Ovarian CancerPhase 1NCT02545010
Phase I Low Dose WART in Combination With Weekly Paclitaxel for Platinum Resistant Ovarian Cancer
A Phase 1 study testing Paclitaxel and LDWART (Low Dose Whole Abdominal Radiation Therapy) in people with Ovarian Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic malignancies and is the fifth leading cause of cancer death in women in the United States.1 Despite initial high response rates, 50% to 75% of women who present with advanced disease suffer relapse and require re treatment2.The optimal… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Paclitaxel and LDWART (Low Dose Whole Abdominal Radiation Therapy)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2015to Aug 2018
- Phase
- Phase 1
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
- Age ≥ 21 years.
- Histologically confirmed and documented epithelial ovarian carcinomas, primary peritoneal carcinomas, or fallopian tube carcinomas.
- Patients must have platinum-resistant disease, (defined as progression within <6 months from completion of a minimum of 4 platinum therapy cycles. The date should be calculated from the last administered dose of platinum therapy).
- Patients must have evidence of measurable intra abdominal disease at point of screening.
- Patients must have disease that is measurable according to RECIST version 1.1 and assessable according to the GCIG CA-125 criteria and require treatment with chemotherapy within 14 days of screening. Target lesions should not be selected in previously irradiated fields unless there is clear evidence of progression
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- Performance status of Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
- Life expectancy of ≥12 weeks with standard treatment.
- Has adequate organ function at Baseline, including the following (noting that repeated tests at baseline should not be performed unless there are sufficient reasons to assume the patient would meet the inclusion criteria with re-testing):
- Absolute neutrophil count ≥1.0 × 109/L
- Platelet count ≥100 × 109/L (without transfusions within 21 days prior to Day 1 of Cycle 1)
- Hemoglobin ≥9 g/dL
- Prothrombin time and partial thromboplastin time within ≤1.5 × upper limit of normal (ULN)
- International normalized ratio ≤1.5 × ULN
- Total bilirubin ≤1.5 × ULN
- Transaminases (aspartate aminotransferase and/or alanine aminotransferase ≤2.5 × ULN (<5 × ULN if liver metastases)
- Has a negative serum pregnancy test 14 days prior to starting study drug plus a negative urine pregnancy test on Day 1, Cycle 1 prior to treatment (applies to females of childbearing potential only).
Who cannot join
- General Criteria
- Is a female patient of childbearing potential, defined as a female physiologically capable of becoming pregnant (including a female whose career, lifestyle, or sexual orientation precludes intercourse with a male partner, and females whose partners have been sterilized by vasectomy or other means), unless they are using a highly effective method for birth control throughout the study and for 12 weeks after the end of treatment. Highly effective methods for birth control include the following:
- Total abstinence: This is an acceptable method when this is consistent with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization: The patient has had a surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to taking study drug. In case of an oophorectomy alone, the reproductive status of the patient must have been confirmed by follow-up hormone level assessment.
- Male partner sterilization: The patient has the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate.
- (For female patients on the study, the vasectomized male partner should be the sole partner for that patient.)
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- These patients must also agree to the following:
- Use of a combination of the following (1+2):
- Placement of an intrauterine device or intrauterine system
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam, gel, film, or cream, or vaginal suppository Reliable contraception maintained throughout the study and for 12 weeks after study drug discontinuation
- Females considered post-menopausal and not of childbearing potential: The definition applies to females who have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone levels >40 mIU/mL (for US only: and estradiol <20 pg/mL) or have had surgical bilateral oophorectomy (with or without hysterectomy) at least 6 weeks prior to starting treatment.
- In the case of oophorectomy alone, only when the reproductive status of the patient has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
- Is a pregnant or nursing (lactating) female, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin laboratory test (>5 mIU/mL). Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start).
- Is unwilling to or unable to comply with the protocol.
- Cancer-related
- Non-epithelial ovarian cancers (Germ cell and stromal ovarian neoplasms)
- Ovarian tumors with low malignant potential (i.e. borderline tumors).
- History of other clinically active malignancy within 5 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast.
- Has central nervous system metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery, and stable disease for at least 8 weeks without steroid use for at least 4 weeks prior to the first dose of weekly paclitaxel.
