclusion criteria to be eligible for this trial. Contraindication to ChT may be due to a medical contraindication or patient refusal to receive chemotherapy, and will be documented by the referring/attending gynecologic oncologist in the referral letter.
To effectively manage any conflict of interest, the attending/referring gynecologic oncologist shall not participate in the recruitment process. Any eligible patient will be referred to the Radiation Oncology Department, where the recruitment process will be initiated by the Primary Investigator or a delegated radiation oncology consultant.
TREATMENT REGIMEN:
The regimen consists of whole pelvic photon RT, using IMRT, followed by high dose rate (HDR) BRT. Inguinal fields shall be included in case of lower vaginal or inguinal nodal involvement. The prescription dose is 40 Gy in 15 fractions at 2.67 Gy/fraction.
The nSIB in the phase 2 will be given according to the MTD level in phase 1. The nSIB is indicated for any adenopathy detected by either positron emission tomography (PET)-positivity, by computed tomography (CT)/ magnetic resonance imaging (MRI) criteria such as a short axis diameter >10mm (15mm, for inguinal nodes), or histologically positive on surgical sampling. The gross nodal planning target volume (PTV) boost will receive 45-48 Gy in 3.0-3.2 Gy/fraction, depending on the projected contribution of BRT and location of the lymph node. Assuming both nodal boost dose levels are found to be associated with acceptable toxicity: common iliac or inguinal nodes will be boosted to 48 Gy; and external or internal iliac nodes, to 45 Gy given the BRT contribution to the total nodal dose.
The RT will be given once daily from Monday to Friday, 5 fractions per week.
BRT will be given after completion of pelvic RT, ideally within two weeks from completion. Two insertions per week may be done. If multiple fractions will be given using the same implant, these will be given twice daily, 6 hours apart.
- Conditions
- Locally Advanced Cervical Carcinoma
- Being tested
- Hypofractionation
- Keywords
- Hypofractionation, Nodal simultaneous integrated boost, Intensity-modulated radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypofractionationRadiation
Also called Nodal simultaneous integrated boost, Brachytherapy
Phase 1 (Dose Escalation Study):
Pelvic hypofractionated radiotherapy (40 Gy over 15 daily fractions) with nSIB 45 Gy (first dose level) and 48 Gy (second dose level); to be followed by brachytherapy (6.5-7.5 Gy x 4 fractions)
Phase 2 (Efficacy Study):
Pelvic hypofractionated radiotherapy (40 Gy over 15 daily fractions) with (or without) nSIB 45-48 Gy (depending on phase 1 results); to be followed by brachytherapy (6.5-7.5 Gy x 4 fractions)
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (for phase 1)
The highest dose studied for which the incidence of dose-limiting toxicity was less than 33%
Measured: 4 months
Complete response rate (for phase 2)
Proportion of treated patients with disappearance of all lesions on clinical and radiologic examination
Measured: 3 months
Secondary outcomes (12)
Progression-free survival
Time from date of enrolment to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first
Measured: 5 years
Locoregional progression-free survival
Time from date of enrolment to date of locoregional progression, date of death from any cause, or date of last follow-up, whichever occurs first
Measured: 5 years
Metastasis-free survival
Time from date of enrolment to date of development of metastasis, date of death from any cause, or date of last follow-up, whichever occurs first
Measured: 5 years
Cervical cancer-specific survival
Time from date of enrolment to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first
Measured: 5 years
Overall survival
Time from date of enrolment to date of death from any cause, or date of last follow-up, whichever occurs first
Measured: 5 years
Acute and subacute toxicity
Radiation toxicity per RTOG criteria documented during and within 3-4 months from completion of treatment
Measured: 4 months
Late toxicity
Radiation toxicity per RTOG criteria documented beyond 4 months from completion of treatment
Measured: 5 years
Expanded Prostate Index Composite - Urinary Domain Scores
Multi-item questionnaire on urinary function, with scores transformed linearly from 0-100, with higher scores representing better quality of life.