- Symptomatic intestinal obstruction requiring surgical intervention or bowel rest.
- Prior, current or planned treatment:
- Previous treatment with 3 or more anticancer regimens.
- Has used other investigational drugs within 4 weeks or five half-lives (whichever is longer) prior to the first dose of study treatment.
- Has received prior radiation therapy within 4 weeks, or limited field radiation within 2 weeks, prior to starting study drug, or the side effects of such therapy have not resolved to ≤Grade 1.
- Has had a major surgical procedure within 4 weeks from starting the study drug. Patient has not fully recovered from all surgery-related complications to ≤Grade 1
- Prior or concomitant conditions or procedures:
- History or evidence upon physical / neurological examination of CNS disease unrelated to cancer, unless adequately treated with standard medical therapy (e.g. uncontrolled seizures).
- Pre-existing peripheral neuropathy ≥ CTC grade.
- Serious active infection requiring intravenous antibiotics and/or hospitalization at study entry.
- Known grade 3 or ≥ hypersensitivity to any of the study drugs or excipients.
- Evidence of any other medical conditions (such as psychiatric illness, etc.), physical examination or laboratory findings that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications.
- Has a history of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.
- Has severe or unstable medical conditions such as heart failure, ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, an ongoing cardiac arrhythmia requiring medication (≥Grade 2, according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] Version 4.03), or any other significant or unstable concurrent medical illness that in the opinion of the investigator would preclude protocol therapy.
- Has a known history of human immunodeficiency virus seropositivity or other active bacterial, viral, or fungal infections. Hep B or C positive patients on anti-viral treatment are eligible for the study
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 164119
David SP Tan, 65 6779 5555, david_sp_tan@nuhs.edu.sg
About this study
Official title: Phase I Study of Low Dose Whole Abdominal Radiation Therapy (LDWART) in Combination With Weekly Paclitaxel for Platinum Resistant Ovarian Cancer With Predominant Non-visceral Abdominal Disease
Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic malignancies and is the fifth leading cause of cancer death in women in the United States.1 Despite initial high response rates, 50% to 75% of women who present with advanced disease suffer relapse and require re treatment2.The optimal treatment for platinum resistant ovarian cancer remains hotly debated. Combination chemotherapy is not favored due to its increased toxicity and lack of convincing benefit when compared to single agent chemotherapy.3,4 Recently, the addition of bevacizumab to single agent chemotherapy in the AURELIA study improved progression free survival (PFS) from 3.4 months to 6.7 months. Response rates were also improved from 11.8% versus 27.3% (p= 0 .001).9 Aim: To determine the maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART. The recommended phase II dose (RP2D) will be based on the MTD in this Phase I study. Method: This study is designed as a prospective, single arm phase I study with 3+3 with dose de-escalation and cohort expansion. All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices. Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART(Fig.1). LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.(Fig.1). Importance of proposed research: The combination of a LDWART with weekly paclitaxel may improve the efficacy of the current standard weekly paclitaxel in platinum resistant ovarian cancer patients. Potential benefits and risks: The combination may improve treatment response. Adding LDWART may increase treatment risks, but these will be monitored closely.
- Conditions
- Ovarian Cancer
- Being tested
- Paclitaxel, LDWART (Low Dose Whole Abdominal Radiation Therapy)
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices.
Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART. Post treatment assessments will be conducted starting Day 43.
Patients will then continue chemotherapy off trial protocol with weekly paclitaxel without concurrent LDWART starting Day 50 till disease progression, intolerable toxicity, patient refusal or deemed inappropriate to continue treatment by treating physician.
LDWART (Low Dose Whole Abdominal Radiation Therapy)Radiation
LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.
LDWART will not be administered if doses of weekly paclitaxel are withheld for any reason since it functions as a "chemosensitizer". LDWART will be administered together weekly paclitaxel immediately at point of recovery from toxicity and patient is deemed to be able to continue with treatment by investigator.
| Study group | Role | What they receive |
|---|---|---|
| LDWART + paclitaxel | Experimental | All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices. Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART. LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks. Receives: Drug: Paclitaxel; Radiation: LDWART (Low Dose Whole Abdominal Radiation Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART
The maximum tolerated dose (MTD) of weekly paclitaxel and LDWART is defined as the lowest dose cohort of weekly paclitaxel and LDWART where ≥ 2 out of initial 3 or ≥ 2 out of total 6 patients in any cohort develops a DLT
Measured: Up to 6 weeks from initiation of treatment
Secondary outcomes (3)
Objective response rate (ORR)
Objective Response Rate will be assessed with RECIST v1.1 and GCIG CA-125 response criteria.