Measured: 5 years
Expanded Prostate Index Composite - Bowel Domain Scores
Multi-item questionnaire on bowel function, with scores transformed linearly from 0-100, with higher scores representing better quality of life.
Measured: 5 years
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 Scores
Multi-item questionnaire on functions, symptoms and global quality of life, with scores transformed linearly from 0-100, with higher scores representing better quality of life.
Measured: 5 years
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cervix 24 Scores
Multi-item questionnaire on cervical cancer specific aspects of quality of life, with scores transformed linearly from 0-100, with higher scores representing better quality of life.
Measured: 5 years
Patient's Global Impression of Change (PGIC)
Reflects a patient's belief about the efficacy of treatment, from 1-7, with higher scores representing better patient's rating of overall improvement.
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 posted27 Jan 2022
- Study startJan 2024 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2030 (estimated)
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 Locally Advanced Cervical CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two-phase study Phase 1: Dose-escalation study using standard 3+3 design Phase 2: Single-arm clinical trial using Simon's two-stage design
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Santo Tomas Hospital, Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Philippine Council for Health Research & Development
- Responsible party
- Principal investigator, Warren Bacorro, University of Santo Tomas Hospital, Philippines
- Investigators
- Warren Bacorro, MD, Principal investigator, University of Santo Tomas Hospital, Philippines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210270
- Sponsor's protocol ID
- USTH-BCI-RO-2022-01
- Other IDs
- REC-2021-08-104-CT
- Acronym
- HYACINCT
- Status last verified
- Jan 2023
- First submitted
- 27 Dec 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data by emailing the primary investigator. All request will be evaluated by the study team and the USTH-REC.
Publications
Bacorro W, Baldivia K, Dumago M, Bojador M, Milo A, Trinidad CM, Mariano J, Gonzalez G, Sy Ortin T. Phase 1/2 trial evaluating the effectiveness and safety of dose-adapted Hypofractionated pelvic radiotherapy for Advanced Cervical cancers INeligible for ChemoTherapy (HYACINCT). Acta Oncol. 2022 Jun;61(6):688-697. doi: 10.1080/0284186X.2022.2048070. Epub 2022 Mar 14.
PubMed 35285405
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2 Trial Evaluating the Effectiveness and Safety of Dose-adapted HYpofractionated Pelvic Radiotherapy for Advanced Cervical Cancers INeligible for ChemoTherapy
- ClinicalTrials.gov ID
- NCT05210270
- Acronym / sponsor ID
- HYACINCT / USTH-BCI-RO-2022-01
- Conditions
- Locally Advanced Cervical Carcinoma
- Keywords
- Hypofractionation, Nodal simultaneous integrated boost, Intensity-modulated radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University of Santo Tomas Hospital, PhilippinesUniversity, hospital or other
- Collaborators
- Philippine Council for Health Research & Development
- Study start
- Jan 2024 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 27 Jan 2022 (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.
BACKGROUND: For patients with locally advanced cervical cancer (LACC) ineligible for concurrent chemotherapy, radiotherapy (RT) alone achieves complete response rate (CRR) <70% and long-term locoregional control (LRC) <62%. Hypofractionated (HF-)RT using older techniques results in comparable CRR and disease control, and low late toxicity rates (4-8%). Dose-adapted HF-RT using intensity-modulated radiotherapy (IMRT) with nodal simultaneous integrated boost (nSIB) could improve tumor control and toxicity.
GENERAL OBJECTIVE: To determine the effectiveness and safety of HF-RT with (or without) nSIB in LACC among patients who are chemo-ineligible.
PRIMARY OBJECTIVES:
Phase 1: To determine the maximum tolerated dose (MTD) for nSIB used in combination with pelvic HF-RT (2.67 Gray (Gy) x 15 fractions), using IMRT Phase 2: To assess the efficacy of HF-RT ± nSIB in terms of complete response rates at 3 months
SECONDARY OBJECTIVES:
To assess the efficacy of HF-RT ± nSIB in terms of progression free survival (PFS), locoregional PFS, distant metastasis free survival (DMFS), cervical cancer specific survival (CCSS), overall survival (OS)
To assess the acute and late toxicity of HF-RT ± nSIB, and patient-reported quality of life outcomes
EXPLORATORY OBJECTIVES:
To evaluate the predictive utility of clinical and dosimetric variables for tumor response/control and toxicity. Variables: age, performance status, T- and N-stage, T-score, histology, baseline hemoglobin, clinical target volume and organs-at-risk doses, overall treatment time
STUDY DESIGN:
Phase 1: Dose-escalation study (standard 3+3 design) Phase 2: Single-arm clinical trial (Simon's two-stage design)
STUDY TREATMENTS:
Pelvic HF-RT ± nSIB to 40 Gy in 15 fractions using IMRT, followed by brachytherapy (BRT) 6.5-7.5 Gy x 4 fractions using 2D or image-guided techniques
SAMPLE SIZE:
One-sided hypothesis testing. H0: CRR p0 ≤64%; H1: CRR p1 ≥84%. Simon 2 stage: First stage, n1=28 will be enrolled. If response (r1) ≤18, the study will be stopped for futility. Otherwise, second stage: n2=22, for a total of 50.
H0 will be rejected if r1+r2 ≥38, in 50 patients. This yields a type I error rate of 5% and power of 95% when the true response rate is ≥84%.
Accrual: Accounting for 10% attrition, a n=55 will be targeted. At a rate of 4-5 patients quarterly, accrual may take 33-42 months. The trial may be opened to other centers to accelerate accrual.
Detailed description
SAMPLE SIZE CALCULATION:
CRR with chemoradiotherapy based on a meta-analysis in 2017 is about 80%; with advanced RT techniques, based on a multi-center, prospective study, local control rate >90% could be achieved.
Based on retrospective studies, CRR with HF-RT without concurrent chemotherapy (ChT) followed by BRT, using 2D techniques, is about 70%. This is comparable to CRR for conventionally fractionated RT without concurrent ChT in the above meta-analysis. Given the retrospective nature of HF-RT data, a low CRR of 64% could be projected (p0). Given that in the current study, the investigators propose to do dose-adapted radiation by using more advanced RT and BRT, a high CRR of 84% could be projected (p1).
In the first stage, 28 patients will be accrued, including the 3 or 6 patients enrolled in the MTD level from phase 1. If there are ≤18 responses in these 28 patients, the study will be stopped. Otherwise, 22 additional patients will be accrued in the second stage, for a total of 50.
The null hypothesis will be rejected if >38 responses are observed in 50 patients. This design yields a type I error rate of 5% and power of 95% when the true response rate is ≥84%.
Accounting for 10% attrition, a sample size of 55 will be targeted.
INDICATION:
Patients must meet all the inclusion criteria and none of the exclusion criteria to be eligible for this trial. Contraindication to ChT may be due to a medical contraindication or patient refusal to receive chemotherapy, and will be documented by the referring/attending gynecologic oncologist in the referral letter.
To effectively manage any conflict of interest, the attending/referring gynecologic oncologist shall not participate in the recruitment process. Any eligible patient will be referred to the Radiation Oncology Department, where the recruitment process will be initiated by the Primary Investigator or a delegated radiation oncology consultant.
TREATMENT REGIMEN:
The regimen consists of whole pelvic photon RT, using IMRT, followed by high dose rate (HDR) BRT. Inguinal fields shall be included in case of lower vaginal or inguinal nodal involvement. The prescription dose is 40 Gy in 15 fractions at 2.67 Gy/fraction.
The nSIB in the phase 2 will be given according to the MTD level in phase 1. The nSIB is indicated for any adenopathy detected by either positron emission tomography (PET)-positivity, by computed tomography (CT)/ magnetic resonance imaging (MRI) criteria such as a short axis diameter >10mm (15mm, for inguinal nodes), or histologically positive on surgical sampling. The gross nodal planning target volume (PTV) boost will receive 45-48 Gy in 3.0-3.2 Gy/fraction, depending on the projected contribution of BRT and location of the lymph node. Assuming both nodal boost dose levels are found to be associated with acceptable toxicity: common iliac or inguinal nodes will be boosted to 48 Gy; and external or internal iliac nodes, to 45 Gy given the BRT contribution to the total nodal dose.