Measured: From the time of their first treatment with weekly paclitaxel and LDWART till 30 days from end of last treatment
Progression Free Survival (PFS)
Progression Free Survival will be calculated from the date of initiation of therapy to the first day when the RECIST (version 1.1) criteria for progressive disease (PD) are met.
Measured: From the time of their first treatment with weekly paclitaxel and LDWART till 1 year from end of last treatmen
Dose limiting toxicity (DLT)
Dose-limiting toxicities (DLT) occurring in the first 3 weeks of treatment in the phase I dose-escalation stage will be used in dose de-escalation decisions. Safety and toxicity will be assessed in all patients using the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 to determine the MTD and RP2D.
Measured: From the time of their first treatment with weekly paclitaxel and LDWART till 30 days from end of last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2017 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David SP Tan, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545010
- Sponsor's protocol ID
- GY01/05/15
- Other IDs
- 2015/00496, 2015
- Status last verified
- Jun 2016
- First submitted
- 7 Sep 2015
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17.
PubMed 24637997Kunos CA, Sill MW, Buekers TE, Walker JL, Schilder JM, Yamada SD, Waggoner SE, Mohiuddin M, Fracasso PM. Low-dose abdominal radiation as a docetaxel chemosensitizer for recurrent epithelial ovarian cancer: a phase I study of the Gynecologic Oncology Group. Gynecol Oncol. 2011 Feb;120(2):224-8. doi: 10.1016/j.ygyno.2010.10.018.
PubMed 21075438Ngoi NYL, Heong V, Tang JI, Choo BA, Kumarakulasinghe NB, Lim D, Low M, Lim SE, Lim YW, Leong YH, Tseng M, Tong PSY, Ilancheran A, Low JJH, Ng J, Thian YL, Koh V, Tan DSP. Phase 1 Study of Low-Dose Fractionated Whole Abdominal Radiation Therapy in Combination With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer (GCGS-01). Int J Radiat Oncol Biol Phys. 2021 Mar 1;109(3):701-711. doi: 10.1016/j.ijrobp.2020.09.059. Epub 2020 Oct 9.
PubMed 33045316
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Low Dose Whole Abdominal Radiation Therapy (LDWART) in Combination With Weekly Paclitaxel for Platinum Resistant Ovarian Cancer With Predominant Non-visceral Abdominal Disease
- ClinicalTrials.gov ID
- NCT02545010
- Acronym / sponsor ID
- GY01/05/15
- Conditions
- Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 9 Sep 2015 (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.
Background: Epithelial Ovarian Cancer is the most lethal amongst the gynecologic malignancies and is the fifth leading cause of cancer death in women in the United States.1 Despite initial high response rates, 50% to 75% of women who present with advanced disease suffer relapse and require re treatment2.The optimal treatment for platinum resistant ovarian cancer remains hotly debated. Combination chemotherapy is not favored due to its increased toxicity and lack of convincing benefit when compared to single agent chemotherapy.3,4 Recently, the addition of bevacizumab to single agent chemotherapy in the AURELIA study improved progression free survival (PFS) from 3.4 months to 6.7 months. Response rates were also improved from 11.8% versus 27.3% (p= 0 .001).9 Aim: To determine the maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART. The recommended phase II dose (RP2D) will be based on the MTD in this Phase I study. Method: This study is designed as a prospective, single arm phase I study with 3+3 with dose de-escalation and cohort expansion. All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices. Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART(Fig.1). LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.(Fig.1). Importance of proposed research: The combination of a LDWART with weekly paclitaxel may improve the efficacy of the current standard weekly paclitaxel in platinum resistant ovarian cancer patients. Potential benefits and risks: The combination may improve treatment response. Adding LDWART may increase treatment risks, but these will be monitored closely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDWART + paclitaxel | Experimental | Drug: Paclitaxel, Radiation: LDWART (Low Dose Whole Abdominal Radiation Therapy)All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices. Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART. LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements.
- Age ≥ 21 years.
- Histologically confirmed and documented epithelial ovarian carcinomas, primary peritoneal carcinomas, or fallopian tube carcinomas.
- Patients must have platinum-resistant disease, (defined as progression within <6 months from completion of a minimum of 4 platinum therapy cycles. The date should be calculated from the last administered dose of platinum therapy).
- Patients must have evidence of measurable intra abdominal disease at point of screening.
Key exclusion criteria (34 listed)
- General Criteria
- (For female patients on the study, the vasectomized male partner should be the sole partner for that patient.)
- In the case of oophorectomy alone, only when the reproductive status of the patient has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential.
- Cancer-related
- Prior, current or planned treatment:
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 |
|---|---|---|
| PaclitaxelAll patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices. Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART. Post treatment assessments will be conducted starting Day 43. Patients will then continue chemotherapy off trial protocol with weekly paclitaxel without concurrent LDWART starting Day 50 till disease progression, intolerable toxicity, patient refusal or deemed inappropriate to continue treatment by treating physician. | Drug | LDWART + paclitaxel |
| LDWART (Low Dose Whole Abdominal Radiation Therapy)LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks. LDWART will not be administered if doses of weekly paclitaxel are withheld for any reason since it functions as a "chemosensitizer". LDWART will be administered together weekly paclitaxel immediately at point of recovery from toxicity and patient is deemed to be able to continue with treatment by investigator. | Radiation | LDWART + paclitaxel |
Primary outcome
Maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART
Time frame: Up to 6 weeks from initiation of treatment
The maximum tolerated dose (MTD) of weekly paclitaxel and LDWART is defined as the lowest dose cohort of weekly paclitaxel and LDWART where ≥ 2 out of initial 3 or ≥ 2 out of total 6 patients in any cohort develops a DLT
3 secondary outcomes
Objective response rate (ORR)
Time frame: From the time of their first treatment with weekly paclitaxel and LDWART till 30 days from end of last treatment
Progression Free Survival (PFS)
Time frame: From the time of their first treatment with weekly paclitaxel and LDWART till 1 year from end of last treatmen
Dose limiting toxicity (DLT)
Time frame: From the time of their first treatment with weekly paclitaxel and LDWART till 30 days from end of last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 24637997Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial. J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17.
- Background: PubMed 21075438Kunos CA, Sill MW, Buekers TE, Walker JL, Schilder JM, Yamada SD, Waggoner SE, Mohiuddin M, Fracasso PM. Low-dose abdominal radiation as a docetaxel chemosensitizer for recurrent epithelial ovarian cancer: a phase I study of the Gynecologic Oncology Group. Gynecol Oncol. 2011 Feb;120(2):224-8. doi: 10.1016/j.ygyno.2010.10.018.
- Derived from this study: PubMed 33045316Ngoi NYL, Heong V, Tang JI, Choo BA, Kumarakulasinghe NB, Lim D, Low M, Lim SE, Lim YW, Leong YH, Tseng M, Tong PSY, Ilancheran A, Low JJH, Ng J, Thian YL, Koh V, Tan DSP. Phase 1 Study of Low-Dose Fractionated Whole Abdominal Radiation Therapy in Combination With Weekly Paclitaxel for Platinum-Resistant Ovarian Cancer (GCGS-01). Int J Radiat Oncol Biol Phys. 2021 Mar 1;109(3):701-711. doi: 10.1016/j.ijrobp.2020.09.059. Epub 2020 Oct 9.
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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.
David SP Tan principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paclitaxel and LDWART (Low Dose Whole Abdominal Radiation Therapy) in people with Ovarian Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 17 inclusion and 34 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 22 Jun 2016. 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 Singapore. 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 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.
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 David SP Tan ((65) 6772 4661, david_sp_tan@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal tolerated dose (MTD) of weekly paclitaxel in combination with LDWART (time frame: Up to 6 weeks from initiation of treatment). 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 NCT02545010, which also lists 3 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 22 Jun 2016.