The RT will be given once daily from Monday to Friday, 5 fractions per week.
BRT will be given after completion of pelvic RT, ideally within two weeks from completion. Two insertions per week may be done. If multiple fractions will be given using the same implant, these will be given twice daily, 6 hours apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Two-phase study Phase 1: Dose-escalation study using standard 3+3 design Phase 2: Single-arm clinical trial using Simon's two-stage design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females aged ≥18 years
- Histologically confirmed cervical squamous, adeno-, or adenosquamous carcinoma
- 2018 Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage IIIA-IIIC1, IVA
- Pelvic nodal metastases (for the phase 1 cohorts)
- Contraindication to chemotherapy
Key exclusion criteria (11 listed)
- Other histology (small cell, neuroendocrine, lymphoma, sarcoma, etc.)
- 2018 FIGO Stage IIIC2 (para-aortic nodal metastases)
- Clinical and/or radiologic evidence of metastatic disease
- History of another malignancy except for the following: malignancy treated with curative intent and with no known active disease ≥5 years and of low potential risk for recurrence; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma-in-situ without evidence of disease
- Pregnancy
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 |
|---|---|---|
| HypofractionationAlso: Nodal simultaneous integrated boost, BrachytherapyPhase 1 (Dose Escalation Study): Pelvic hypofractionated radiotherapy (40 Gy over 15 daily fractions) with nSIB 45 Gy (first dose level) and 48 Gy (second dose level); to be followed by brachytherapy (6.5-7.5 Gy x 4 fractions) Phase 2 (Efficacy Study): Pelvic hypofractionated radiotherapy (40 Gy over 15 daily fractions) with (or without) nSIB 45-48 Gy (depending on phase 1 results); to be followed by brachytherapy (6.5-7.5 Gy x 4 fractions) | Radiation | – |
Primary outcome
Maximum tolerated dose (for phase 1)
Time frame: 4 months
The highest dose studied for which the incidence of dose-limiting toxicity was less than 33%
Complete response rate (for phase 2)
Time frame: 3 months
Proportion of treated patients with disappearance of all lesions on clinical and radiologic examination
12 secondary outcomes
Progression-free survival
Time frame: 5 years
Locoregional progression-free survival
Time frame: 5 years
Metastasis-free survival
Time frame: 5 years
Cervical cancer-specific survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Acute and subacute toxicity
Time frame: 4 months
Late toxicity
Time frame: 5 years
Expanded Prostate Index Composite - Urinary Domain Scores
Time frame: 5 years
Expanded Prostate Index Composite - Bowel Domain Scores
Time frame: 5 years
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 Scores
Time frame: 5 years
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Cervix 24 Scores
Time frame: 5 years
Patient's Global Impression of Change (PGIC)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 35285405Bacorro W, Baldivia K, Dumago M, Bojador M, Milo A, Trinidad CM, Mariano J, Gonzalez G, Sy Ortin T. Phase 1/2 trial evaluating the effectiveness and safety of dose-adapted Hypofractionated pelvic radiotherapy for Advanced Cervical cancers INeligible for ChemoTherapy (HYACINCT). Acta Oncol. 2022 Jun;61(6):688-697. doi: 10.1080/0284186X.2022.2048070. Epub 2022 Mar 14.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data by emailing the primary investigator. All request will be evaluated by the study team and the USTH-REC.
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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.
Teresa Sy Ortin, MD contact
Warren Bacorro, MD principal investigator
University of Santo Tomas Hospital, Philippines
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hypofractionation in people with Locally Advanced Cervical Carcinoma, run by University of Santo Tomas Hospital, Philippines.
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 11 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: opening soon, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warren Bacorro, MD (+639171665927, wrbacorro@ust.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (for phase 1) (time frame: 4 months). 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 NCT05210270, 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 31 Jan 2023.